[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-kidney-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-kidney-disease":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,149,0,25,[9,42,67,93,124,153,182,202,229,250,279,307,331,359,387,409,434,460,483,509,530,564,590,618,642],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100601242","phase-3-a-study-to-find-out-how-empagliflozin-is-tolerated-and-if-it-helps-children-and-adolescents-with-chronic-kidney-disease-empa-kidney-kids-100601242",false,"NCT07107945","A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids)","A Randomised, Double-blind, Placebo-controlled Trial With an Open-label Extension to Assess the Pharmacokinetics, Safety, and Efficacy of Empagliflozin Tablets in Paediatric Patients With Chronic Kidney Disease (EMPA-KIDNEY® Kids)","Inclusion Criteria:\n\n* Signed and dated written informed consent provided by the patient's parent(s) (or legal guardian) and patient's assent in accordance with international council for harmonisation good clinical practice (ICH-GCP) and local legislation prior to admission to the trial (informed assent will be sought according to the patient's age, level of maturity, competence, and capacity).\n* Age 2 to 17 years at screening Visit 1.\n* Chronic kidney disease (CKD) of any underlying aetiology defined by (as measured by central laboratory at screening Visit 1): estimated glomerular filtration rate (eGFR) (U25Crea) ≥20 to \\\u003C90 mL\u002Fmin\u002F1.73 m2 with a urine-albumine-creatinine (UACR) ≥300 mg\u002Fg\n* Participants must be on a stable dose of maximally tolerated standard of care (SoC) therapy for 30 days before screening visit 1 with no plans to change the dose throughout the duration of the placebo-controlled duration of the trial. SoC is anticipated to include a single Renin-angiotensin-aldosterone system (RAAS) inhibitor, such as angiotensin receptor blockers (ARB) or angiotensin converting enzyme inhibitors (ACEi) as appropriate and tolerated. Additional use of a mineralocorticoid receptor antagonist (MRA, including finerenone if available) is permitted if needed and the dose is stable for 30 days before screening Visit 1 and no planned dose changes for the placebo-controlled portion of the trial.\n* Participants receiving daily immunosuppressive therapy for an underlying immunological cause of CKD must be on a stable dose for the duration specified for each drug prior to screening and must remain on a stable regimen throughout the placebo-controlled portion of the trial.\n* Further inclusion criteria apply.\n\nExclusion Criteria:\n\n* Confirmed type 1 or type 2 diabetes mellitus.\n* History of ketoacidosis within 8 weeks prior to Visit 1 and up to randomisation.\n* Chronic dialysis or functioning kidney transplant or scheduled for transplantation throughout the duration of the trial.\n* Diagnosis of uncontrolled metabolic bone disease (at the Investigator's discretion).\n* Body mass index (BMI) ≤10th percentile for children ≥4 years of age and ≤25th percentile for children \\\u003C4 years of age according to Centers for Disease Control and Prevention (CDC) growth chart at screening Visit 1.\n* Gastrointestinal disorders that might interfere with trial drug absorption according to investigator assessment.\n* Presence of acute or active urinary tract infection (UTI) with signs or symptoms of an active UTI or therapeutic treatment for an active UTI within 14 days before screening Visit 1.\n* Severe, uncontrolled hypertension (based on investigator's judgement).\n* Further exclusion criteria apply.","ALL","2 Years","17 Years",{"count":21,"type":22},120,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This study is open to children aged 2 to 17 with chronic kidney disease (CKD). The purpose of this study is to find out if a medicine called empagliflozin helps children and adolescents with CKD. Other goals of the study are to find out how empagliflozin is tolerated and handled by the body in children and adolescents with CKD.\n\nParticipants are put into 2 groups randomly, which means by chance. One group takes empagliflozin and the other group takes placebo. Placebo looks like empagliflozin but does not contain any medicine. Participants are twice as likely to be in the empagliflozin group. Participants take empagliflozin or placebo as tablets once a day for 6 months. After 6 months, participants in both groups take empagliflozin as tablets once a day for 1 year.\n\nParticipants are in the study for a little over a year and a half. During this time, they visit the study site about 15 times and get at least 5 phone or video calls from the site staff. At the visits, the doctors take blood and urine samples from the participants. The doctors also regularly check participants' health and take note of any unwanted effects.",[28],"Chronic Kidney Disease","RECRUITING","2026-08-19",{"date":32,"type":33},"2026-08-20","ACTUAL",{"date":35,"type":33},"2025-12-09",{"date":37,"type":22},"2028-04-14",{"name":39,"class":40},"Boehringer Ingelheim","INDUSTRY",97,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":59,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":66},"100474390","phase-3-a-study-to-learn-more-about-how-safe-the-study-treatment-finerenone-is-in-long-term-use-when-taken-with-an-ace-inhibitor-or-angiotensin-receptor-blocker-over-18-months-of-use-in-children-and-young-adults-from-1-to-18-years-of-age-with-chronic-kidney-disease-and-proteinuria-100474390","NCT05457283","A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria","An 18-month, Open-label, Single-arm Safety Extension Study of an age-and Bodyweight-adjusted Oral Finerenone Regimen, in Addition to an ACEI or ARB, for the Treatment of Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria","FIONA OLE","Inclusion Criteria:\n\n* Participants must be ≥1 year to 18 years of age, at the time of signing the informed consent\u002Fassent.\n* Prior participation in the finerenone Phase 3 study FIONA (19920) and not permanently discontinued from treatment by the end of treatment (EoT) visit in FIONA.\n* Participants must have a clinical diagnosis of chronic kidney disease (CKD) at Visit 1 which is defined as\n\n  * CKD stages 1-3 (estimated glomerular filtration rate \\[eGFR\\] ≥30 mL\u002Fmin\u002F1.73m\\^2) for children ≥1 year to \\\u003C19 years of age at FIONA EoT and at Visit 1\n* Treated with an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at optimized doses defined as maximally tolerable doses within the recommended dose range according to guidelines on blood pressure (BP) management, unchanged for at least 30 days prior to Visit 1.\n* K+ ≤5.0 mmol\u002FL for children ≥2 years of age at both FIONA EoT and Visit 1, and ≤5.3 mmol\u002FL for children \\\u003C2 years of age at both FIONA EoT and Visit 1\n* Participants who have reached legal age of consent: Capable of giving signed informed consent.\n* Participant is able to receive enteral feeding (solid food, bottle or cup fed, feeding through nasogastric or gastric feeding tubes) with or without breastfeeding.\n\nExclusion Criteria:\n\n* Planned urological surgery expected to influence renal function\n* Patients who are candidates for renal transplantation, i.e., a kidney transplantation scheduled within the study time frame\n* Systemic hypertension Stage 2 defined according to institutional guidelines on BP management at Visit 1.\n* Systemic hypotension defined as symptomatic hypotension or a mean systolic BP below the 5th percentile for age, sex and height but no lower than 80 mmHg for participants \\\u003C18 years and symptomatic hypotension or a mean systolic blood pressure (SBP) \\\u003C90 mmHg in participants ≥18 years at Visit 1.\n* Known hypersensitivity to the study treatment (active substance or excipients)\n* Severe hepatic insufficiency defined by e.g. Child-Pugh C or analogous scores.\n* Participants using rituximab, cyclophosphamide, abatacept, or intravenous glucocorticoids\n* Concomitant therapy with a mineralocorticoid receptor antagonist (MRA)(eplerenone, spironolactone, esaxerenone, canrenone), any renin inhibitor (aliskiren, enalkiren, remikiren), any sodium-glucose co-transporter-2 (SGLT2) inhibitor (SGLT2i), sacubitril\u002Fvalsartan combination (ARNI), or potassium-sparing diuretic (amiloride, triamterene)\n* Concomitant therapy with both ACEI and ARBs together\n* Concomitant therapy with strong cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors, moderate or strong CYP3A4 inducers\n* Previous assignment to treatment during this study\n* Simultaneous participation in another interventional clinical study (e.g., Phase 1 to 4 clinical studies).\n* Any suspected (serious) adverse event related to study intervention which led to permanent discontinuation during the FIONA study.\n* Pregnant or breastfeeding or intention to become pregnant during the study","1 Year","18 Years",{"count":53,"type":22},100,[25],"Researchers are looking for a better way to treat children who have chronic kidney disease (CKD), which is long-term kidney disease, and proteinuria, a condition in which a person´s kidneys leak protein into the urine.\n\nThe kidneys filter waste and fluid from the blood to form urine. In children with CKD, the kidney´s filters do not work as well as they should. This can lead to accumulation of waste and fluid in the body and proteinuria. CKD can lead to other medical problems, such as high blood pressure, also known as hypertension. Vice versa, hypertension and proteinuria can also contribute to worsening of CKD. Therefore, the treatment of CKD aims to control blood pressure and proteinuria. There are treatments available for doctors to prescribe to children with CKD and hypertension and\u002For proteinuria. These include \"angiotensin-converting enzyme inhibitors\" (ACEI) and \"angiotensin receptor blockers\" (ARB). Both ACEI and ARB can help improve kidney function by reducing the activity of the renin-angiotensin-aldosterone system (RAAS). The RAAS is a system that works with the kidneys to control blood pressure and the balance of fluid and electrolytes in the blood. In people with CKD, the RAAS is often too active, which can impair the ability of the kidneys to work properly and cause hypertension and proteinuria. However, ACEI or ARB treatment alone does not work for all patients with CKD as they only target the angiotensin part of the renin-angiotensin-aldosterone system.\n\nThe study treatment, finerenone, is expected to help control RAAS overactivation together with an ACEI or ARB.\n\nSo, the researchers in this study want to learn more about whether finerenone given in addition to either an ACEI or ARB can help their kidney function.\n\nThe main purpose of this study is to learn how safe the treatment is when used of finerenone in addition to an ACEI or ARB in long-term.\n\nTo see how safe the treatment is, the study team will collect information on medical problems which are also known as \"treatment emergent adverse events\" (TEAEs). And they will also collect levels of an electrolyte called potassium in the blood by taking blood samples, and measure blood pressure during the study.\n\nThe secondary purpose of this study is to learn how well long-term use of finerenone can reduce the amount of protein in the participants' urine and benefit kidney function when taken with standard of care.\n\nTo see how the treatment works, the study team will collect participants' urine samples to assess urinary albumin-to-creatinine ratio (UACR) and urinary protein-to-creatinine ratio (UPCR), which are important assessments for calculating the level of protein in the urine. Researchers will also collect blood samples to analyze serum creatinine and calculate estimated glomerular filtration rate (eGFR). A significant decline in eGFR indicates worsening kidney function.\n\nThe study will include participants who had previously participated in FIONA study (NCT05196035). The participants will be aged from 1 year up to 18 years.\n\nThe participants will be in the study for approximately 19 months. They will take study treatment for up to 18 months and will be follow up for 1 month. During this period, at least 12 visits are planned for patients who newly start finerenone, and at least 8 visits for patients who already received finerenone.\n\nIn the visit, the study team will:\n\n* have their blood pressure, heart rate, temperature, height and weight measured\n* have blood and urine samples taken\n* have physical examinations\n* have their heart examined by an electrocardiogram and echocardiography (a sonogram of the heart)\n* answer questions about their medication and whether they have any adverse events, or have their parents or guardian's answer\n* answer questions about how they are feeling, or have their parents or guardian's answer\n* answer question about how they like the study medication, or have their parents or guardian's answer The doctors will keep track of any adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.\n\nThe doctors will check the participants' health about 30 days after the participants take their last treatment.",[28,57,58],"Proteinuria","Children",{"date":32,"type":33},{"date":61,"type":33},"2022-11-08",{"date":63,"type":22},"2028-11-07",{"name":65,"class":40},"Bayer",133,{"id":68,"slug":69,"hasResults":12,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":23,"phases":77,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":92},"100637094","phase-1-breakthrough---t1dm-and-chronic-kidney-disease-100637094","NCT07592000","Breakthrough - T1DM and Chronic Kidney Disease","Multicenter, Phase 1\u002F2 Pilot Study of Safety and Efficacy Assessment of Tegoprubart and Calcineurin Inhibitors- Free Immunosuppression Therapy for Pancreatic Islet Transplantation in Patients With T1DM and Chronic Kidney Disease","Participants are eligible for consideration for the study only if all of the following criteria apply at the time of screening Inclusion:\n\n1. Subjects 18-70 years of age.\n2. A diagnosis of T1D ≥5 years with onset of disease at \\\u003C40 years of age.\n3. Ability to provide informed consent.\n4. Able to comply with study procedures, including the requirement to utilize continuous glucose monitoring (CGM).\n5. Involvement in appropriate diabetes management in accordance with the standard of care, using an insulin pump or multiple daily injection (MDI) insulin therapy and, unable to achieve acceptable metabolic control because of the occurrence of unexplained SHEs.\n6. HbA1c level 6.5% to 9.5% inclusive.\n7. Absence of stimulated C-peptide (\\\u003C0.3 ng\u002FmL) in response to a mixed- meal tolerance test (MMTT).\n8. Chronic kidney disease stage 1, 2 or 3a\n9. Impaired awareness of hypoglycemia based on:\n\n   * IAH (HypoA-Q Impaired Awareness Subscale ≥12) and at least one level 3 SHE during the last year or\n   * IAH and time-below-range (\\\u003C70 mg\u002Fdl) ≥4% with level 2 hypoglycemia (\\\u003C54 mg\u002Fdl) ≥1% (in Diabetes Care, Jan 2025, Patrick Choudhary) or\n   * Clarke Score \\>4 or\n   * Recurrent SHE defined by two or more level 3 SHEs in the year prior to screening\n10. If female, must be surgically sterile or postmenopausal. Women of childbearing potential may be enrolled if a pregnancy test is negative at screening\u002Fbaseline. Women of childbearing potential and men with partners that are of childbearing potential must agree to use 2 forms of highly effective methods of contraception from Screening, throughout the study, and while receiving immunosuppressive therapy for the functioning graft after the conclusion of the study. Contraception use must continue for 90 days after the last administration of the study drug (see Appendix 5). Male participants must refrain from donating sperm for the duration of the study and agree to not donate sperm for 90 days after last administration of the study drug.\n\nExclusion Criteria:\n\n1. Body mass index (BMI) \\>30 kg\u002Fm2.\n2. Weight ≤40 kg.\n3. Insulin requirement \\>60units\u002Fday or \\\u003C15 units\u002Fday.\n4. Untreated and uncontrolled proliferative diabetic retinopathy.\n5. Blood pressure: systolic blood pressure (SBP) \\>140 mmHg or diastolic blood pressure (DBP) \\>90 mmHg.\n6. Chronic kidney disease stage 3b or above.\n7. Diagnosis of macroalbuminuria (ACR\\>300 mg\u002Fg creatinine).\n8. For female participants: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 90 days after discontinuation. For male participants: intent to procreate during the duration of the study or within 90 days after discontinuation or unwillingness to use effective measures of contraception.\n9. History of malignancy except for completely resected squamous or basal cell carcinoma of the skin.\n10. History of a thromboembolic event (TE), known hypercoagulable state, or condition requiring long-term anticoagulation:\n\n    1. Participants with a history of clotted venous access not requiring long- term anticoagulation may be included at the Principal Investigator's discretion if they have no other history of TEs or known hypercoagulable state.\n    2. Patients on aspirin are allowed.\n11. Receiving treatment for a medical condition requiring chronic use of systemic steroids, except for physiologic replacement for example in Addison disease.\n12. Presence of ongoing active infection including tuberculosis (TB), human immunodeficiency virus (HIV), hepatitis B, hepatitis C. Laboratory evidence of active infection even in the absence of clinical symptoms of infection is exclusionary.\n13. Invasive aspergillus, histoplasmosis or coccidioidomycosis infection within one year prior to Screening.\n14. Negative screen for Epstein-Barr Virus (EBV) by immunoglobulin G (IgG) determination.\n15. Current treatment with any immunosuppressive regimen, and treatment with biologic immune modulating agents, JAK inhibitors, S1P receptor agonists, azathioprine, 6- MP, or systemic corticosteroids.\n16. Baseline PRA over 40%\n17. Previous organ transplant (except failed pancreas or islet transplant)\n18. Persistent elevation of serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value greater than 3 times the upper limit of normal (ULN); elevation of total bilirubin \\>1.5 ULN.\n19. Any history of receiving experimental cell or gene therapy. Exposure to any other experimental or investigational agent within 30 days or 5 half-lives; whichever is longer.\n20. History of substance abuse within the past 6 months.\n21. Severe cardiovascular disease characterized by any one of these conditions: a) stroke; b) recent myocardial infarction (within past 6 months); c) evidence of ischemia on functional cardiac exam within the last year; d) left ventricular ejection fraction\\\u003C30%.\n22. Significant hyperlipidemia despite medical therapy defined as fasting low-density lipoprotein (LDL) cholesterol \\>130 mg\u002FdL and\u002F or triglycerides \\>200 mg\u002FdL.\n23. Baseline Hb below the lower limits of normal at the local laboratory; lymphopenia (\\\u003C1,000\u002FµL), neutropenia (\\\u003C1,500\u002FµL), or thrombocytopenia (platelets \\\u003C100,000\u002FµL). Participants with lymphopenia are allowed if the Principal Investigator determines there is no additional risk and obtains clearance from a hematologist.\n24. Administration of live attenuated vaccine(s) within 2 months of Screening.\n25. Any previous treatment with Tegoprubart or any other anti-CD40L therapy","70 Years",{"count":76,"type":22},10,[78,79],"PHASE1","PHASE2","Single arm- subject treated with Tegoprubart and everolimus.\n\nThe purpose of this research is to gather information on the safety and effectiveness of investigational regimen containing 2 experimental components:\n\n* An investigational drug called Tegoprubart and\n* Human pancreatic islet cells\n\nBoth Tegoprubart and human pancreatic islet cells are considered investigational because they are not approved for use in the United States by the Food and Drug Administration (FDA). Participation in this research will last about 5 years.\n\nAssess safety, tolerability, and efficacy of transplanted islet cells and immunomodulation with Tegoprubart in combination with anti-thymocyte globulin (ATG), etanercept and with everolimus in adults with brittle T1D and chronic kidney disease (stage 2-3a).",[82,28],"Diabete Type 1","2026-08-18",{"date":32,"type":33},{"date":86,"type":22},"2027-04-29",{"date":88,"type":22},"2030-01-31",{"name":90,"class":91},"University of Chicago","OTHER",2,{"id":94,"slug":95,"hasResults":12,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":23,"phases":104,"briefSummary":105,"conditions":106,"keywords":111,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":116,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":123},"100617944","phase-2-reducing-risk-of-diabetic-ketoacidosis-in-type-1-diabetes-and-kidney-disease-using-continuous-ketone-monitoring-100617944","NCT07325201","Mitigating DKA in Type 1 Diabetes for Safe Use of SGLT Inhibitors Using Dual Continuous Ketone and Glucose Monitoring.","Mitigating Diabetic Ketoacidosis in People With T1D and Chronic Kidney Disease on an SGLT1&2 Inhibitor: Ketosis Risk Factor Determination and Incorporation Into an Enhanced Glucose Ketone Report","SCOUT-CKD","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. Males and females; Ages 18-75.\n4. Diagnosis of type 1 diabetes, based on a clinical diagnosis with onset at least 3 months prior to screening.\n5. Using an automated insulin delivery system (AID) or multiple daily injections (MDI), (defined by use of rapid analogue with meals and approved long-acting analogue (e.g. detemir or glargine)).\n6. Most recent eGFR ≥25 (and within prior 12 months).\n7. HbA1c 7-\\\u003C-9%.\n8. Have never used SGLT2i medications.\n9. Must be willing and able to wear a DGK device and willing to follow the study protocol.\n10. Must be able to read and speak English.\n11. Use of adequate contraception for the duration of the study be the women of childbearing potential.\n12. Access to necessary resources for participating in a technology-based intervention (i.e., computer, smartphone, internet access).\n\nExclusion Criteria:\n\n1. Pregnant, lactating, or planning to become pregnant or unwillingness to be on contraception during the trial.\n2. Any form of diabetes other than T1D.\n3. Any history of use of sodium-glucose cotransporter inhibitors and use of other non-insulin glucose lowering medication within the last 6 months.\n4. Chronic systemic corticosteroids (\\>4 consecutive weeks) within 6 months before screening or planned use during the study period.\n5. History of diabetic ketoacidosis within 3 months of screening or 2 or more episodes of DKA within the last year.\n6. History of multiple (≥ 3 infections) genital mycotic or bacterial infections within 6 months of screening or any history of necrotizing fasciitis.\n7. Hypotension at screening as defined as, systolic blood pressure \\\u003C 90 and diastolic blood pressure \\\u003C 60 with symptoms of low blood pressure (confusion, dizziness, lightheadedness, fainting, heart palpitations).\n8. History of a level 3 hypoglycemic event (as defined by ADA criteria) within 3 months of screening.\n9. Recent myocardial infarction, stroke, hospitalization for unstable angina or heart failure within 3 months prior to screening.\n10. New York Heart Association Class IV heart failure.\n11. CKD-EPI estimated glomerular filtration rate (eGFR) \\\u003C25 mL\u002Fmin\u002F1.73m2.\n12. Impairment of systems and organs that may increase their risk of participating in the intervention study or compromise the results (for example: end stage kidney disease, active liver dysfunction, gastroparesis, anemia, organ transplant).\n13. Active Hepatitis B or C, or tuberculosis.\n14. Abnormal liver function at screening defined as any of the following: aspartate aminotransferase (AST) \\>2X upper limit of the normal reference range (ULN), ALT \\>2X ULN, serum total bilirubin (TB) \\>1.5X ULN.\n15. History of severe acquired immune deficiency syndrome or human immunodeficiency virus (HIV) infection or severely immunocompromised status, in the opinion of the investigator, including, but not limited to patients who have undergone organ or bone marrow transplantation. HIV positive patients who are on stable immunosuppressive therapy and have undetectable viral load may be eligible for inclusion in the study, subject to the investigator's discretion.\n16. Current or past history of decompensated cirrhosis (defined as variceal bleeding, ascites or hepatic encephalopathy), and\u002For known diagnosis of cirrhosis.\n17. Cancer treatment (excluding non-melanoma skin cancer treated by excision, carcinoma in situ of the cervix or uterus, ductal breast cancer in situ, resected non-metastatic breast or prostate cancer) within one year of screening.\n18. History of kidney transplant.\n19. Chronic kidney disease (CKD) from a known cause other than T1D.\n20. Current or clinically significant history of an eating disorder.\n21. BMI \\\u003C22 at time of screening.\n22. Adherence to a very low carbohydrate or ketogenic diet (\\\u003C100g carbohydrate \u002Fday) and unwilling to change during study participation.\n23. History of foot amputation.\n24. Non-healing wounds of extremities.\n25. Documented medical adhesive allergy, as evaluated by investigator.\n26. Inability to perform the study follow up or unwilling to wear the DGK device.\n27. Heavy alcohol use (for men, ≥5 drinks on any day or ≥15 drinks per week; for women, ≥4 drinks on any day or ≥8 drinks per week) at screening, history of alcohol use disorder or binge drinking.\n28. Participation in another treatment or intervention study within the past six weeks.\n29. Any condition or factor that would compromise the participant's safety or conduct of the study (for example: cognitive impairment, bipolar disorder, or eating disorder) or any other reason the PI deems that the patient should not be included.","75 Years",{"count":103,"type":22},80,[79],"The goal of this clinical trial is to develop and evaluate a novel diabetes ketoacidosis risk mitigation strategy to support the safe use of sodium-glucose cotransporter-2 inhibitors (SGLT2i) therapy in participants with type 1 diabetes (T1D) and mild to moderate chronic kidney disease (CKD). The main objectives of this study are to:\n\n1. Evaluate how ketone metrics differ between participants no chronic kidney disease (CKD), moderate risk CKD and high or very high-risk CKD in three time periods.\n2. Identify potentially modifiable ketosis risk factors.\n3. Use continuous dual ketone and glucose monitoring (DGK) data prior to and following treatment to determine ketosis risk factors and gain knowledge to further refine reporting of risk factors and determine which factors in the Ketone Action Plan (KAP) were most valuable.\n4. Gather information on how participants and clinicians like and use the DGK reports.\n\nParticipants will be asked to:\n\n* Meet with study investigators to determine if they are eligible\n* Sign written informed consent\n* Take a pregnancy test, if applicable\n* Have blood taken to assess kidney function and hemoglobin A1c\n* Take the study medication, following the study team instructions\n* Wear the study provided sensor throughout participation.\n* Complete 5 in person visits, and 11 phone check ins over a nine-month period\n* Provide feedback on their experience, usefulness of CGM\u002FCKM reports, and the most valuable factors of the Ketone Action Plan (KAP).",[107,108,28,109,110],"Type 1 Diabetes Mellitus","Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM)","Diabetic Ketoacidosis","Ketones",[112,28,113,109,114],"Type 1 Diabetes","Continuous Glucose Monitoring","Continuous Ketone Monitoring","NOT_YET_RECRUITING",{"date":30,"type":33},{"date":118,"type":22},"2026-09",{"date":120,"type":22},"2028-08",{"name":122,"class":91},"HealthPartners Institute",1,{"id":125,"slug":126,"hasResults":12,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":131,"sex":17,"minAge":51,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":23,"phases":135,"briefSummary":136,"conditions":137,"keywords":138,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":92},"100611013","phase-1-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-ojr520-in-healthy-volunteers-and-participants-with-chronic-kidney-disease-100611013","NCT07235059","Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of OJR520 in Healthy Volunteers and Participants With Chronic Kidney Disease","A Participant- and Investigator--Blinded, Placebo- Controlled, Randomized, Multipart, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of OJR520 in Healthy Volunteers and Participants With Chronic Kidney Disease","Inclusion Criteria:\n\nAble to provide written informed consent before any assessment is performed.\n\nPart A (HV):\n\n• Healthy male and female participants in good health as determined by past medical history, physical examination, vital signs, 12-lead ECG, and laboratory tests at screening and baseline within the normal range.\n\nParts B \\& C (CKD)\n\n• Male and female participants 18 to 65 years of age.\n\nExclusion Criteria:\n\n* Women of childbearing potential.\n* Sexually active males unwilling to use contraception.\n\nPart A (HV):\n\n* Clinically significant abnormal blood pressure, defined as SBP \\\u003C90 mmHg or \\>140 mmHg or DBP \\\u003C55 mmHg or \\>95 mmHg.\n* Abnormal resting HR, defined as \\\u003C45 bpm or \\>90 bpm.\n\nPart B \\& C (CKD)\n\n* History of, or currently active, significant illness or medical disorders including, but not limited to, cancer (except for non-melanoma skin cancer), heart failure NYHA III-IV, heart rhythm abnormalities (e.g., atrial fibrillation, sick sinus syndrome, permanent pacemaker), CKD due to autoimmune disease, kidney transplant, dialysis or any other disease the investigator believes may preclude the participant from participating in the this study.\n* Clinically significant aortic stenosis or mitral insufficiency as identified via echocardiography.\n* History of myocardial infarction (MI), stroke, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), or transient ischemic attack (TIA).\n\nOther protocol defined inclusion\u002Fexclusion criteria may apply.",true,"65 Years",{"count":134,"type":22},112,[78],"The purpose of this first-in-human (FIH) study is to evaluate safety, tolerability, pharmacokinetic (PK) of OJR520.",[28],[139,140,141,142,143,144,145],"OJR520","safety and tolerability","PK","PD","healthy volunteers","first in human","chronic kidney disease",{"date":30,"type":33},{"date":148,"type":33},"2025-11-20",{"date":150,"type":22},"2028-01-21",{"name":152,"class":40},"Novartis Pharmaceuticals",{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":131,"sex":17,"minAge":18,"maxAge":159,"enrollmentInfo":160,"targetDuration":4,"studyType":162,"phases":4,"briefSummary":163,"conditions":164,"keywords":169,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":174,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":123},"100469897","a-natural-history-study-of-metabolic-sizing-in-health-and-disease-100469897","NCT05398783","A Natural History Study of Metabolic Sizing in Health and Disease","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all the following criteria for their cohort:\n\nCohort 1 - Healthy Volunteers\n\n* Male or female, aged \\>=2 years\n* In good general health as evidenced by medical history\n\nCohort 2 - Patients\n\n* Male or female, aged \\>=2 years\n* Diagnosed with diseases thought to alter metabolism or body composition (such as weight loss or gain, diabetes, renal disease, obesity, cancer, etc.) or taking medications thought to alter metabolism or body composition.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Participants over 200 kg due to the weight limit of the equipment.\n* Presence of any implanted device that would interfere with measurements.\n* Any moderate to severe limitations in mobility that would impede participation\n* Hemoglobin less than 10 g\u002FdL (in participants who would have blood drawn for research purposes).\n* Participants with dietary allergies, intolerances or eating patterns that would preclude them from consuming metabolic meals.\n* Participants unwilling or unable to give informed consent.\n* Participants with any other significant physical, medical, or psychiatric limitations, illness or conditions that may preclude them from completing the majority of the tests in this study per the discretion of the PI.","99 Years",{"count":161,"type":22},2000,"OBSERVATIONAL","Background:\n\nScientists have long used simple measures (such as height and weight) to estimate how much a person s body uses food (calories) as energy, as commonly called the metabolic rate. But metabolism varies among people with similar body sizes. Scientists now believe the old formulas for estimating metabolic rates may not work well for all people. Researchers want to find more accurate ways to measure a person s metabolism.\n\nObjective:\n\nThis natural history study will examine the relationships between metabolism, body composition, and body surface area in a wide range of people.\n\nEligibility:\n\nHealthy children and adults aged 2 years or older. Also, people aged 2 years or older with conditions that may alter metabolism. These may include diabetes, obesity, renal disease, or cancer.\n\nDesign:\n\nParticipants will spend 2 days and 1 night in the hospital. They will provide a medical history and answer questions about their activity levels, the foods they eat, and their lifestyle. They will also eat a special diet.\n\nParticipants will undergo many tests:\n\nThey will lie in a bed with a clear hood covering their head for 30 to 45 minutes to measure the gases in their breath.\n\nThey will lie on a padded table for about 15 minutes while their body is scanned.\n\nThey will stand on a platform while a 3D scanner measures their body.\n\nThey will have a test to measure how fast an electric signal moves through their body.\n\nThey will grip an instrument to measure the strength of their hands.\n\nThey will drink salty water and provide blood and urine samples.\n\nParticipants may be invited to return for these 2-day visits up to 8 times per year. Return visits must be at least 2 weeks apart.",[165,166,28,167,168],"Metabolic Disorders","Cancer","Diabetes","Normal Physiology",[170,171,172,173],"Body Composition","Metabolism","Body Surface Area","Natural History",{"date":30,"type":33},{"date":176,"type":33},"2022-10-25",{"date":178,"type":22},"2031-07-01",{"name":180,"class":181},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",{"id":183,"slug":184,"hasResults":12,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":131,"sex":17,"minAge":51,"maxAge":189,"enrollmentInfo":190,"targetDuration":4,"studyType":23,"phases":192,"briefSummary":193,"conditions":194,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":123},"100648546","phase-1-a-study-to-learn-about-how-a-new-nurandociguat-tablet-is-absorbed-and-processed-in-the-body-compared-to-an-old-tablet-and-how-food-affects-the-way-the-new-tablet-is-absorbed-and-processed-in-the-body-100648546","NCT07722585","A Study to Learn About How a New Nurandociguat Tablet is Absorbed and Processed in the Body Compared to an Old Tablet and How Food Affects the Way the New Tablet is Absorbed and Processed in the Body","A Single Center, Open-label Study Assessing the Relative Bioavailability of a New Nurandociguat Tablet Formulation Versus an Existing Formulation and Investigating the Food Effect of the New Tablet Formulation","Inclusion Criteria:\n\n* Participant must be 18 to 58 years of age inclusive, at the time of signing the informed consent.\n* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs (blood pressure and heart rate), electrocardiogram (ECG), body temperature, and laboratory tests.\n* Body Mass Index (BMI) within the range 18.0 and 29.9 kg\u002Fm\\^2 (inclusive).\n* Body weight above or equal 60 kg.\n* Male and female.\n\nExclusion Criteria:\n\n* Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study interventions will not be normal.\n* Acute diarrhea or constipation within 14 days before the first intake of study intervention.\n* Regular use of medicines within the last 14 days before the first study intervention administration.\n* Special diets preventing the participants from eating the standard meals during the study.\n* Participant is unable or unwilling to comply with study restrictions.","58 Years",{"count":191,"type":22},18,[78],"Researchers conduct this clinical study to learn more about a new tablet of a medicine called nurandociguat. Nurandociguat is being developed as a possible treatment for people with chronic kidney disease (CKD) which is a long-term condition in which the ability of the kidneys to properly function decreases over time. It is often caused by high blood glucose levels.\n\nThe main purposes of the study are\n\n* To learn how the new nurandociguat tablet is absorbed and processed in the body (which is also known as \"pharmacokinetics \\[PK\\]\" measurement) compared to an old tablet when taken without food.\n* To learn how food affects the way the new tablet is absorbed and processed in the body when taken with a high-fat, high-calorie meal (like a big breakfast).\n\nTo do this, researchers will take blood samples from the participants and measure:\n\n* Maximum observed concentration (Cmax): the highest concentration of nurandociguat in participants' plasma\n* Area under the concentration time curve (AUC): the total amount of nurandociguat in participants' plasma over time Another purpose of this study is to learn how safe the new nurandociguat tablet is. Therefore researchers will monitor the number of participants who experience medical problems during this study. These medical problems are called adverse events.\n\nOnly healthy participants are taking part in this study. During the study, participants will receive 2 different types of nurandociguat tablets. These include the newly developed tablet and an existing tablet that has already been used in previous clinical studies. Each participant will receive 3 different treatments:\n\n* Treatment A: Nurandociguat old tablet, taken without food\n* Treatment B: Nurandociguat new tablet, taken without food\n* Treatment C: Nurandociguat new tablet, taken with food Researchers have proposed 5 optional dosing schemes for this clinical study, however only one scheme will be selected based on the findings from an ongoing clinical study. Afterwards, the study will start.\n* For Optional Scheme 1-3, each participant will receive the three treatments A, B, and C, one at a time, in a different order for each participant with a break of at least 7 days between treatments.\n* The Optional Schemes 4-5 follow a fixed sequence design. Each participant will first receive the nurandociguat new tablet formulation at a lower dose for 7 days, then receive the higher dose for in total 11 days. The higher dose will be administered for 5 days using the old tablet formulation followed by 6 days using the new tablet formulation. PK measurement will be assessed after 5 days of treatment with the old tablet formulation (without food), after 5 days of treatment with the new tablet formulation (without food) and after 6 days of treatment with the new tablet formulation (with food).\n\nThe researchers will closely monitor and manage any medical problems that the participants may have during the study.",[28],"2026-08-17",{"date":30,"type":33},{"date":198,"type":33},"2026-07-28",{"date":200,"type":22},"2026-11-04",{"name":65,"class":40},{"id":203,"slug":204,"hasResults":12,"nctId":205,"briefTitle":206,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":131,"sex":17,"minAge":209,"maxAge":210,"enrollmentInfo":211,"targetDuration":4,"studyType":162,"phases":4,"briefSummary":213,"conditions":214,"keywords":216,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":123},"100651916","arterial-stiffness-in-children-and-young-people-with-hypertension-and-chronic-kidney-disease-100651916","NCT07768865","Arterial Stiffness in Children and Young People With Hypertension and Chronic Kidney Disease","ART-KIDS","Inclusion criteria:\n\nFor CKD participants:\n\n* Aged 10-25 years at study entry.\n* Diagnosis of CKD confirmed on at least two GFR assessments 3-months apart; eGFR will be estimated using routine bedside formulae (modified Schwartz). Participants may include those on dialysis or those with a functioning kidney transplant.\n* Able to tolerate study investigations including 24-hour ABPM, echocardiogram, vascular assessments and MRI.\n\nFor controls:\n\n* Aged 10-25 years at study entry\n* Having completed study measurements as part of other research being completed by the research group and having consented to their anonymised data being used in future research within the same research theme.\n\nExclusion criteria (for all participants):\n\n* Heart abnormalities or pre-existing cardiac disease including congenital heart disease, previous cardiac surgery or heart failure.\n* Cardiac dysrhythmia.\n* Inability to tolerate the required study investigations (out of office BP monitoring, applanation tonometry, cardiac MRI).","10 Years","25 Years",{"count":212,"type":22},200,"Age related stiffening and hardening of the arteries is often a slow process, but some conditions such as chronic kidney disease (CKD), seem to increase the rate at which the arteries stiffen even during childhood. High blood pressure (BP) is well known to lead to arterial stiffening and is often seen in children and young people (CYP) with CKD.\n\nA greater risk of arterial stiffening has been reported in children CYP with CKD compared to healthy CYP and this is thought to be related to the development of high BP, heart problems, and the worsening of kidney damage. The cause is unknown and is unlikely due to age related changes in the arterial wall seen in older adults. Potential mechanisms contributing to arterial stiffening in CYP with CKD include i) abnormalities in the interaction between the heart and the aorta (the large artery pumping blood away from the heart to the rest of the body), overactivity of the sympathetic nervous system (SNS), the body's \"stress response\", or iii) abnormal metabolism seen in CKD, where there are high levels of phosphate and other waste products circulating in the blood as a result of damage to the kidneys.\n\nIn this study, the investigators will use a variety of non invasive experimental methods to determine if arterial stiffening seen in CYP with CKD is due solely to increased BP, or whether the other potential factors listed above also contribute. This may help to eventually identify how to prevent or treat arterial stiffness in CYP with CKD and prevent its adverse impact on kidney and heart health in later life. The investigators will compare findings between those with CKD and an age, sex and BP matched control group. This control group will comprise CYP both with high BP (primary hypertension) and without high BP (healthy participants).",[28,215],"Hypertension",[217,215,218,58,219,220],"Chronic kidney disease","Arterial stiffness","Pulse wave velocity","Cardiac MRI","2026-08-12",{"date":195,"type":33},{"date":224,"type":33},"2026-06-16",{"date":226,"type":22},"2028-06-16",{"name":228,"class":91},"King's College London",{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":236,"targetDuration":238,"studyType":162,"phases":4,"briefSummary":239,"conditions":240,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":249},"100629965","a-prospecitve-multicenter-observational-registry-study-100629965","NCT07481526","A Prospecitve Multicenter, Observational Registry Study","A Multicenter Real-World Registry of Characteristics, Treatment Strategies, and Clinical Outcomes in Chinese Adults With Chronic Kidney Disease","Inclusion Criteria:\n\n* Male or female patients aged ≥18 years.\n* Willing and able to provide written informed consent to participate in the study.\n* Confirmed CKD diagnosis at enrolment, defined by at least one of the following:\n\n  * eGFR \\\u003C60 mL\u002Fmin\u002F1.73 m² for ≥3 months, OR\n  * Evidence of kidney damage (e.g., UACR ≥30 mg\u002Fg or UPCR ≥150 mg\u002Fg, structural abnormality on imaging, or kidney biopsy findings consistent with chronic kidney injury) persisting for ≥3 months\n\nExclusion Criteria:\n\n* Having a life-threatening comorbidity with life expectancy \\\u003C 2 years.\n* Severe cardiac disease: life-threatening arrhythmias, or recent MACE (Myocardial infarction (MI), stroke, CV death) within the past 3 months.\n* Pregnant or breastfeeding women.\n* Currently enrolled in any interventional clinical trial or receiving investigational therapy within 3 months of enrollment.\n* Presenting with ESRD, RRT, acute kidney injury (AKI), acute kidney disease (i.e., kidney injury or a decline in renal function persisting for ≤3 months) as a primary disease condition at enrollment.",{"count":237,"type":22},3000,"96 Weeks","This is a prospective, multicenter, observational registry study designed to collect data to deepen the understanding of CKD therapeutics, changes in clinical practice, cardiorenal risk outcomes and differences in treatment approaches in Chinese CKD patients.",[28],{"date":242,"type":33},"2026-08-13",{"date":244,"type":33},"2026-02-27",{"date":246,"type":22},"2028-12-30",{"name":248,"class":40},"AstraZeneca",59,{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":131,"sex":17,"minAge":51,"maxAge":101,"enrollmentInfo":257,"targetDuration":4,"studyType":23,"phases":259,"briefSummary":260,"conditions":261,"keywords":262,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":278},"100594851","phase-1-a-study-to-investigate-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-azd4248-in-healthy-participants-and-participants-with-chronic-kidney-disease-and-type-2-diabetes-and-to-assess-home-measurements-of-creatinine-in-a-non-interventional-cohort-100594851","NCT07024823","A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4248 in Healthy Participants and Participants With Chronic Kidney Disease and Type 2 Diabetes and to Assess Home Measurements of Creatinine in a Non Interventional Cohort","A Phase I Randomized, Single-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4248 Following Single and Multiple Ascending Dose Administration in Healthy Participants and Participants With Chronic Kidney Disease and Type 2 Diabetes and to Assess Home Measurements of Creatinine in a Prospective, Non-interventional Cohort Study","Key Inclusion Criteria:\n\n\\- Healthy participants with suitable veins for cannulation or repeated venipuncture.\n\nParts A and B:\n\n* Have a body mass index (BMI) between 18 and 30 kilograms per millimeter (kg\u002Fm2), inclusive.\n* For Chinese participants (Part A2): participants are to be Chinese, defined as having both parents and 4 grandparents who are Chinese. This includes second and third generation participants of Chinese descent whose parents or grandparents are living in a country other than China.\n* For Japanese participants (Part B2): participants are to be Japanese, defined as having both parents and 4 grandparents who are Japanese. This includes second and third generation participants of Japanese descent whose parents or grandparents are living in a country other than Japan.\n\nPart C:\n\n* Have a BMI between 20 and 40 kg\u002Fm2, inclusive.\n* Have a diagnosis of diabetic kidney disease (DKD).\n* Hemoglobin A1C (HbA1c) of ≤ 10.5%.\n* Participants are required to be on a stable dose of angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) for at least 6 weeks prior to Visit 1 and throughout the Screening Period. In addition, participants should be on stable doses of all other medication for ≥ 6 weeks before Screening.\n\nPart D:\n\n* Have a BMI between 20 and 35 kg\u002Fm2, inclusive.\n* Have a diagnosis of DKD as defined by a) diagnosis of type 2 diabetes (T2D) b) eGFR values and c) urine albumin to creatinine ratio (UACR) values.\n* HbA1c of ≤ 10.5%.\n* Participants are required to be on a stable dose of ACEi or ARB for at least 6 weeks prior to Visit 1 and throughout the Screening Period. In addition, participants should be on stable doses of all other medication for ≥ 6 weeks before Screening.\n* Participants must be able and motivated to use the home creatinine device and smartphone independently by successfully performing the test without assistance from site staff.\n* Participants must be able to read and understand English sufficient to participate in site visits and home testing.\n\nKey Exclusion Criteria:\n\n* History of any clinically important disease or disorder which may put the participant at risk because of participation in the study or influence the results.\n* Any positive result on Screening for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or human immunodeficiency virus (HIV).\n\nParts A and B:\n\n* History or presence of gastrointestinal, hepatic, or renal disease.\n* Any clinically important illness, medical\u002Fsurgical procedure, or trauma within 4 weeks of the first administration of study intervention.\n* History of severe allergy\u002Fhypersensitivity or ongoing clinically important allergy\u002Fhypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD4248.\n* Participants who have previously received AZD4248.\n\nPart C:\n\n* History or presence of gastrointestinal, hepatic, or renal disease.\n* Any clinically important illness, medical\u002Fsurgical procedure, or trauma within 4 weeks of the first administration of study intervention.\n* History of severe allergy\u002Fhypersensitivity or ongoing clinically important allergy\u002Fhypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD4248.\n* Use of drugs that are strong or moderate CYP3A4 inhibitors\u002Finducers or P-gp inhibitors from within 3 weeks before Screening until the end of the last sample collection.\n* Participants who have previously received AZD4248.\n* Participants on serum creatinine-altering drugs should be on long-term treatment at a stable dose prior to study entry.\n* Expected change of dosing regimen during the study.\n* History of clinically significant heart or vascular disease.\n* New York Heart Association Class 2, 3, or 4 or history of hospitalization for heart failure within 6 months of screening.\n* Ventricular arrhythmias requiring treatment.\n* Amputation due to peripheral artery disease.\n* Severe chronic obstructive pulmonary disease as judged by the Investigator or hospitalization for exacerbation in the last 6 months.\n\nPart D:\n\n* Participants on serum creatinine-altering drugs should be on long-term treatment at a stable dose prior to study entry.\n* Expected change of dosing regimen during the study.",{"count":258,"type":22},124,[78],"This study will evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses (SAD) and multiple ascending doses (MAD) of AZD4248 administered as an oral solution and intravenous (IV) infusion. Additionally, the study investigates the non-interventional feasibility of home measurement of serum creatinine in participants with diabetic kidney disease (DKD).",[28],[263,264,265,266,267,268,269,270],"Type 2 Diabetes","Diabetic Kidney Disease","Multiple Ascending Dose","Single Ascending Dose","Creatinine","Food Effect","Pharmacokinetics","Safety","2026-08-11",{"date":221,"type":33},{"date":274,"type":33},"2025-06-09",{"date":276,"type":22},"2026-12-25",{"name":248,"class":40},5,{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":285,"eligibilityCriteria":286,"healthyVolunteers":12,"sex":17,"minAge":287,"maxAge":101,"enrollmentInfo":288,"targetDuration":4,"studyType":23,"phases":290,"briefSummary":292,"conditions":293,"keywords":295,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":123},"100626547","early-phase-1-sarcopenia-in-chronic-kidney-disease-ckd-patients-100626547","NCT07437053","Sarcopenia in Chronic Kidney Disease (CKD) Patients","Branched-chain Amino Acids to Improve Sarcopenia in Patients With Advanced Chronic Kidney Disease (BOOST-CKD)","BOOST_CKD","Inclusion Criteria:\n\n1. Ability of participant to understand and the willingness to sign a written informed consent document.\n2. Males and females of age 45-75 yrs\n3. Hand grip strength of \\\u003C26 kg for male and \\\u003C16 kg for female\n4. Documented diagnosis of estimated glomerular filtration rate (eGFR) of ≤15 mL\u002Fmin\u002F1.73 m2, based on CKD-EPI serum-creatinine based formula in the past ≥3 months in absence of acute kidney injury.\n5. Not on dialysis and is not expected to initiate dialysis or any kidney replacement therapy in next 4 months\n6. Receiving standard of care including dietary recommendation for diabetes, hypertension, CKD, and other comorbidities\n7. Patients who are on an SGLT2-i or GLP-1 agonist should be on a stable dose for at least 3 months prior randomization, with no dose adjustments expected in the next 4 months\n8. Serum HCO3 concentration 20-29 mmol\u002FL based on two consecutive recent routine labs\n9. HbA1c 7-9% based on most recent routine lab\n10. Serum albumin ≥3.8 g\u002FdL based on most recent routine lab\n11. Blood hemoglobin ≥10 g\u002FdL based on most recent routine lab\n12. Willingness to adhere to lifestyle management, including diet and exercise as recommended by care providers, and to the study intervention, procedures, and regimen.\n\nExclusion Criteria:\n\n1. Any known history of hypersensitivity\u002Fintolerance to valine or specific amino acids\n2. Any condition that may indicate the individual is not \"metabolically stable\" which may include active infection, currently on systemic antibiotic, hospitalization within 2 weeks on consenting, active malignancy, on immunosuppressive agents, and unexplained significant weight loss during the past 3 months\n3. With a cardiac pacemaker and\u002For an implantable cardioverter-defibrillator\n4. Significant arthritis prohibiting strength test and walk gait speed test\n5. Significant comorbidities including heart failure (NY Class III or IV), neurological disorders, HIV AIDS, etiology of CKD other than diabetes and hypertension, or any condition that could compromise the subject's ability to study procedures as judged by study clinician\n6. Currently taking any protein supplements\n7. Pregnant, lactating, childbearing women\n8. History of Maple syrup urine disease (MSUD)\n9. Scheduled for kidney transplantation or dialysis in next 4 months\n10. Current participation in another interventional trial\n11. Documented noncompliance with regard to clinic visits, medications, and lifestyle management.\n12. Documentation of current or history of substance abuse.","45 Years",{"count":289,"type":22},20,[291],"EARLY_PHASE1","Sarcopenia, or loss of muscle and strength is common in patients with poor kidney function. Although a high protein diet is generally recommended for sarcopenia, patients with poor kidney function are advised to follow a low-protein diet. In this study, we will evaluate the practicality and potential benefits of two different amino acids (molecules that form proteins) in improving sarcopenia in patients with advanced kidney disease.\n\nThe study aims to improve muscle mass and strength. All study procedures are free of cost and do not require significant time commitment. You will have time to ask questions and discuss the study with your family, primary care physician, and your kidney doctor to make the decision if this is right study for you to participate in.",[28,294],"Sarcopenia",[296,297,298],"Valine","Essential amino acid","Metabolic effects","2026-08-07",{"date":271,"type":33},{"date":302,"type":22},"2026-08-24",{"date":304,"type":22},"2027-10-30",{"name":306,"class":91},"The University of Texas Health Science Center at San Antonio",{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":23,"phases":316,"briefSummary":318,"conditions":319,"keywords":320,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":92},"100651361","food-as-medicine-to-reduce-ckd-burden-in-health-disparity-populations-100651361","NCT07759401","Food As Medicine to Reduce CKD Burden in Health Disparity Populations","FAME-CKD","Inclusion Criteria:\n\n* men and women of age ≥ 18 years and able to give consent;\n* willingness to participate in a 12-month study;\n* elevated albumin to creatinine ratio (ACR) (≥ 30 mg\u002Fg) determined by point-of-care urine dipstick during health screen;\n* Reside in a low-income area or visit a food pantry due to food insecurity\n\nExclusion Criteria:\n\n* whose urine dipstick does not indicate micro- or macro-albuminuria (ACR \\\u003C30 mg\u002Fg),\n* currently receiving dialysis or need dialysis,\n* have received or need a kidney transplant,\n* pregnant or plan to become pregnant in the next 12 months,\n* baseline urine potassium \\> 60 mEq\u002Fg creatinine (baseline excretion below this level was not associated with hyperkalemia when fruit\u002Fvegetable were paired with kidney-protective drugs,\n* urine ACR values indicate nephrotic proteinuria, and\n* CKD stage 5 demonstrated by elevated estimated glomerular filtration rate (eGFR) obtained during baseline measures.",{"count":315,"type":22},500,[317],"NA","Healthy eating plays an important role in kidney and heart health, and programs that use food as medicine can help improve diet and overall health, but the best ways to support healthy eating in community settings are not well understood. The purpose of this study is to compare two study groups to see which is more effective at improving kidney health and related health outcomes in adults with chronic kidney disease. One group receives fruits and vegetables with cooking education, and the other receives fruits and vegetables alone. The results may help researchers develop community-based programs to improve kidney and heart health, especially in populations at higher risk for kidney disease.\n\nIf the participant joins the study, the participant will complete a baseline visit, a 6-month visit, and a 12-month visit. Visits include questionnaires about the participant's health, diet, and cooking habits; a urine sample; a blood sample; blood pressure, height, weight, and waist measurements; and a brief, painless Veggie Meter® scan to measure fruit and vegetable intake. Participants will pick up weekly fruits and vegetables for 12 months. Those in the cooking group will also attend 12 weekly cooking and nutrition classes and receive follow-up newsletters and optional monthly virtual sessions. Depending on the group to which the participants are assigned, the total time commitment for the participants in this study will range from approximately 3 to 15 hours.\n\nParticipation is voluntary, involves minimal risk, and all information will be kept private. Possible risks include brief pain or bruising from the blood draw, mild discomfort from urine collection, minor risk of cuts or burns during cooking, and some questions may feel personal; the participant may skip any question. There may be no direct benefit to the participant, but the participant's participation may help improve nutrition and kidney health programs in the community.",[28],[28,321,322],"CKD","Food is Medicine","2026-08-06",{"date":221,"type":33},{"date":326,"type":22},"2026-10",{"date":328,"type":22},"2032-10",{"name":330,"class":91},"University of Texas Southwestern Medical Center",{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":12,"sex":17,"minAge":338,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":23,"phases":341,"briefSummary":342,"conditions":343,"keywords":345,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":358},"100611500","phase-3-a-study-of-orforglipron-ly3502970-on-cardiovascular-outcomes-in-adults-with-atherosclerotic-cardiovascular-disease-andor-chronic-kidney-disease-attain-outcomes-100611500","NCT07241390","A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and\u002For Chronic Kidney Disease (ATTAIN-Outcomes)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Orforglipron on the Incidence of Major Adverse Cardiovascular Events in Participants With Established Atherosclerotic Cardiovascular Disease and\u002For Chronic Kidney Disease","Inclusion Criteria:\n\n* Have established ASCVD and\u002For CKD\n\nExclusion Criteria:\n\n* Have type 1 diabetes\n* Have had a major heart condition within 60 days prior to screening\n* Have New York Heart Association Functional Classification Class IV heart failure","50 Years",{"count":340,"type":22},7140,[25],"The purpose of this study is to measure cardiovascular outcomes with orforglipron compared with placebo in participants with atherosclerotic cardiovascular disease (ASCVD) and\u002For chronic kidney disease (CKD). Participation in the study will last about 5 years.",[344,28],"Atherosclerosis Cardiovascular Disease",[346,347,348,349],"Heart Disease","Kidney Disease","Outcomes","Stroke","2026-08-05",{"date":323,"type":33},{"date":353,"type":33},"2025-12-01",{"date":355,"type":22},"2031-08",{"name":357,"class":40},"Eli Lilly and Company",567,{"id":360,"slug":361,"hasResults":12,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":17,"minAge":366,"maxAge":367,"enrollmentInfo":368,"targetDuration":4,"studyType":162,"phases":4,"briefSummary":370,"conditions":371,"keywords":372,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":123},"100651099","self-management-data-and-disease-progression-in-chronic-kidney-disease-100651099","NCT07754097","Self-Management Data and Disease Progression in Chronic Kidney Disease","A Non-Interventional, Prospective Observational Study to Evaluate Disease Progression and Management Characteristics for the Development of an Integrated Self-Management Data Application in Chronic Kidney Disease","Inclusion Criteria:\n\n1. Adult patients aged 19 years or older and under 85 years.\n2. Patients visiting the hospital for chronic kidney disease (CKD) management.\n3. Patients diagnosed with CKD or identified as high-risk for CKD requiring continuous management (e.g., diabetes mellitus, hypertension, proteinuria, or decreased eGFR).\n4. Patients capable of recording self-management data (blood pressure, diet, medication) independently or with assistance through the provided mobile application.\n5. Patients whose clinical data can be collected from the Hospital Information System (HIS).\n\nExclusion Criteria:\n\n1. Patients who do not sign the informed consent form or lack the capacity to fully understand the study protocol and express voluntary consent.\n2. Patients currently undergoing maintenance dialysis (hemodialysis or peritoneal dialysis) for end-stage kidney disease (ESKD).\n3. Patients deemed unsuitable for participation in the study by the investigator.","19 Years","84 Years",{"count":369,"type":22},300,"This study evaluates disease progression and management characteristics in patients with chronic kidney disease (CKD) using an integrated mobile application and hospital information system (HIS) clinical data.\n\nThe main goals of this study are:\n\n1. To observe patient self-management recording performance and adherence (continuity of recording blood pressure, blood glucose, medication, and diet).\n2. To explore associations between integrated self-management data and disease progression or acute exacerbations (e.g., acute kidney injury, hyperkalemia).\n3. To gather foundational evidence for optimizing and improving future digital health applications for CKD management.\n\nParticipants will be recruited from outpatient clinics at Chungnam National University Hospital and followed prospectively for 1 year with regular follow-up visits.",[28,321],[373,374,375,376,377],"Self-Management","Mobile Application","Personal Health Record","Hospital Information System","Prospective Observational Study","2026-08-04",{"date":380,"type":33},"2026-08-10",{"date":382,"type":33},"2026-06-11",{"date":384,"type":22},"2029-06-11",{"name":386,"class":91},"Chungnam National University Hospital",{"id":388,"slug":389,"hasResults":12,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":393,"eligibilityCriteria":394,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":395,"targetDuration":4,"studyType":23,"phases":397,"briefSummary":398,"conditions":399,"keywords":400,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":402,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":408},"100650917","a-study-to-investigate-outcomes-with-elecoglipron-compared-with-placebo-in-adult-participants-with-chronic-kidney-disease-100650917","NCT07753993","A Study to Investigate Outcomes With Elecoglipron Compared With Placebo in Adult Participants With Chronic Kidney Disease.","A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Renal Outcomes and Mortality in Participants With Chronic Kidney Disease (Elevate-CKD)","Elevate-CKD","Inclusion Criteria:\n\n* Adults with confirmed CKD; UACR ≥30 mg\u002Fg and eGFR ≥20 mL\u002Fmin\u002F1.73 m² within specified ranges.\n* On stable, patient maximum tolerated, labeled daily dose of ACEI or ARB for ≥4 weeks at least 28 days before screening.\n\nExclusion Criteria:\n\n* BMI \\\u003C23 kg\u002Fm² at screening\n* History of type 1 diabetes mellitus\n* HbA1c ≥10% (86 mmol\u002Fmol) at screening\n* Currently receiving, or anticipated to receive, therapeutic intervention for diabetic retinopathy and\u002For macular edema.\n* Have had more than one episode of severe hypoglycemia within 180 days prior to screening, or hypoglycemia unawareness\n* Acute coronary syndrome, major cardiac procedure, stroke, or TIA within 3 months prior to screening\n* Clinically significant condition affecting the upper GI tract or chronic use of any medication that affects gastric motility or gastric emptying\n* History of acute or chronic pancreatitis\n* History\u002Ffamily history (first degree) of medullary thyroid cancer or MEN2",{"count":396,"type":22},7000,[25],"This is a Phase III, randomized, double-blind, parallel-group, placebo-controlled multicenter study to investigate outcomes with elecoglipron compared with placebo in participants with CKD with and without T2DM who are on background SGLT2i (dapagliflozin) as GDMT and other SoC treatments for CKD.",[28],[217,401],"Elecoglipron",{"date":380,"type":33},{"date":404,"type":22},"2026-08-28",{"date":406,"type":22},"2030-10-04",{"name":248,"class":40},426,{"id":410,"slug":411,"hasResults":12,"nctId":412,"briefTitle":413,"officialTitle":413,"acronym":4,"eligibilityCriteria":414,"healthyVolunteers":131,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":415,"targetDuration":4,"studyType":23,"phases":417,"briefSummary":418,"conditions":419,"keywords":424,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":92},"100650142","assessment-of-the-impact-of-repeated-ischemic-preconditioning-episodes-on-hemodynamic-and-metabolic-parameters-in-patients-at-various-stages-of-chronic-kidney-disease-100650142","NCT07746102","Assessment of the Impact of Repeated Ischemic Preconditioning Episodes on Hemodynamic and Metabolic Parameters in Patients at Various Stages of Chronic Kidney Disease","Inclusion Criteria:\n\n* obtaining the patient's voluntary, informed consent to participate in the experiment,\n* chronic kidney disease in stages G1-G5,\n* women and men over 18 years of age.\n* failure to meet the qualification criteria for participation in the study,\n* consciousness disorders,\n* heart failure (NYHA IV),\n* severe anemia (Hb concentration\\\u003C8g\u002FdL),\n* features of muscle cell damage (e.g. rhabdomyolysis),\n* peripheral circulation disorders, peripheral vascular diseases.\n\nExclusion Criteria:\n\n\\-",{"count":416,"type":22},60,[317],"The aim of our study is to evaluate the impact of repeated episodes of ischemic quenching on changes in blood pressure, heart rate and laboratory parameters of inflammation in patients with kidney diseases. There is credible evidence that intentionally producing periods of ischemia provides protection of the myocardium and blood vessels against subsequent ischemic injury. The examination will be performed during hospitalization in the Department of Nephrology, Hypertension, Transplantology and Internal Diseases and will last 4 days. On the first day, blood pressure will be measured using an automatic blood pressure monitor, radial artery pulse, blood saturation will be measured using a pulse oximeter, and approximately 6 ml of venous blood will be collected from the elbow bend area for laboratory tests. Then, compression of the lower limb below the knee will be performed using a blood pressure cuff. Four 5-minute cycles of inflation and deflation of the cuff will be performed. The pressure on the lower limb will be repeated on the next two days. On the last day of the examination, blood pressure, heart rate and blood saturation will be measured again, and approximately 6 ml of venous blood will be collected again for laboratory tests.",[420,421,28,422,423],"Hemodialysis","Ischemia Preconditioning","Blood Pressure Disorders","Inflammation",[420,425],"ischemia preconditioning","2026-08-03",{"date":378,"type":33},{"date":429,"type":22},"2026-07-23",{"date":431,"type":22},"2026-12-31",{"name":433,"class":91},"Medical University of Lodz",{"id":435,"slug":436,"hasResults":12,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":440,"eligibilityCriteria":441,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":442,"targetDuration":4,"studyType":23,"phases":444,"briefSummary":445,"conditions":446,"keywords":449,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":123},"100650050","phase-1-pharmacokinetics-of-zoledronic-acid-in-patients-on-dialysis-100650050","NCT07741136","Pharmacokinetics of Zoledronic Acid in Patients on Dialysis","Pharmacokinetics of Zoledronic Acid in Patients With Chronic Kidney Disease on Dialysis","ZADIAL","Inclusion Criteria:\n\n* Individuals aged 18 years or older, with CKD-associated osteoporosis\n* eGFR ≥ 35 mL\u002Fmin\u002F1.73 m2 and advanced CKD on dialysis\n* Agree to participate in the research by signing the informed consent form\n\nExclusion Criteria:\n\n* Individuals under 18 years of age, pregnant or breastfeeding women\n* Patients with CKD with hypocalcemia\u002Fhypophsphatemia\n* Patients with CKD on dialysis with residual diuresis\\*\n* Patients with CKD on low-flux membrane dialysis\\*\n* Patients with neoplasia\n* Hypersensitivity to bisphosphonates, or previous use of the medication\n* Inadequate oral condition or anticipated invasive dental procedure within the next 12 months\n* Alkaline phosphatase \\\u003C 98 IU\u002FL or \\> 180 IU\u002FL\\*\n* PTH \\\u003C 130 pg\u002FmL and \\> 585 pg\u002FmL\\*\n* Severe liver disease\n* Severe heart disease\n* Clinical suspiction of osteomalacia\n* Cytopenias, defined as: platelets \\\u003C 120,000\u002Fmm³, neutrophils \\\u003C 3,000\u002Fmm³, lymphocytes \\\u003C 1,000\u002Fmm³ and hematocrit \\\u003C 26% \\* Applicable only to the group of patients undergoing dialysis.",{"count":443,"type":22},24,[78],"Osteoporosis is a frequent complication of chronic kidney disease (CKD) on dialysis, with an estimated prevalence of approximately 40%. It is associated with increased fracture risk, reduced quality of life, and higher mortality. Despite available therapies, management often remains suboptimal, partly due to limited evidence on the safety and pharmacokinetics of bisphosphonates in this population. Objectives: To understand the pharmacokinetics of zoledronic acid in CKD patients on dialysis, as well as to analyze its effects on biomarkers of bone metabolism, bone mineral density (BMD), and clinical outcomes. Materials and Methods: This prospective clinical study involves 24 adult individuals, 8 with CKD-associated osteoporosis (control group; estimated glomerular filtration rate (eGFR) ≥ 35 mL\u002Fmin\u002F1.73 m²) and 16 with CKD-associated osteoporosis anuric on dialysis patients. Individuals undergoing dialysis will be assigned to receive zoledronic acid at doses of 2.5 mg or 5 mg intravenously (single dose, at the beggining of dialysis session), while patients with CKD-associated osteoporosis (control group; estimated glomerular filtration rate (eGFR) ≥ 35 mL\u002Fmin\u002F1.73 m²) will receive 5 mg, also in a single dose. Serial blood samples will be collected after infusion, during dialysis session and again up to 96h after dialysis session initiation. The dialysate will be continuously sampled in a tank and aliquots collected for further analysis. The plasma levels of zoledronic acid will be calculated from blood and dialysate samples using liquid chromatography mass spectrometry. The primary outcome is the plasma concentration-time curve of zoledronic acid during a regular dialysis session. Secondary outcomes are: (i) plasma concentration of zoledronic acid up to 96h;(ii) the total mass of zoledronic acid extracted by the dialysate; (iii) the dialytic clearance of zoledronic acid. Evaluation of bone biomarkers (e.g., PTH, alkaline phosphatase, calcium, phosphorus, CTX, and P1NP) and BMD (assessed by bone densitometry) will be performed at baseline and at 12 months. The study will be conducted at the UNICAMP Clinical Hospital, with the participation of one participating center, subject to prior approval from the respective Research Ethics Committees. All participants will be included only after signing the Informed Consent Form. Data will be anonymized and processed in accordance with the General Data Protection Law (LGPD). Expected results: To characterize the pharmacokinetic profile and establish the best dosage regimen of zoledronic acid in patients with CKD on dialysis; to observe the impact of the drug on biomarkers of bone metabolism and BMD.",[28,447,448],"Osteoporosis","Dialysis",[450,451,448,269,447],"Zoledronic acid","bisphosphonate","2026-07-31",{"date":426,"type":33},{"date":455,"type":22},"2026-08-15",{"date":457,"type":22},"2028-08-15",{"name":459,"class":91},"University of Campinas, Brazil",{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":464,"acronym":465,"eligibilityCriteria":466,"healthyVolunteers":131,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":467,"targetDuration":4,"studyType":23,"phases":469,"briefSummary":470,"conditions":471,"keywords":4,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":123},"100643819","investigating-vascular-properties-of-hemi-and-spg-signals-in-individuals-with-or-at-risk-for-chronic-kidney-disease-100643819","NCT07604922","Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease","STIMULUS-CKD","Inclusion Criteria:\n\n* Common Inclusion Criteria:\n\n  * Adults aged over 18 years, of both sexes\n  * Patients eligible for or affiliated with a social security scheme\n  * Patients who have provided written informed consent to participate in the study\n\nCommon Exclusion Criteria:\n\n* Inability to give informed consent\n* Persons under legal protection (guardianship, trusteeship, or court protection)\n* Language barrier or psychological refusal to read the information\n* Medical conditions with a life expectancy \\\u003C 1 year according to clinical judgment\n* Ongoing participation restriction due to another clinical research study\n* Pregnant women (due to physiological hemodynamic changes in blood pressure and arterial stiffness during pregnancy)\n* Cardiac arrhythmias: current atrial fibrillation or high-degree atrioventricular block\n\nExclusion Criteria:\n\n* Hypertension Group\n\n  * Inclusion: Prior diagnosis of arterial hypertension\n  * Stable cardiovascular treatment in the previous 1 month\n  * Exclusion:\n\n    * CKD with GFR \\\u003C60 mL\u002Fmin\n    * ACR \\> 30 mg\u002Fmmol\n    * Type 2 diabetes Type 2 Diabetes Group\n  * Inclusion:\n  * Prior diagnosis of type 2 diabetes\n  * Stable cardiovascular treatment in the previous 1 month\n  * Exclusion:\n\n    * CKD with GFR \\\u003C 60 mL\u002Fmin\n    * ACR \\> 30 mg\u002Fmmol Moderate CKD Group\n  * Inclusion:\n  * Moderate CKD (eGFR between 30 and 60 mL\u002Fmin) (CKD-EPI)\n  * Patients scheduled for arterial stiffness assessment as part of routine care\n  * Stable cardiovascular treatment in the previous 1 month\n  * Exclusion:\n  * No specific exclusion criteria beyond common exclusions Severe CKD Group\n  * Inclusion:\n\n    * Severe CKD (GFR \\\u003C 30 mL\u002Fmin for ≥ 2 months)\n    * Patients scheduled for arterial stiffness assessment as part of routine care\n    * Stable cardiovascular treatment the previous 1 month\n  * Exclusion: No specific exclusion criteria beyond common exclusions20 \u002F 48 C25-07\\_Protocole\\_ V1.0\\_01.12.2025 Healthy Volunteers Group\n  * Inclusion: No documented chronic disease\n  * Exclusion:\n\n    * Moderate or severe CKD (GFR \\\u003C 60 mL\u002Fmin) (CKD-EPI)\n    * Hypertension\n    * Type 2 diabetes\n    * Stable cardiovascular treatment in the previous 1 month",{"count":468,"type":22},165,[317],"This prospective, single-center clinical investigation conducted in France will evaluate two non-invasive investigational devices (HEMI and SPG-NINOX) designed to assess microcirculation in adults. The study will include 165 participants divided into five groups (33 per group): healthy volunteers, patients with hypertension without chronic kidney disease (CKD), patients with type 2 diabetes without CKD, patients with moderate CKD, and patients with severe CKD. The primary objective is to compare baseline small vessel pressure measured with the HEMI (Multi-spectral optical system for microcirculation hemodynamics) device across groups in order to identify microvascular alterations associated with cardiometabolic and renal disease. Secondary objectives include assessment of microvascular responses after post-ischemic hyperemia, evaluation of SPG-derived (Speckle plethysmography) small vessel flow and volume parameters, comparison with reference vascular measurements (including SphygmoCor and ultra-high frequency ultrasound), and evaluation of feasibility, acceptability, and measurement reproducibility. Participation is non-randomized, based on participants' pre-existing clinical condition, and study procedures are non-invasive with an expected visit duration of approximately 60 minutes.",[28,472,473],"Hypertension (HTN)","Type 2 Diabetes Mellitus (T2DM)","2026-07-30",{"date":452,"type":33},{"date":477,"type":22},"2026-09-15",{"date":479,"type":22},"2028-09-15",{"name":481,"class":482},"Institut National de la Santé Et de la Recherche Médicale, France","OTHER_GOV",{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":4,"eligibilityCriteria":489,"healthyVolunteers":12,"sex":17,"minAge":490,"maxAge":4,"enrollmentInfo":491,"targetDuration":4,"studyType":23,"phases":492,"briefSummary":494,"conditions":495,"keywords":496,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":503,"startDateStruct":504,"completionDateStruct":505,"leadSponsor":507,"locationsCount":123},"100650057","phase-4-niaoduqing-granules-in-older-adults-with-impaired-kidney-function-100650057","NCT07741292","Niaoduqing Granules in Older Adults With Impaired Kidney Function","A Study of the Clinical Benefits of Niaoduqing Granules in Older Adults With Impaired Renal Function","Inclusion Criteria:\n\n1. Participants with stage 3 to 5 chronic kidney disease who are not receiving dialysis.\n2. Age older than 60 years.\n3. The participant or a family member has sufficient literacy and is able to comply with dietary diary recording and other study-related examinations.\n4. The underlying cause of chronic kidney disease is clinically stable.\n\nExclusion Criteria:\n\n1. Malignancy, severe cardiovascular disease, osteoporosis, or severe hematopoietic system disease.\n2. Active infection, defined as C-reactive protein greater than 10 mg\u002FL, or current use of nephrotoxic medications.\n3. Limb paralysis or major limb impairment.\n4. Use of immunosuppressive therapy, including cyclosporine or tacrolimus, within the 3 months before cohort enrollment, or use of corticosteroids at a dose equivalent to more than 10 mg\u002Fday of prednisone.\n5. Severe gastrointestinal disease affecting nutrient absorption.\n6. Current participation in, or participation within the previous month in, another study related to diet or medication.\n7. Known allergy to Niaoduqing Granules.\n8. Any condition that, in the investigator's judgment, makes the participant unsuitable for the study.","61 Years",{"count":369,"type":22},[493],"PHASE4","This prospective real-world study will evaluate the clinical benefits of Niaoduqing Granules in older adults with impaired kidney function. Approximately 300 participants aged over 60 years with stage 3 to 5 chronic kidney disease who are not receiving dialysis will be enrolled at Huashan Hospital, Fudan University. The study will examine whether treatment with Niaoduqing Granules is associated with slower kidney function decline and improvements in nutrition, frailty, and other health outcomes.\n\nParticipants will receive 5 g of Niaoduqing Granules three times daily after meals for 12 months, while continuing their usual treatment for chronic diseases as directed by their physicians. Kidney function, laboratory results, nutritional status, frailty, cardiovascular and cerebrovascular events, and survival will be assessed during follow-up. Blood, urine, and stool samples will also be collected to study changes in gut microorganisms and blood metabolites that may help explain how Niaoduqing Granules affect health. Participants will be followed for up to 60 months.",[28],[497,498,499,500,501,502],"Niaoduqing Granules","Older Adults","Non-Dialysis-Dependent Chronic Kidney Disease","Renal Function Decline","Frailty","Malnutrition",{"date":426,"type":33},{"date":353,"type":33},{"date":506,"type":22},"2030-11-30",{"name":508,"class":91},"Huashan Hospital",{"id":510,"slug":511,"hasResults":12,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":4,"eligibilityCriteria":515,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":516,"targetDuration":4,"studyType":23,"phases":518,"briefSummary":519,"conditions":520,"keywords":521,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":524,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":123},"100541419","phase-3-effect-of-ketosteril-on-sarcopenia-in-patients-with-chronic-kidney-disease-100541419","NCT06329622","Effect of Ketosteril on Sarcopenia in Patients With Chronic Kidney Disease","Ketosteril Sarcopenia Chronic Kidney Disease","Inclusion Criteria:\n\n1. Meet the diagnostic criteria for CKD stage 3-4 (15 ≤eGFR\\\u003C60 ml\u002F(min\\*1.73m2)) in the 2012 Kidney Disease Improving Global Outcomes (KDIGO) guideline.\n2. Sarcopenia should be diagnosed According to the 2019 Asian Working Group for Sarcopenia (AWGS) diagnostic criteria for sarcopenia: ① Muscle strength: grip strength (\\\u003C 28 kg for males, \\\u003C 18 kg for females); ② Physical function: is assessed by walking speed over 6 m (\\\u003C 1.0 m\u002Fs) or five-repetition sit-to-stand test (5STS) (≥ 12 s) or recommended short physical performance battery (SPPB) (≤ 9); ③ Artificial skeletal muscle (ASM) of extremities: Bioelectrical impedance analyzer (BIA) (\\\u003C 7.0 kg\u002Fm2 for males and \\\u003C 5.7 kg\u002Fm2 for females). On the basis of meeting criteria ③, sarcopenia can be diagnosed if at least one of the first two items is met.\n3. Patient can walk normally.\n4. Provide the written informed consent.\n\nExclusion Criteria:\n\n1. Patients with diabetes.\n2. Obese\u002Foverweight patients (body mass index\\>25 kg\u002Fm2)\n3. Had previously received renal replacement therapy (including kidney transplantation, hemodialysis, peritoneal dialysis).\n4. Patients with new cardiovascular events, uncontrolled acute or chronic cardiac failure within 3 months.\n5. Patients with acute infection (C-reactive protein\\>10 mg\u002FL) or acute exacerbation of chronic diseases that is not under control within 3 months.\n6. Patients with cerebrovascular events, severe liver disease, malignant tumor and multiple organ failure.\n7. Patients with osteoarthritis, metabolic bone disease, osteonecrosis of the femoral head, hemiplegia and cognitive dysfunction.\n8. Patients with hypercalcemia and amino acid metabolism disorder.\n9. Those who are allergic to the active ingredients or other excipients of the Ketosteril.\n10. Patients with poor compliance, unable to follow the study requirements for diet control.\n11. Participated in other interventional clinical trials within 30 days before this study.",{"count":517,"type":22},58,[25],"The investigators hypothesize that Ketosteril can improve sarcopenia in patients with renal disease without increasing the burden on the kidneys and causing deterioration of renal function. Therefore, this study intends to take patients with CKD stage 3-4 and sarcopenia as the research object, give Ketosteril intervention or not to patients on the base of low-protein diet, and clarify the clinical benefits of Ketosteril prescription for improving sarcopenia in patients with CKD.",[28,294],[321,522],"sarcopenia","2026-07-25",{"date":198,"type":33},{"date":526,"type":33},"2024-05-01",{"date":528,"type":22},"2028-06-30",{"name":508,"class":91},{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":536,"eligibilityCriteria":537,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":538,"enrollmentInfo":539,"targetDuration":4,"studyType":23,"phases":541,"briefSummary":542,"conditions":543,"keywords":547,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":563},"100604778","pivotal-study-of-the-velocity-pavf-system-100604778","NCT07153939","Pivotal Study of the Velocity™ pAVF System","Multicenter Pivotal Study of the Velocity™ Percutaneous Arterio-Venous Fistula System","VENOS-3","Inclusion Criteria:\n\n1. ESRD requiring hemodialysis access or CKD with anticipated need for hemodialysis within 6 months\n2. Cubital perforating vein diameter ⩾ 2.0 and ⩽ 5.0 mm\n3. Proximal radial artery diameter ⩾ 2.0 and ⩽ 4.0 mm\n4. Age \\> 18 years and \\\u003C 80 years\n5. Willing and competent to give written informed consent\n6. Willing and able to complete all study assessments and follow-up requirements\n\nExclusion Criteria:\n\n1. Study extremity systolic blood pressure \\\u003C 100mmHg\n2. Subjects with occlusion of the ulnar or radial artery at any level or an abnormal Allen's test\n3. Subjects with a previous ipsilateral arterio-venous graft or previous ipsilateral upper arm AVF.\n4. Distance between Cubital Perforating Vein and Proximal Radial Artery \\> 3.0 mm\n5. Cephalic vein diameter \\\u003C 2.5 mm at any point from the CPV to the axillary vein\n6. Central venous occlusion ipsilateral of the study extremity\n7. Severe calcification of the radial artery that significantly impairs ultrasound visualization (e.g., acoustic shadowing) and thus precludes safe or accurate device deployment.\n8. Evidence of active systemic infections or localized to the procedure access site within the past 7 days\n9. History or evidence of severe cardiac disease (NYHA Functional Class III or IV), myocardial infarction within six months prior to study entry, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina\n10. Any contraindication to antiplatelet therapy\n11. Currently being treated with another investigational device or drug\n12. Known adverse effects to sedation and\u002For anesthesia which cannot be adequately pre-medicated\n13. Uncontrolled or poorly controlled diabetes defined as a HbA1C \\> 10%\n14. Known hypercoagulable condition, bleeding diathesis or coagulation disorder\n15. Lymphedema of the study extremity\n16. Scheduled kidney transplant within 6 months of enrollment\n17. Peripheral white blood cell count \\\u003C 1,500 cells\u002FμL or \\> 13,000 cells\u002FμL and neutrophil \\> 80%\n18. Platelet count \\\u003C 75,000 cells\u002F μL\n19. Current diagnosis of carcinoma (unless in remission \\> 1 year)\n20. Pregnant or currently breast feeding\n21. Allergies to nickel or nickel titanium alloy (NiTi) or any of the components of the Velocity Implant or Delivery System\n22. Any other medical condition that in the opinion of the investigator would put the welfare of the subject at risk or confound interpretation of the study data\n23. Investigator determines that vascular anatomy at intended index procedure site is inappropriate for use of investigational device prior to attempting needle access.","80 Years",{"count":540,"type":22},126,[317],"This study will evaluate the Velocity Percutaneous Arteriovenous Fistula (pAVF) System, a new minimally invasive method for creating dialysis access. People with kidney failure often require dialysis, which depends on having a reliable arteriovenous fistula (AVF). Traditionally, AVFs are created with surgery, but surgery can involve incisions, longer recovery, and sometimes additional procedures before the AVF can be used.\n\nThe Velocity System is designed to create an AVF through a small puncture in the skin using a catheter-based approach, without open surgery. This pivotal study will assess how safe the procedure is and how well it works for patients who need dialysis.\n\nThe study will take place at multiple centers in the United States and will enroll adults with kidney failure who are candidates for fistula creation. Participants will undergo the Velocity procedure and then be followed closely with exams, ultrasounds, and dialysis assessments for up to five years.\n\nTaking part is voluntary. Patients may benefit from a less invasive approach to dialysis access, but the main goal is to collect information that could improve future care for people with kidney failure.",[28,544,545,546],"Hemodialysis Access","Arteriovenous Fistula","End Stage Renal Disease (ESRD)",[548,549,550,551,545,552,536,553],"percutaneous AVF","pAVF","endovascular AVF","endoAVF","AVF","VENOS3","2026-07-24",{"date":556,"type":33},"2026-07-27",{"date":558,"type":33},"2025-10-21",{"date":560,"type":22},"2030-09",{"name":562,"class":40},"Venova Medical",12,{"id":565,"slug":566,"hasResults":12,"nctId":567,"briefTitle":568,"officialTitle":569,"acronym":570,"eligibilityCriteria":571,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":572,"enrollmentInfo":573,"targetDuration":4,"studyType":23,"phases":575,"briefSummary":576,"conditions":577,"keywords":578,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":583,"startDateStruct":584,"completionDateStruct":586,"leadSponsor":588,"locationsCount":123},"100648931","evaluation-of-the-effect-of-a-daily-dose-of-wakame-seaweed-on-reducing-circulating-concentrations-of-advanced-glycation-end-products-in-patients-with-stage-iii-chronic-kidney-disease-100648931","NCT07729683","Evaluation of the Effect of a Daily Dose of Wakame Seaweed on Reducing Circulating Concentrations of Advanced Glycation End Products in Patients With Stage III Chronic Kidney Disease","Evaluation of the Effect of a Daily Dose of Wakame (Undaria Pinnatifida) on Reducing Circulating Concentrations of Advanced Glycation End Products (AGEs: Methylglyoxal) in Patients With Stage III Chronic Kidney Disease","Ckd-WEED","Inclusion Criteria:\n\n* Adult patients not under legal protection\n* Patients aged ≥ 18 and \\\u003C 90 years\n* Patients with stage IIIA-B chronic kidney disease (CKD) (estimated GFR by CKD-EPI ≥ 30 mL\u002Fmin and \\\u003C 60 mL\u002Fmin)\n* Patients receiving optimized nephroprotective treatment (ACE inhibitors, SGLT2 inhibitors)\n* Patients who have signed the informed consent form\n* Patients not participating in another clinical study\n* Patients affiliated with or benefiting from a social security scheme\n\nExclusion Criteria:\n\n* Adult patients under legal protection\n* Patients under 18 years old or over 90 years old\n* Patients with uncontrolled thyroid disorders\n* Patients with decompensated heart failure\n* Patients consuming other dietary supplements containing seaweed or iodine (e.g., multivitamins)\n* Pregnant or breastfeeding women\n* Patients with acute kidney injury\n* Patients who decline to participate in the study","90 Years",{"count":574,"type":22},30,[317],"Persistent glomerular hyperfiltration is a characteristic feature of the early stages of kidney disease and represents a factor in the progression of chronic kidney disease (CKD). In this context, the benefit of low-protein diets (less than 0.8g\u002Fkg\u002Fday) has been demonstrated in slowing the progression of CKD, although the underlying pathophysiological mechanisms remain unclear.\n\nSome studies suggest that the effects of protein on renal hemodynamics are primarily linked to the quality of the protein, particularly the amount of AGEs (Advanced Glycation End Products) consumed.\n\nRecently, edible seaweeds have gained popularity in Western countries due to their anti-inflammatory, anti-diabetic, and antihypertensive properties. These seaweeds are also associated with the above-average longevity of certain Asian populations who consume them daily. Wakame seaweed (Undaria pinnatifida), which is locally harvested along the French Atlantic coast, has shown promising biological properties, notably antihypertensive and anti-diabetic effects. It has also been recently demonstrated that fucoxanthin, a compound found in high concentrations in wakame, possesses strong anti-AGE activity.\n\nDietary modifications are essential for nephroprotection, but they are often difficult to implement. This highlights the need to develop approaches that are both acceptable on a daily basis and sustainable in the long term for patients.\n\nA Michelin-starred chef, known for regularly incorporating seaweed into his cuisine, is a sponsor of the project and has validated a set of adapted recipes that will be offered to participants to accompany the daily wakame supplementation.\n\nThe investigator's hypothesis is that a daily dose (5 grams of French wakame, dehydrated at low temperature and in flake form), equivalent to the average daily intake in Japan, could reduce circulating AGE levels in patients with stage III CKD. This would provide an additional protective effect when combined with the standard low-protein diet, helping to slow the progression of CKD over the long term.",[28],[579,580,581,582],"Advanced Glycation End Products","AGEs","Chronic kidney disease (CKD)","Wakame seaweed",{"date":556,"type":33},{"date":585,"type":33},"2026-01-27",{"date":587,"type":22},"2027-10",{"name":589,"class":91},"Groupe Hospitalier de la Rochelle Ré Aunis",{"id":591,"slug":592,"hasResults":12,"nctId":593,"briefTitle":594,"officialTitle":595,"acronym":4,"eligibilityCriteria":596,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":101,"enrollmentInfo":597,"targetDuration":4,"studyType":23,"phases":599,"briefSummary":600,"conditions":601,"keywords":605,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":611,"startDateStruct":612,"completionDateStruct":614,"leadSponsor":616,"locationsCount":92},"100617337","the-ntu-jo-smart-study-100617337","NCT07317310","The NTU JO-SMART Study","Effects of the NTU-JO Smart Program for People With Knee Osteoarthritis and Obesity: a Multicenter Pragmatic Randomized Controlled Trial","Inclusion Criteria:\n\n* Age: 18 to 75 years.\n* Obesity status: body mass index (BMI) ≥ 27 kg\u002Fm², consistent with the obesity definition defined by the Health Promotion Administration, Ministry of Health and Welfare, Taiwan.\n* Diagnosis of KOA in at least one knee according to the American College of Rheumatology (ACR) criteria, with a Kellgren-Lawrence (KL) grade of 1, 2, or 3.\n* Symptomatic disease: defined as a WOMAC pain subscale score (range 0-20) greater than 4 at screening.\n* Sedentary lifestyle: defined as less than 30 minutes of physical activity per week for the past 6 months.\n* Informed consent: willing and able to provide written informed consent and comply with all longitudinal study procedures.\n* Comorbid status: participants may be included regardless of a baseline diagnosis of T2D or CKD. Stratified randomization and subgroup analyses will be conducted based on these baseline conditions.\n\nExclusion Criteria:\n\n* KL grade 4 KOA in either knee.\n* Diagnosis of inflammatory arthritis, such as rheumatoid arthritis or psoriatic arthritis.\n* Knee arthroscopy within the past 3 months or previous surgical history of TKA.\n* Recent receipt of intra-articular injections (e.g., corticosteroids, hyaluronic acid) within the past 3 months.\n* Documented history of osteoporotic fracture in hospital or cloud-based medical records.\n* Type 1 diabetes.\n* Presence of conditions precluding safe participation in an exercise program, such as unstable cardiovascular disease or severe neurological disorders.\n* Participation in another interventional clinical trial within the past 3 months.\n* Engagement in dietary regimens likely to cause significant weight change (e.g., intermittent fasting, such as the 16:8 time-restricted eating) within 1 month prior to trial initiation.\n* Use of any FDA-approved weight-loss medications (e.g., semaglutide, tirzepatide) within 3 months prior to trial initiation.\n* History of any form of surgical treatment for weight loss.\n* Current use of lithium or antipsychotics at a dose equivalent to olanzapine \\>20 mg\u002Fday.\n* Pregnant or breastfeeding women, or women of childbearing potential without adequate contraception.\n* Current malignancy (within the validity period of a catastrophic illness certificate), or any other clinical condition deemed unsuitable for participation by the investigator (investigator discretion).\n* Inability to use smart devices or telecommunication tools due to severe visual\u002Fhearing impairment or lack of internet access.",{"count":598,"type":22},312,[317],"This study recruits patients with coexisting obesity and knee osteoarthritis (KOA) to implement the NTU-JO Smart Program, an innovative intervention integrating AI-assisted community-based exercise with continuous glucose monitoring (CGM). The primary objective is to investigate whether this intervention can improve glycemic control in this comorbid population. Other outcome measures include the risk of total knee arthroplasty (TKA), body weight changes, pain intensity scores, bone mineral density (BMD), cognitive function, as well as the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Patient-Reported Outcomes Measurement Information System (PROMIS) scores, which reflect the patients' overall functional status. The project also sought to explore the long-term association of the NTU-JO Smart Program with the development of type 2 diabetes (T2D) and major renal events, thereby facilitating patient-centered early treatment.",[602,603,604,28],"Knee Osteoarthristis","Diabetes (DM)","Obesity & Overweight",[167,217,606,607,608,609],"Knee osteoarthristis","obesity","Exercise","continuous glucose monitoring","2026-07-22",{"date":554,"type":33},{"date":613,"type":22},"2026-08-01",{"date":615,"type":22},"2035-07-31",{"name":617,"class":91},"National Taiwan University Hospital",{"id":619,"slug":620,"hasResults":12,"nctId":621,"briefTitle":622,"officialTitle":622,"acronym":4,"eligibilityCriteria":623,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":624,"targetDuration":4,"studyType":23,"phases":625,"briefSummary":626,"conditions":627,"keywords":630,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":635,"startDateStruct":636,"completionDateStruct":638,"leadSponsor":640,"locationsCount":123},"100583503","staged-kidney-transplantation-during-combined-heartkidney-transplantation-100583503","NCT06877169","Staged Kidney Transplantation During Combined Heart\u002FKidney Transplantation","Inclusion Criteria:\n\n* Adult patients (18 years or older) undergoing combined heart and kidney transplantation at Cedars-Sinai Medical Center.\n\nExclusion Criteria:\n\n* Patients who undergo simultaneous heart\u002Fkidney transplantation in a single operative event due to medical necessity will be excluded.\n* Patients with medical records flagged as \"break-the-glass\" or \"research opt-out\" within the center's electronic health record.",{"count":289,"type":22},[317],"The primary purpose of this study is to evaluate the safety and efficacy of ex vivo machine perfusion with staged implantation of kidney allografts during combined heart\u002Fkidney transplantation.",[628,28,629],"Heart Failure","End-stage Kidney Disease",[631,632,633,634],"combined heart and kidney transplant","simultaneous heart and kidney transplant","hypothermic oxygenated machine perfusion","organ preservation",{"date":554,"type":33},{"date":637,"type":33},"2025-04-07",{"date":639,"type":22},"2035-02-28",{"name":641,"class":91},"Cedars-Sinai Medical Center",{"id":643,"slug":644,"hasResults":12,"nctId":645,"briefTitle":646,"officialTitle":647,"acronym":4,"eligibilityCriteria":648,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":649,"targetDuration":4,"studyType":23,"phases":650,"briefSummary":651,"conditions":652,"keywords":654,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":657,"lastUpdatePostDateStruct":658,"startDateStruct":659,"completionDateStruct":661,"leadSponsor":663,"locationsCount":665},"100648807","phase-2-a-study-of-luspatercept-in-people-with-anemia-100648807","NCT07725497","A Study of Luspatercept in People With Anemia","A Multicenter Phase 2 Study of Luspatercept in Patients With Anemia Due to Chronic Kidney Disease","Inclusion Criteria:\n\nDocumentation of Anemia due to CKD\n\n* Patients must have a Hb ≤ 9.5 g\u002FdL on two separate occasions within 4 weeks prior to enrollment.\n* Do not anticipate red cell transfusion within the following 4 weeks and no history of red cell transfusion in three weeks prior to enrollment.\n* Ferritin ≥100 ng\u002FmL and iron transferrin saturation (TSAT) ≥ 20%.\n* Serum folate \\> 4 ng\u002FmL\n* Serum vitamin B12 \\> 250 pg\u002FmL\n* Patients may have received iron, B12 and folic acid repletion if initiated \\> 6 weeks prior to enrollment. Patients who are already on iron, B12 and folic acid repletion can continue throughout the trial.\n* TSH, T4 within institutional normal limits. Documentation of Chronic Kidney Disease\n* Chronic kidney disease defined as a GFR between 30-60 mL\u002Fmin\u002F1.73m2 for ≥ 3 months calculated by the 2021 CKD-EPI creatinine equation for eGFR, the 2021 CKD-EPI creatinine-cystatin C equation, or creatinine clearance measured by a 24-hour urine collection.\n\nPrior Treatment with Erythrocyte Stimulating Agents (ESA)\n\n* Eligible patients will not have had recent (within past 3 weeks) erythrocyte stimulating agents (ESA) prior to enrollment unless they are hyporesponsive to ESA therapy.\n* Patients are eligible if they are either hyporesponsive to ESA therapy or unwilling to accept ESAs. defined by the Kidney Disease Outcomes Quality Initiative (KDOQI) as the inability to achieve\u002Fmaintain a desired hemoglobin (herein defined as a hemoglobin of \\> 9.0 g\u002FdL) using a maximum dose of erythropoietin (450 units\u002Fkg\u002Fweek IV or 300 units\u002Fkg\u002Fweek SQ or the darbepoetin equivalent using the conversion of 45,000 units\u002Fweek of epoetin = 100 mcg\u002Fweek of darbepoetin).\n* Age ≥ 18\n* ECOG Performance Status of ≤ 2\n* Not Pregnant and Not Nursing Required Organ Function\n* Adequate hematologic function defined as follows:\n* Absolute neutrophil count (ANC) ≥ 1,000 cells\u002Fmm3\n* Platelets ≥ 75,000 cells\u002Fmm3\n* Adequate hepatic function defined as follows:\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x ULN may be enrolled)\n* AST and ALT ≤3 x institutional ULN\n* Comorbid Conditions\n* Patients with a history of a solid organ malignancy can be included if they have been in remission for at least 12 months.\n\nExclusion Criteria:\n\n* Evidence of recent (within previous 4 weeks) bleeding including gastrointestinal to explain anemia.\n* Evidence of hemolysis (LDH ≥ 2 x ULN and haptoglobin below lower limit of normal)\n* Known diagnosis of myelodysplastic syndrome or any known hematologic malignancy \\[not including monoclonal of undetermined significance (MGUS) or monoclonal b-cell lymphocytosis (MBL)\\] not in remission\n* GFR \\\u003C 30 mL\u002Fmin\u002F1.73m2 or on dialysis (no available data for luspatercept on HD)\n* Acute kidney injury ( ≤ 3 months)\n* Uncontrolled hypertension: repeated elevations of SBP ≥ 150 mmHg and\u002For DBP ≥ 100 mmHg despite adequate treatment\n* Known hemoglobinopathy.\n* Known inherited or acquired thrombophilia.\n* History of venous thromboembolism within past 2 years\n* Cerebral vascular accident within past 2 years\n* Recent (within 2 years) myocardial infarction\n* Allergy to luspatercept components",{"count":574,"type":22},[79],"The researchers are doing this study to test whether luspatercept works to improve hemoglobin levels in people with anemia caused by chronic kidney disease (CKD). The researchers will also test whether luspatercept is a safe treatment that causes few or mild side effects in participants.",[653,28],"Anemia",[655,656],"Luspatercept","26-194","2026-07-21",{"date":554,"type":33},{"date":660,"type":33},"2026-07-20",{"date":662,"type":22},"2029-07",{"name":664,"class":91},"Memorial Sloan Kettering Cancer Center",7]