[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"renal-impairment\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:renal-impairment":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,44,67,86,111,137,163,195,220,241],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100619716","phase-1-a-clinical-trial-of-mk-2828-in-people-with-kidney-disease-mk-2828-006-100619716",false,"NCT07348237","A Clinical Trial of MK-2828 in People With Kidney Disease (MK-2828-006)","An Open-Label, Single-Dose Clinical Study to Evaluate the Pharmacokinetics of MK-2828 in Participants With Renal Impairment","The main inclusion criteria include but are not limited to the following:\n\n* Is in generally good health, with the exception of renal impairment participants. Participants with stable, chronic medical or psychiatric conditions may be included at the discretion of the investigator and the Sponsor.\n\nSevere Renal Impairment Participants:\n\n* Has an estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin), but is not on hemodialysis (HD)\n\nESRD on HD Participants:\n\n* Has ESRD maintained on stable outpatient regimen of intermittent high-flux HD at a healthcare center for \\> 3 months prior to study entry\n\nThe main exclusion criteria include but are not limited to the following:\n\nRenal Impairment Participants:\n\n* History of any illness, other than renal impairment, that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study.\n\nHealthy Matched Control Participants:\n\n* History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases. Participants with a remote history of uncomplicated medical events (eg, uncomplicated kidney stones, as defined as spontaneous passage and no recurrence in the last 5 years, or childhood asthma) may be enrolled in the study at the discretion of the investigator.",true,"ALL","24 Years","85 Years",{"count":21,"type":22},24,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The goal of this trial is to measure what happens to 1 or 2 doses of MK-2828 in a person's body over time (pharmacokinetic or PK trial). Researchers want to learn if the PK of people with certain types of kidney disease is similar to the PK of healthy people.",[28,29,30],"Chronic Kidney Failure","End-Stage Renal Disease","Renal Impairment","RECRUITING","2026-08-12",{"date":34,"type":35},"2026-08-14","ACTUAL",{"date":37,"type":35},"2026-03-02",{"date":39,"type":22},"2026-09-21",{"name":41,"class":42},"Merck Sharp & Dohme LLC","INDUSTRY",3,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":19,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100651259","phase-1-renal-impairment-pharmacokinetics-pk-trial-of-afabicin-100651259","NCT07758608","Renal Impairment Pharmacokinetics (PK) Trial of Afabicin","An Open-Label, Adaptive Single-Dose Trial to Investigate the Effect of Renal Impairment on the Pharmacokinetics of Afabicin","Inclusion Criteria:\n\n1. Signed and dated written informed consent obtained before undertaking any trial-specific procedures.\n2. Body Mass Index (BMI): 18.5 to 35.0 kilograms per square meter (kg\u002Fm\\^2), inclusive, at screening.\n3. Nonsmoker (confirmed by urine cotinine \\\u003C500 nanograms per milliliter (ng\u002FmL)) and have not used nicotine or nicotine containing products for the last month before screening.\n4. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other trial procedures.\n5. Stable renal function. Renal function must be considered stable by the Investigator. The screening eGFR, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 2021 formula and adjusted for body surface area (multiplied by individual BSA\u002F1.73 m\\^2), will be used for group allocation:\n\n   1. For participants with normal renal function: eGFR ≥90 mL\u002Fmin\n   2. For participants with mild renal impairment: eGFR ≥60 to \\\u003C90 mL\u002Fmin\n   3. For participants with moderate renal impairment: eGFR ≥30 to \\\u003C60 mL\u002Fmin\n   4. For participants with severe renal impairment and kidney failure not receiving dialysis: eGFR \\\u003C30 mL\u002Fmin\n6. Confirmation of renal function prior to dosing. Renal function stability must be confirmed on Day -1. The eGFR determined on Day -1, obtained at least 3 days apart from screening, must not deviate by more than 25 percent (%) from the eGFR value obtained at screening.\n\nExclusion Criteria:\n\n1. Any clinically significant symptoms of an infectious illness (bacterial, viral or parasitic) within 2 weeks prior to first dosing or a history of recurrent infections (≥3 infections requiring medical intervention in the 6 months prior to ICF signature).\n2. History of chronic drug or alcohol abuse in the last 4 years.\n3. A positive result in the alcohol and\u002For urine drug abuse evaluations at screening or admission on Day -1, unless the result is attributable to a prescribed medication used to treat comorbidities associated with chronic kidney disease or another stable condition.\n4. History of investigational medication use within 3 months or 5 half-lives of the drug (whichever is longer) prior to administration the trial drug.\n5. Blood loss or donation of blood over 500 milliliter (mL) within 3 months prior to screening.\n6. Uncontrolled hypertension, defined as systolic blood pressure greater than (\\>)160 millimeters of mercury (mm Hg) or diastolic blood pressure \\>100 mm Hg on average of 3 measurements at screening. Screening measurements should be conducted with participants on baseline anti-hypertensive regimen.\n7. History and\u002For presence of any clinically significant disease or disorder, such as cardiovascular, pulmonary, renal (for participants with normal renal function), hepatic, neurological, gastrointestinal, endocrine, psychiatric or mental disease or disorder, or mental or legal incapacitation, which, in the opinion of the Investigator, may either put the participant at risk due to participation in the trial, influence the results of the trial, or influence the participant's ability to participate in the trial.\n8. History of uric acid stone disease in the last 5 years.\n9. History of chronic pancreatitis or idiopathic acute pancreatitis.\n10. Participants with renal transplant or renal carcinoma (participants with a history of renal carcinoma could be included if cancer free for \\>10 years).\n11. A potassium concentration \\>6.1 millimoles per liter (mmol\u002FL) at screening or Day -1.\n12. Plasma albumin \\\u003C3.0 grams per deciliter (g\u002FdL) and\u002For proteinuria \\>3.5 grams per day (g\u002Fday) at screening.\n13. A history of nephrotic syndrome.\n\nNote: Other protocol-specified inclusion\u002Fexclusion criteria may apply.","18 Years",{"count":53,"type":22},60,[25],"The primary purpose of this study is to assess the effect of renal impairment on the PK of afabicin desphosphono after a single oral 80 milligrams (mg) or intravenous (IV) 55 mg dose of afabicin.",[30],"NOT_YET_RECRUITING","2026-08-06",{"date":60,"type":35},"2026-08-11",{"date":62,"type":22},"2026-08",{"date":64,"type":22},"2028-02",{"name":66,"class":42},"Debiopharm International SA",{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":16,"sex":17,"minAge":51,"maxAge":19,"enrollmentInfo":74,"targetDuration":4,"studyType":23,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":82,"leadSponsor":84,"locationsCount":4},"100650056","phase-1-a-study-investigating-the-safety-of-ro7795081-and-how-the-body-processes-ro7795081-in-people-with-normal-or-decreased-kidney-functions-100650056","NCT07741604","A Study Investigating the Safety of RO7795081 and How the Body Processes RO7795081 in People With Normal or Decreased Kidney Functions","A Two-part, Non-randomized, Open-label, Parallel-group Study to Assess the Effect of Renal Impairment on the Pharmacokinetics and Safety of RO7795081 Following a Single Oral Dose of RO7795081","Inclusion Criteria:\n\n* Ability and willingness to comply with all aspects of the protocol including completion of assessments for the duration of the study\n* Estimated Glomerular Filtration Rate (eGFR) calculated using the Body Surface Area (BSA)-adjusted Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation\n* Participants with mild, moderate, or severe renal impairment\u002Fkidney failure and stable renal function\n* Participants with normal renal function matched to participants with renal impairment\n\nExclusion Criteria:\n\n* Any condition or disease detected during the medical interview\u002Fphysical examination that would render the participant unsuitable for the study, place the participant at undue risk, or interfere with the ability of the participant to complete the study in the opinion of the Investigator\n* History or evidence of any medical condition other than renal impairment capable of significantly altering the absorption, metabolism, or elimination of drugs\n* Surgical history of the gastrointestinal (GI) tract affecting gastric motility or altering the GI tract (with the exception of uncomplicated appendectomy and cholecystectomy)\n* History of malignancy in the past 5 years, except for fully treated local basal carcinoma, or fully treated carcinoma in situ of cervix\n* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2\n* History of cardiovascular, neurologic, psychiatric, or infectious disease\n* History of hypersensitivity to any of the excipients in Glucagon-like Peptide-1 (GLP-1) agonists\n* Bipolar disorder, schizophrenia, or any other serious psychiatric condition\n* Type 1 diabetes or poorly controlled Type 2 diabetes\n* Current or recent participation in another clinical study\n* Pregnancy or breastfeeding\n* Positive Human Immunodeficiency Virus (HIV), hepatitis B, hepatitis C, or tuberculosis test\n* History of alcohol or substance abuse",{"count":53,"type":22},[25],"The purpose of this study is to assess the effect of renal impairment on the pharmacokinetics (PK) and safety of RO7795081, following a single oral dose in participants with renal impairment compared with participants with normal renal function.\n\nIn Part 1, participants with normal renal function and participants with severe renal impairment or kidney failure not receiving dialysis will receive RO7795081. Part 2 is optional and will be conducted based on the results of Part 1. If Part 2 is implemented, additional participants with normal renal function and participants with mild or moderate renal impairment may be enrolled to receive RO7795081.",[30],"2026-07-29",{"date":80,"type":35},"2026-08-03",{"date":80,"type":22},{"date":83,"type":22},"2028-02-01",{"name":85,"class":42},"Hoffmann-La Roche",{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":16,"sex":17,"minAge":51,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":23,"phases":97,"briefSummary":98,"conditions":99,"keywords":100,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100647823","phase-1-the-study-is-to-investigate-d-2570-in-participants-with-different-levels-of-kidney-function-100647823","NCT07715175","The Study is to Investigate D-2570 in Participants With Different Levels of Kidney Function.","A Study to Evaluate the Pharmacokinetics of D-2570 in Participants With Renal Impairment Compared to Those With Normal Renal Function","D2570-107","Inclusion Criteria:\n\n* Voluntarily participate in this study after adequate informed consent, sign the written informed consent form, and agree to comply with all procedures specified in the study protocol;\n* Aged 18 to 70 years (inclusive). Age matching will be conducted between the normal renal function group and the matched renal impairment group with a mean difference within ±10 years;\n* Male and female participants are eligible. Gender matching will be performed between the normal renal function group and the matched renal impairment group with a difference of no more than 1 subject;\n* Male participants weigh no less than 50 kg, and female participants weigh no less than 45 kg. Body mass index (BMI) = weight (kg) \u002F height squared (m²), ranging from 19 to 30 kg\u002Fm² (inclusive). Weight matching will be conducted between the normal renal function group and the matched renal impairment group with a mean difference within ±10 kg;\n\nExclusion Criteria:\n\n* Allergic constitution (e.g., allergy to pollen, two or more types of drugs\u002Ffoods), or history of atopic diseases such as asthma and urticaria, or known hypersensitivity to the study drug or its excipients;\n* Positive T-SPOT result at screening. Combined with clinical signs and chest posteroanterior X-ray findings, the participant is judged by the investigator to have active pulmonary tuberculosis;","70 Years",{"count":96,"type":22},40,[25],"This study is divided two parts into: Part A and Part B. Part A will recruit 24 research participants, and Part B will recruit 16 research participants.",[30],[30],"2026-07-21",{"date":103,"type":35},"2026-07-23",{"date":105,"type":22},"2026-08-09",{"date":107,"type":22},"2026-11-21",{"name":109,"class":42},"InventisBio Co., Ltd",1,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":19,"enrollmentInfo":118,"targetDuration":4,"studyType":23,"phases":120,"briefSummary":121,"conditions":122,"keywords":123,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":136},"100635954","phase-1-a-study-to-assess-the-safety-and-pharmacokinetics-of-incb123667-when-administered-orally-to-adult-participants-with-severe-renal-impairment-or-end-stage-renal-disease-100635954","NCT07559396","A Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Severe Renal Impairment or End Stage Renal Disease","A Phase 1, Open-Label Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Severe Renal Impairment or End Stage Renal Disease","Inclusion Criteria:\n\n* Aged 18 to 85 years, inclusive, at the time of signing the ICF.\n* Severe renal impairment or ESRD based on CKD-EPI.\n* Body mass index of 18.0 to 43.0 kg\u002Fm2 (inclusive).\n* Willingness to avoid pregnancy or fathering children.\n\nExclusion Criteria:\n\n* Participants who have a current, functioning organ transplant or are on the national transplant list and expected to receive a transplant within 3 months.\n* Participants with laboratory values outside the accepted range for participants with severe renal impairment or ESRD at screening. Participants with out-of-range values will be assessed by the investigator or designee for eligibility.\n* Tobacco or nicotine-containing product use of \\> 10 cigarettes per day within 1 month before screening.\n* Participants who had a change in disease status within 30 days before screening, as documented by the participant's medical history, that is deemed clinically significant by the investigator.\n* Participants who have a history of paracentesis within 3 months prior to check-in.\n* Participants who required new medication or an increase in dose for renal disease within 3 months prior to check-in.\n* Participants who have a history of unstable diabetes mellitus (as evidenced by hemoglobin A1c ≥ 10.0%). Medications for treatment of diabetes mellitus must be reviewed and approved by the investigator and medical monitor.\n* Participants who had esophageal banding within 3 months prior to check-in or required any other treatment for gastrointestinal bleeding within 6 months prior to check-in.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.",{"count":119,"type":22},16,[25],"This study will be conducted to assess the safety and pharmacokinetics of INCB123667 when administered orally to adult participants with severe renal impairment or end stage renal disease.",[30],[124,125,126],"severe renal impairment","Kidney failure","end-stage renal disease","2026-06-12",{"date":129,"type":35},"2026-06-16",{"date":131,"type":35},"2026-05-29",{"date":133,"type":22},"2027-01-04",{"name":135,"class":42},"Incyte Corporation",2,{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":16,"sex":17,"minAge":51,"maxAge":144,"enrollmentInfo":145,"targetDuration":4,"studyType":23,"phases":147,"briefSummary":148,"conditions":149,"keywords":151,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":162},"100617187","phase-1-a-study-to-learn-how-the-body-processes-the-study-medicine-pf-07328948-in-people-with-reduced-kidney-function-100617187","NCT07315360","A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With Reduced Kidney Function","A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL-COHORT STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF PF-07328948 IN ADULTS WITH RENAL IMPAIRMENT AND HEALTHY ADULT PARTICIPANTS WITH NORMAL RENAL FUNCTION","Inclusion Criteria:\n\n* Male or female of nonchildbearing potential, between the ages of 18 and 80 years, at the screening visit.\n* BMI of 17.5 to 40.0 kg\u002Fm2 (inclusive), and a total body weight ≥45 kg (99 lbs).\n* Stable renal function, defined as ≤25% difference between 2 measurements of eGFR.\n* Group 1 only: at screening, no clinically relevant abnormalities identified by a detailed medical history, physical exam, including blood pressure and pulse rate measurement, ECG and clinical laboratory tests.\n* Group 1 only: normal renal function (mean eGFR ≥90 mL\u002Fmin) based on an average of measures from the screening visits.\n* Groups 2 \\& 3 only: good general health considered acceptable with the expected health status of individuals with chronic renal impairment.\n* Groups 2 \\& 3 only: chronic renal impairment, defined by the following mean eGFR criteria (based on screening visits):\n\n  * Severe RI: 15 ≤ mean eGFR \\\u003C30 mL\u002Fmin, not requiring hemodialysis.\n  * Moderate RI: 30 ≤ mean eGFR \\\u003C60 mL\u002Fmin.\n\nExclusion Criteria:\n\n* Any condition possibly affecting drug absorption.\n* At screening, a positive result for HIV antibodies.\n* History of renal, liver, or heart transplantation.\n* Urinary incontinence without catheterization.\n* Evidence of a prothrombotic state, including history of deep vein thrombosis, pulmonary embolism, or arterial thrombosis, or known genetic predisposition.\n* Use of an investigational product within 30 days or 5 half-lives (whichever longer).\n* A positive urine drug test or breath alcohol test at screening or admission to study clinic.\n* Group 1 only: evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.\n* Group 1 only: screening ECG demonstrating QTcF interval \\>450 ms or a QRS interval \\>120 ms.\n* Group 1 only: screening seated systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg\n* Group 2 \\& 3 only: presence of acute renal disease\n* Group 2 \\& 3 only: requiring dialysis or anticipated need for dialysis\n* Group 2 \\& 3 only: listed for solid organ transplantation\n* Groups 2 \\& 3 only: persistent severe, uncontrolled hypertension at screening, admission to study clinic, or pre-dose on Day 1.\n* Groups 2 \\& 3 only: screening ECG demonstrating a QTcF interval \\>470 ms or a QRS interval \\>120 ms.\n* Groups 2 \\& 3 only: unstable medical conditions or comorbidities that would interfere with study participation","80 Years",{"count":146,"type":22},28,[25],"The purpose of this study is to learn how the study medicine PF-07328948 is processed by the body and how safe and tolerable it is in adults with different levels of kidney function.\n\nThe study will include participants who:\n\n* Are aged 18 to 80 years.\n* Either have normal kidney function or long-term reduced kidney function (moderate or severe).\n* Have a BMI (body mass index) of 17.5 to 40 kilogram per meter squared, inclusive, and a total body weight of more than or equal to 45 kilograms or 99 pounds.\n\nAll participants will receive a single dose of PF-07328948 as a tablet taken by mouth. Participants will stay at a clinical research unit for about 6 days to receive the study medicine and undergo safety checks. Total participation lasts up to 64 days, including screening, inpatient stay, and a follow-up call.\n\nThe study is not randomized or blinded, meaning all participants and study staff know which treatment is being given. Group assignment is based on kidney function tests done during screening. The results will help researchers understand how reduced kidney function affects the way PF-07328948 works in the body.",[30,150],"Healthy",[152,30],"Healthy Volunteers","2026-05-11",{"date":155,"type":35},"2026-05-12",{"date":157,"type":35},"2026-01-28",{"date":159,"type":22},"2027-03-13",{"name":161,"class":42},"Pfizer",4,{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":17,"minAge":170,"maxAge":19,"enrollmentInfo":171,"targetDuration":4,"studyType":23,"phases":173,"briefSummary":175,"conditions":176,"keywords":179,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":194},"100594322","groundbreaking-renal-assist-device-intervening-to-enhance-cardiothoracic-surgery-outcomes-100594322","NCT07017933","Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes","GRADIENT","Inclusion Criteria:\n\nTo be eligible for participation in this study, an individual must meet all the following criteria:\n\n1. A candidate for elective or urgent on-pump coronary artery bypass grafting (CABG) and\u002For valvular surgery\n2. Male or Female age 22 to 85 years\n3. Estimated glomerular filtration rate (eGFR) 15 - 60 mL\u002Fmin\u002F1.73m2\n4. Signed and dated informed consent\n5. Female patients of childbearing potential must:\n\n   1. have negative pregnancy test at the informed consent visit,\n   2. be using previously initiated approved and effective contraception from the informed consent visit through completion of the study \\*The only recommended contraception is condoms.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Any individual, or their legally authorized representative (LAR), who does not understand the requests and risks of participating in the clinical trial or is unable to give informed consent\n2. Pregnancy or lactation\n3. Prior cardiac surgery within the last 6 months\n4. Hemodynamic instability as determined by the Principal Investigator\n5. Immunosuppression\n6. Active infections (e.g. HIV, Tbc, and all types of Hepatitis)\n7. History of polycystic kidney disease\n8. Patients with only one active kidney or one poorly functioning kidney\n9. Evidence of current kidney obstruction (e.g., Kidney stones)\n10. Evidence of current hydronephrosis\n11. Active upper and\u002For lower urinary tract infections\n12. Malignancy; oncological Surgery within 5 years or ongoing antitumoral treatment\n13. Ongoing sepsis or endocarditis\n14. Patients who have an expected 30-day postoperative mortality greater than 10% as determined by the Principal Investigator\n15. Any secondary condition as determined by the investigator that would place the subject at an increased risk or preclude the subject's full compliance with the study procedures, including injuries to the urinary organs and\u002For external genitals; or severe BPH\n16. Unexplained\u002Funexpected gross hematuria as determined by the Investigator\n17. Current or planned treatment with an investigational drug (IND), device (IDE), or other investigational intervention within 3 months prior to or during participation in this clinical trial\n18. Patients who have a current unrepaired ureteral avulsion as determined by the investigator\n19. Patients otherwise contraindicated for urological interventions, including ureter guidewire placement via bladder cystoscopy and ureteral catheterization, or otherwise contraindicated for any of the other study procedures","22 Years",{"count":172,"type":22},124,[174],"NA","Patients with renal insufficiency who undergo cardiac surgery with cardiopulmonary bypass (CPB) are at significant risk for exacerbation of renal dysfunction postoperatively. This in turn is associated with an increased risk of prolonged intensive care unit (ICU) length of stay, other comorbidities including surgical complications and 30-day mortality. Renal impairment is generally identified based on an increase in serum creatinine concentration and\u002For a certain magnitude decrease in estimated glomerular filtration rate (eGFR).\n\nThe JuxtaFlow® Renal Assist Device (RAD) is designed to sustain or enhance glomerular filtration perioperatively for patients with renal insufficiency by applying a mild controlled negative pressure to the collecting system via the renal pelvis, thereby increasing effective filtration pressure and reducing tubular pressure. This mechanism is designed to support the kidneys' functions during times of renal stress that would be associated with intrarenal edema, volume overload, increased venous pressure, and inflammatory response. By supporting renal function, specifically during the acute stress of CPB, JuxtaFlow holds promise to protect nephron function, decrease renal hypoxia, and provide multifactorial kidney function support to maintain their ability to manage future stress.",[177,30,178],"Renal Impairment After Cardiac Surgery","Acute Kidney Injury",[180,181,182,183,184],"renal assist device","RAD","renal impairment","acute kidney disease","JuxtaFlow","2026-03-17",{"date":187,"type":35},"2026-03-19",{"date":189,"type":35},"2025-07-16",{"date":191,"type":22},"2027-06-14",{"name":193,"class":42},"3ive Labs",7,{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":201,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":205,"phases":4,"briefSummary":206,"conditions":207,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":4},"100602507","desir-evaluation-of-the-pre-therapeutic-activity-of-dihydropyrimidine-deshydrogenase-dpd-in-patients-with-cancer-andor-renal-failure-100602507","NCT07124403","DESIR. Evaluation of the Pre-therapeutic Activity of Dihydropyrimidine dEShydrogenase (DPD) in Patients With Cancer and\u002For Renal Failure","Evaluation of the Pre-therapeutic Activity of Dihydropyrimidine dEShydrogenase (DPD) in Patients With Cancer and\u002For Renal Failure","DESIR","Inclusion Criteria:\n\n* Signed written informed consent\n* Affiliation to the Social Security System\n* Patients with breast or digestive cancer for whom a fluoroptmidine therapy is being considered\n* OR Patients on dialysis (GFR \\\u003C 10 ml\u002Fmin\u002F1.73 m²)\n* OR Nephrology patients with IR\n\nExclusion Criteria:\n\n* Patient with anemia \\\u003C 8.5 g\u002Fdl\n* Patient with LDH \\> 2 x \\> ULN\n* Legal incapacity or limited legal capacity\n* Subject without health insurance\n* Subject in the exclusion period of another study or in the \"national volunteer file\"",{"count":204,"type":22},742,"OBSERVATIONAL","Fluoropyrimidine drugs (5-Fluorouracil or 5-FU and its prodrug capecitabine) are a widely used in the treatment of numerous solid tumors in adults. Approximately 85% of administered 5-FU is rapidly catabolized in the liver into inactive dihydrofluorouracil (5-FUH2) by dihydro-pyrimidine dehydrogenase (DPD), leaving only a small fraction of the initial drug for an eventual transformation into cytotoxic metabolites. Impeded DPD activity is associated to an increase of cytotoxic metabolites leading to potentially very severe toxicities.\n\nTo prevent these toxicities, a pre-therapeutic measurement of plasma uracil can help assess DPD activity. Indeed, uracil is an endogenous substrate of DPD and an increase in its plasma concentration may be associated with a decrease in DPD activity. In this case, a reduction of the fluoropyrimidine dose is suggested.\n\nHowever, the investigators observed that uracilemia increased concomitantly to the severity of renal impairment. There are two possible explanations for this observation. Either the renal impairment reduces the renal elimination of uracil from blood, or DPD activity is actually impaired. In both cases, this can explain an increase in plasma uracil concentration.\n\nHowever, the impact on fluoropyrimidine dosage is different in the two cases. If the increase in uracilemia is due to renal impairment, DPD activity remains unaffected and there is no need to reduce the fluoropyrimidine dose. If DPD activity is actually impaired, a reduction in the fluoropyrimidine dose is required. In cases of renal impairment, uracilemia may therefore not be as relevant for DPD assessment as in the absence of renal impairment.\n\nTo assess if DPD activity is actually impede during renal impairment, the DPD activity of Peripheral Blood Mononuclear Cells (PBMCs) will be assessed together with uracilemia in patients with or without renal impairment. As uracilemia decreases after dialysis, the DPD activity of Peripheral Blood Mononuclear Cells (PBMCs) will also be assessed in patient before and after dialysis. Four groups of 50 patients will be studied: patients with normal renal function with hyperuracilemia (uracilemia ≥ 16 ng\u002FmL) or normal uracilemia (uracilemia \\\u003C 16 ng\u002FmL) ; and patients with renal impairment with hyperuracilemia (uracilemia ≥ 16 ng\u002FmL) or normal uracilemia (uracilemia \\\u003C 16 ng\u002FmL).\n\nThe main objective of the study is to describe the distribution of DPD activity in these four populations. The secondary objectives are to determine in normorenal patients the optimal threshold for DPD activity in non-deficient patients, allowing differentiation between deficient and non-deficient patients based on uracilemia ; and to describe in patients with impaired renal function the distribution of uracilemia with respect to the threshold previously described with the aim of verifying the relevance of uracilemia as a marker of DPD activity in such patients.",[30,208,209],"Digestive Cancers","Breast Cancer","2025-09-11",{"date":212,"type":35},"2025-09-17",{"date":214,"type":22},"2025-09",{"date":216,"type":22},"2028-09",{"name":218,"class":219},"Centre Hospitalier Universitaire de Besancon","OTHER",{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":16,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":23,"phases":229,"briefSummary":230,"conditions":231,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":194},"100570536","phase-1-pharmacokinetics-and-safety-of-rupatadine-in-participants-with-renal-impairment-compared-to-control-participants-100570536","NCT06708520","Pharmacokinetics and Safety of Rupatadine in Participants With Renal Impairment Compared to Control Participants","A Study to Investigate Pharmacokinetics and Safety of Rupatadine (10 mg) and Its Active Metabolites in Participants With Renal Impairment Compared to Matched Control Participants With Normal Renal Function","Inclusion Criteria:\n\nParticipants with normal renal function and participants with mild, moderate, or severe renal impairment who meet the following criteria will be considered eligible to participate in the clinical study:\n\n1. Participant understands the study procedures and agrees to participate in the study by giving written informed consent prior to any study-mandated procedure.\n2. Able to communicate well with the Investigator, to understand and comply with the study requirements.\n3. Willing to comply with study restrictions stated in Section 5.3 (lifestyle considerations).\n4. Male or female Caucasian subjects, between 18 and 75 years (inclusive) of age.\n5. Body mass index (BMI) is between 18 to 35 kg\u002Fm2 at Screening.\n6. Women of childbearing potential (WoCBP) must have a negative serum pregnancy test at Screening, a negative urine pregnancy test on Day -1, and agree to consistently and correctly use (from 30 days prior to dosing, during the entire study, and for at least 30 days after dosing), a highly effective method of contraception (i.e., failure rate of \\\u003C 1%) (Section 10.4 \\[Appendix 4\\]). Such methods include:\n\n   \\- Hormonal contraceptives: combined (estrogen- and progesterone-containing) contraception associated with inhibition of ovulation using oral, intravaginal, or transdermal route of administration.\n\n   Note: If a hormonal contraceptive is used, it must be initiated at least 30 days before dosing.\n   * Intrauterine device.\n   * Intrauterine hormone-releasing system.\n   * Bilateral tubal occlusion.\n   * Vasectomized partner, provided that the partner is the sole sexual partner and that the vasectomized partner has received medical assessment of the surgical success.\n   * Sexual abstinence, defined as refraining from heterosexual intercourse from 30 days prior to dosing up to at least 30 days after dosing, if this is the preferred and usual lifestyle of the subject.\n\n   WoCBP must also agree not to donate ova from the time of informed consent until 30 days after dosing\n7. Women of non-childbearing potential (WoNCBP), i.e., postmenopausal (defined as 12 consecutive months with no menses without an alternative medical cause, confirmed by a follicular stimulating hormone \\[FSH\\] test), with previous bilateral salpingectomy, bilateral salpingo-oophorectomy or hysterectomy, or with premature ovarian failure (confirmed by a specialist), XY genotype, Turner syndrome, uterine agenesis (Section 10.4 \\[Appendix 4\\]).\n8. Male participants are infertile, vasectomized (who has received medical assessment of the surgical success) or must agree to abstain from, or to use a condom, during heterosexual intercourse with a woman of childbearing potential (Section 10.4 \\[Appendix 4\\]).\n9. Male participants must agree not to donate sperm, from the time of informed consent until 30 days after dosing.\n10. Negative test results for anti-Human Immunodeficiency virus 1 and 2 antibodies (anti-HIV-1Ab and anti-HIV-2Ab), Hepatitis B surface antigen (HBsAg) and anti-Hepatitis Cvirus antibodies (anti-HCVAb).\n11. Participant agrees to refrain from consuming grapefruit juice, grapefruits, and grapefruitcontaining products from at least 7 days before the dose administration, and until the EOS Visit.\n12. Able to tolerate venipuncture\n\n    For participants with mild, moderate, or severe renal impairment, the following criteria must be met in addition:\n13. Participants with impaired renal function should be hemodynamically stable.\n14. Diagnosis of chronic (\\> 6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in renal function) renal impairment.\n15. Estimated GFR must range from:\n\n    1. 15-29 mL\u002Fmin (severe renal impairment) or\n    2. 30-59 mL\u002Fmin (moderate renal impairment) or\n    3. 60-89 mL\u002Fmin (mild renal impairment) determined by the Cockcroft-Gault equation, at the Screening Visit.\n16. Stable concomitant medications for at least 21 days prior to dosing and up to the EOS visit.\n17. Systolic blood pressure (SBP) 100-180 mmHg, diastolic blood pressure (DBP) 50-105 mmHg and pulse rate 60-100 bpm (inclusive), measured on the same arm, after 5 min in the supine position at Screening and Baseline.\n\n    For participants with normal renal function, the following criteria must be met in addition:\n18. No clinically relevant diseases captured in medical history at Screening.\n19. No clinically relevant abnormalities on physical examination at Screening and Baseline.\n20. No clinically relevant abnormalities on clinical laboratory tests at Screening.\n21. Normal renal function confirmed by estimated creatinine clearance (eCLcr) ≥ 90 mL\u002Fmin, as determined by the Cockcroft-Gault equation, at Screening.\n22. Weight within ±15% to his\u002Fher matched participant(s) enrolled in the study.\n23. Biological sex matched to his\u002Fher matched participant(s) enrolled in the study.\n24. Age within ±10 years to his\u002Fher matched participant(s) enrolled in the study.\n25. Normal BP measured on the same arm, after 5 min in the supine position at Screening and Baseline defined as:\n\n    * SBP 90-140 mmHg, DBP 60-90 mmHg, and pulse rate 60-100 bpm (inclusive) for subjects \\\u003C 65 years of age.\n    * SBP 95-160 mmHg, DBP 65-95 mmHg, and pulse rate 60-100 bpm (inclusive) for subjects ≥ 65 years of age.\n\nExclusion Criteria:\n\nParticipants with normal renal function and participants with mild, moderate, or severe renal impairment who meet one or more of the following criteria will not be considered eligible to participate in the clinical study:\n\n1. Pregnant or lactating women.\n2. Participant is unlikely to comply with the protocol requirements, instructions and study related restrictions; e.g., uncooperative attitude, inability to return for the EOS Visit and improbability of completing the clinical study.\n3. Any psychological, emotional problems, any disorders or resultant therapy that is likely to invalidate informed consent, or limit the ability of the participant to comply with the protocol requirements\n4. History of hypersensitivity to rupatadine, desloratadine or any of the excipients, or to medicinal products with similar chemical structures.\n5. History of clinically significant lactose, galactose, or fructose intolerance.\n6. Any clinically relevant acute or chronic disease which could jeopardize the safety of the participant or impact the validity of the study results.\n7. Veins unsuitable for intravenous puncture on either arm (e.g., veins that are difficult to locate, access or puncture; veins with a tendency to rupture during or after puncture).\n8. Participation in another clinical trial with an experimental drug within 2 months or 5 halflives (whichever is longer) before the Screening or in more than 2 clinical studies within 1 year prior to Screening.\n9. History or presence of clinically significant angioedema.\n10. Use of caffeine-containing beverages exceeding 800 mg per day (Section 5.3.2) at Screening.\n11. Nicotine consumption (e.g., smoking, nicotine patch, nicotine chewing gum, or electronic cigarettes) from 48 h prior to Baseline (Day -1) until discharge from confinement (Day 2).\n12. Positive test result for urine alcohol and drugs of abuse (amphetamines, benzodiazepines, cannabinoids, cocaine and opiates) at Screening and Baseline.\n\n    Note: Subjects receiving stable treatment of methadone and benzodiazepines will be allowed to be enrolled in the study even if the urine drug screen test is positive.\n13. History of heart, kidney or liver transplantation.\n14. History of stroke, chronic seizures, or major neurological disorder.\n15. Active malignant neoplastic disease or carcinoma (including leukemia, lymphoma, malignant melanoma), or myeloproliferative disease, regardless of the time since treatment.\n16. Intake of any creatine supplement from Screening to EOS.\n17. Use of any of the following 2 weeks prior to investigational medicinal product (IMP) administration or 5 half-lives, whichever is longer:\n\n    1. Enzyme-modifying drugs known to induce\u002Finhibit hepatic drug metabolism (e.g., azole antifungals \\[ketoconazole, itraconazole, fluconazole, Posaconazole, voriconazole\\], macrolide antibiotics \\[erythromycin, clarithromycin\\], diltiazem, human immunodeficiency virus (HIV) protease inhibitors, nefazodone, rifampicin, phenytoin, dexamethasone, troglitazone, and barbiturates)\n    2. CYP3A4 substrates with a narrow therapeutic index (e.g. ciclosporin, tacrolimus, sirolimus, everolimus, cisapride)\n    3. Desloratadine\n18. Clinically significant abnormalities on ECG repolarization (QTcF \\> 450 ms in males and \\>470 ms in females) at Screening.\n19. Loss of 250 mL or more blood within 3 months prior to screening.\n\n    For participants with mild, moderate or severe renal impairment the additional criteria must not be met:\n20. Fluctuating or rapidly deteriorating renal function, as indicated by strongly varying or worsening of clinical and\u002For laboratory signs of renal impairment within the Screening Period.\n21. Participants requiring dialysis.\n22. History or clinical evidence of any disease (except for renal impairment) and\u002For existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism or excretion of rupatadine, and\u002For the ability to complete the study.\n\n    For participants with normal renal function, the additional criteria must not be met:\n23. History or presence of a clinically relevant abnormality in any organ system, that is incapacitating, requires hospitalization, or in the opinion of the investigator makes the participant ineligible for enrollment in the study.\n24. History or clinical evidence of any disease and\u002For existence of any surgical or medical condition that might have interfered with the absorption, distribution, metabolism, or excretion of rupatadine (appendectomy and herniotomy are allowed, cholecystectomy is not allowed).\n25. Intake of any prescribed medication (including vaccines) including over-the-counter (OTC) medication (including herbal and dietary supplements such as St John's Wort, homeopathic preparations, vitamins and minerals) that could affect the outcome of the study as judged by the Investigator, within 14 days before the administration of the IMP or less than 5 times the half-life of that medication, whichever is longer (excluding contraceptives and hormone replacement therapy).",{"count":228,"type":22},48,[25],"The purpose of this study is to assess the PK, tolerability, and safety of rupatadine (10 mg) and its active metabolites in participants with renal impairment compared to matched control participants with normal renal function.\n\nThe study duration will be up to 40 days, including Screening, Baseline, Study Period, and EOS visit assessments.\n\nRupatadine 10 mg tablet will be administered as single dose.",[30],"2025-05-26",{"date":234,"type":35},"2025-05-28",{"date":236,"type":35},"2022-11-21",{"date":238,"type":22},"2025-07",{"name":240,"class":42},"Noucor Health S.A.",{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":205,"phases":4,"briefSummary":251,"conditions":252,"keywords":254,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":110},"100129030","development-of-a-biomarker-panel-for-the-earlier-prediction-of-acute-kidney-injury-in-patients-with-diabetes-100129030","NCT00948116","Development of a Biomarker Panel for the Earlier Prediction of Acute Kidney Injury in Patients With Diabetes","Development of a Biomarker Panel for the Earlier Prediction of Acute Kidney Injury in Patients With Diabetes Mellitus Undergoing Coronary Revascularisation","BIOMARKERS","Inclusion Criteria:\n\n1. Age \\> 18 years, known diabetes mellitus or BM on arrival consistent with probable diagnosis of diabetes, eGFR \\\u003C60 ml\u002Fmin\n2. Undergoing a PCI procedure\n3. Agrees to the additional collection of blood and urine samples as outlined above\n4. Agrees to access of their clinical records for the collection of relevant medical data\n5. No history or signs of drug abuse\n6. Able to understand and sign the written Informed Consent Form\n7. Able and willing to follow the Protocol requirements\n\nExclusion Criteria:\n\n1. Cardiogenic shock\n2. Pregnancy\n3. Patient on renal replacement therapy (haemodialysis\u002FCAPD\u002Frenal transplant)\n4. Known clinically significant infection such as HIV, Hepatitis or TB\n5. Any patient determined not able to make a reasoned, informed consent prior to the planned interventional procedure",{"count":250,"type":22},250,"Patients living with diabetes mellitus have double the risk of kidney failure compared to patients without diabetes following use of dye in many x-rays and procedures to diagnose and treat narrowing of the arteries (blood vessels) in the heart that can lead to angina or a heart attack. Heart disease is the commonest cause of death in patients with diabetes. People with diabetes are more likely to need these tests\u002Ftreatments. By identifying those at greater risk of kidney complications we may be able to make these tests\u002Ftreatments safer and offer them to more patients with diabetes.",[253,30],"Diabetes Mellitus",[255,30,178,256,257],"Diabetes mellitus","Coronary revascularisation","eGFR \u003C60ml\u002Fmin","2024-12-05",{"date":260,"type":35},"2024-12-10",{"date":262,"type":35},"2009-06-24",{"date":264,"type":22},"2025-12-31",{"name":266,"class":219},"Barts & The London NHS Trust"]