[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"end-stage-kidney-disease-eskd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:end-stage-kidney-disease-eskd":64},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,51,81,110,140,174,203,224,255,291],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100652333","liberalizing-potassium-restrictions-in-patients-receiving-hemodialysis-100652333",false,"NCT07772856","Liberalizing Potassium Restrictions in Patients Receiving Hemodialysis","Evaluating the Safety and Acceptability of a Liberalized Potassium Diet in Maintenance Hemodialysis Recipients: A Randomized Controlled Trial (LIBERATE K-HD)","LIBERATE-K HD","Inclusion Criteria\n\n1. Age ≥18 years on maintenance HD \\>3 months\n2. ≥1 serum potassium concentration \\>5.0 mmol\u002FL on routine bloodwork in past 12 months\n3. Able to provide consent\n\nExclusion Criteria\n\n1. Treatment with potassium binders within the preceding 7 days\n2. Average Urea reduction rate over the past 3 months \\\u003C65%\n3. \\>2 missed scheduled dialysis sessions in the previous month\n4. Patients receiving \\\u003C3 hemodialysis sessions per week (ex\u002F incremental dialysis)\n5. Average serum potassium concentration \\>6.0 mmol\u002FL over the past 3 months\n6. Swallowing difficulties or other GI issues preventing adequate intake\n7. Residing in an institutional setting (e.g., Long-term care homes) where meals are provided\n8. HbA1c \\>11%\n9. Unable to comply with study procedures due to cognitive impairment, language barrier or for any additional reason specified by the attending clinician","ALL","18 Years",{"count":20,"type":21},148,"ESTIMATED","INTERVENTIONAL",[24],"NA","People with end-stage kidney disease who receive hemodialysis are often told to strictly limit foods high in potassium, such as fruits, vegetables, legumes, nuts, and whole grains. This advice is intended to prevent high blood potassium levels (hyperkalemia), which can cause dangerous heart rhythm problems. However, these restrictions can make eating difficult, reduce diet quality, and lower quality of life. New research suggests that not all sources of potassium affect the body in the same way. Potassium added to highly processed foods is more easily absorbed than potassium naturally found in whole foods like fruits and vegetables. Large studies have found little evidence that eating potassium-rich whole foods increases blood potassium levels in people on dialysis. Clinical guidelines are beginning to shift, but no high-quality clinical trial has tested whether a more flexible, food-based approach is safe for people receiving hemodialysis. This study will compare two dietary approaches in 148 adults on hemodialysis: the usual low potassium diet and a \"liberalized\" potassium diet that encourages minimally processed foods while limiting highly processed foods with potassium additives. Participants will receive dietitian support and grocery assistance for 12 weeks. The investigators will closely monitor blood potassium levels to ensure safety. The investigators will also examine whether the liberalized diet is as safe as standard care, and whether it improves diet quality and quality of life. The investigators will also study factors that influence the participant's ability to follow the diet in real-world settings. If safe, this approach could reduce unnecessary food restrictions, improve diet quality, and enhance quality of life for people receiving hemodialysis, while maintaining patient safety.",[27,28,29,30,31],"End Stage Kidney Disease (ESKD)","Hemodialysis","Diet Intervention","Hyperkalemia","Potassium Bioavailability",[33,34,35,36,37],"end stage kidney disease","hemodialysis","diet intervention","hyperkalemia","potassium bioavailability","NOT_YET_RECRUITING","2026-08-13",{"date":41,"type":42},"2026-08-19","ACTUAL",{"date":44,"type":21},"2026-08-01",{"date":46,"type":21},"2030-09-01",{"name":48,"class":49},"University of Ontario Institute of Technology","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":4},"100651482","phase-1-study-of-3-monoclonal-antibodies-regn9933-regn7508-and-regn9533-in-adult-participants-with-end-stage-kidney-disease-on-hemodialysis-100651482","NCT07759167","Study of 3 Monoclonal Antibodies (REGN9933, REGN7508, and REGN9533) in Adult Participants With End-Stage Kidney Disease on Hemodialysis","A Master Protocol for a Phase 1b Double-Blind, Randomized Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9933 and REGN7508, Factor XI Monoclonal Antibodies, and REGN9533, a Factor XII Monoclonal Antibody, in Participants With End-Stage Kidney Disease on Hemodialysis","Key Inclusion Criteria:\n\n1. Has ESKD and has regular adherence receiving HD 3 times per week as described in the protocol\n2. Is receiving heparin (standard of care) anticoagulation, with no history of intolerability, during each dialysis session\n3. Has adequate vascular access\n4. Is clinically stable with no hospitalizations in the past 30 days prior to first screening visit as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Has history of major bleeding (International Society on Thrombosis and Haemostasis \\[ISTH\\]) criteria) within the past 3 months prior to the first screening visit as described in the protocol\n2. Has known bleeding conditions (eg, Hemophilia A, B or C, von Willebrand's disease) hemorrhagic tumor sites, or other conditions with a high risk for bleeding (eg, hepatic disease associated with coagulopathy)\n3. Current use of oral anticoagulants (eg, warfarin, Direct Oral Anti-Coagulant \\[DOACs\\]) or dual antiplatelet therapy for clinical indication\n4. Heart failure as classified by New York Heart Association (NYHA) class III or IV\n5. Has a sustained uncontrolled hypertension as described in the protocol\n\nNote: Other protocol-defined Inclusion\u002F Exclusion criteria apply",{"count":59,"type":21},36,[61],"PHASE1","This study will evaluate three Investigational Medicinal Products (IMPs) called REGN9933, REGN7508, and REGN9533.\n\nThe study is focused on participants with End-Stage Kidney Disease (ESKD) treated with hemodialysis and standard anticoagulant treatment, such as heparin, to reduce the risk of blood clots as they can lead to serious health problems or be life-threatening. Because participants with ESKD who have hemodialysis have a higher risk of bleeding, the IMPs could be a meaningful new therapeutic option.\n\nThe main aim of the study is to see what side effects may happen from taking REGN9933, REGN7508, or REGN9533.\n\nThe study is looking at several other research questions, including:\n\n* How much IMP is in the blood at different times and\n* If the IMPs affect the ability of the blood to clot normally",[64],"End-Stage Kidney Disease (ESKD)",[66,67,68,69,70],"Hemodialysis (HD)","Thrombosis","Bleeding","Blood clots","Chronic Kidney Disease (CKD)","2026-08-06",{"date":73,"type":42},"2026-08-12",{"date":75,"type":21},"2026-09-09",{"date":77,"type":21},"2027-03-25",{"name":79,"class":80},"Regeneron Pharmaceuticals","INDUSTRY",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":89,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":92,"briefSummary":93,"conditions":94,"keywords":95,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":109},"100649896","dialysis-less-frequently-in-the-elderly-100649896","NCT07738731","Dialysis Less Frequently in the Elderly","A Randomized Controlled Study of Dialysis Less Frequently in the Elderly","DLITE","Inclusion Criteria:\n\n1. patients aged 70 or above\n2. have developed end stage kidney disease and require hemodialysis treatment\n\nExclusion Criteria:\n\n1. Hospitalized patients without an alternate level of care designation\n2. Those with missed hemodialysis sessions due to non-adherence during the first 7 weeks of hemodialysis treatment\n3. Patients already prescribed twice weekly hemodialysis\n4. Patients who are medically unsuitable as per primary care team and site investigator\n5. anticipated significant barriers to ascertainment of patient-reported experience measures","70 Years",{"count":91,"type":21},210,[24],"Many people who have kidney failure require hemodialysis treatments to stay alive. Hemodialysis is a procedure that cleans the blood of the toxins and fluids that build up when kidneys don't work. Most patients receive hemodialysis treatment three times every week and each treatment lasts 4 hours. These patients spend 156 days per year receiving hemodialysis treatments. This is a very large time burden which has a tremendous impact on well-being and life satisfaction. Current usual approach of prescribing three hemodialysis treatments per week is not based on good studies and assumes that all people need the same number of hemodialysis treatments per week regardless of their age, values, life expectancy or other health conditions. Over time, increasingly more elderly people are needing to start hemodialysis treatments. The investigators have conducted a preliminary study that shows that patients who are 70 years of age or older can do well when only receiving only two hemodialysis treatments per week. In this preliminary study, receiving two hemodialysis treatments per week was no different than three hemodialysis treatments per week with regards to important safety measures including blood values and management of body fluid levels. The investigators now propose to carry out a much larger study in many centers across Canada that will compare two times per week hemodialysis treatments to three times per week hemodialysis treatments in elderly patients who have reached kidney failure and are beginning their hemodialysis journey. The investigators want to know if receiving hemodialysis treatments twice per week increases the number of days that a patient is able to spend at home without increasing rates of hospitalization or death compared to receiving hemodialysis treatments three times per week. The investigators also want to know if this is better for people's quality of life, safe, less expensive for the health care system and friendlier to the environment. The results of this study will help elderly patients needing to start hemodialysis treatments, medical care teams who help make decisions about how many hemodialysis treatments per week are necessary as well as kidney organizations that oversee kidney care for patients in Canada and around the world.",[28,27],[96,97,98,99],"Hemodialysis treatment frequency","Elderly","Quality of Life","mortality","2026-07-29",{"date":102,"type":42},"2026-07-31",{"date":104,"type":21},"2026-10",{"date":106,"type":21},"2031-10",{"name":108,"class":49},"Queen's University",11,{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":120,"conditions":121,"keywords":122,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":50},"100637925","phase-1-a-phase-1b-study-to-evaluate-the-pk-of-csl300-clazakizumab-in-chinese-subjects-with-end-stage-kidney-disease-eskd-100637925","NCT07619820","A Phase 1b Study to Evaluate the PK of CSL300 (Clazakizumab) in Chinese Subjects With End Stage Kidney Disease (ESKD)","A Phase 1b, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Pharmacokinetics and Safety of CSL300 (Clazakizumab) in Chinese Subjects With End Stage Kidney Disease Undergoing Dialysis","Inclusion Criteria:\n\n* Participants has provided written informed consent and is willing and able to adhere to all protocol requirements.\n* Aged 18 or older, inclusive, at the time of providing written informed consent.\n* Diagnosis of ESKD undergoing maintenance dialysis for at least 12 weeks before Screening.\n\nExclusion Criteria:\n\n* Exclusion related to risk of infection: concomitant use of systemic immunosuppressant agents, primary immunodeficiency, positive test for active tuberculosis (TB), history of latent TB without completion of full course of prophylactic treatment, evidence of human immunodeficiency virus infection during Screening, seropositivity for hepatitis B surface antigen or positive hepatitis B virus (HBV) DNA during Screening, seropositivity for hepatitis C virus ribonucleic acid during Screening, diagnosis of clinically significant active infection, history of \u002F OR current invasive fungal infection OR other opportunistic infection OR recurrent cellulitis (defined as 2 or more episodes in the year prior to screening), administration of a live vaccine within 6 weeks of start of Screening, presence of urinary catheter, or evidence of wet gangrene or nonhealing ulcers.\n* Exclusion related to laboratory abnormalities: abnormal liver function tests, neutropenia, thrombocytopenia, or significant anemia.\n* Exclusion related to medical history: any life-threatening disease expected to result in death within 12 months (other than cardiovascular disease), evidence of active hepatic disease and \u002F or moderate or severe hepatic impairment, recent unplanned hospitalization (\\\u003C 30 days) prior to Screening, recent (\\\u003C 3 months) major surgery or planned major surgery known at the time of Screening, poorly controlled hypertension, a present or previous (\\\u003C 5 years) malignancy except for basal cell carcinoma, fully excised squamous cell carcinoma of the skin, or nonrecurrent (\\\u003C 5 years of Screening) cervical carcinoma in situ, active or recent (\\\u003C 30 days of Screening) clinically severe bleeding, a scheduled kidney transplant within 6 months of Screening, a history of anaphylaxis or hypersensitivity to CSL300 or any constituents of the product, or a history of demyelinating disorders.\n* Exclusion related to risk of gastrointestinal perforation: a history of GI perforation, inflammatory bowel disease (except fully excised ulcerative colitis), or peptic ulcer disease (\\\u003C 12 months before Screening), a history of diverticular disease or diverticulitis (except if disease has been fully excised). An incidental finding of diverticulosis (presence of small diverticula) and no history of symptoms, complications, or any episodes requiring treatment may be eligible for the study based on investigator's judgment. However, any history of complications, inflammation, or infection suggestive of diverticulitis or diverticular disease is exclusionary, inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis except if fully excised, or prior gastric bypass surgery.\n* Exclusion related to treatment compliance: evidence of inadequate dialysis, unwillingness or inability to comply with study procedures, a history of noncompliance with medical treatments, or ongoing alcohol or illicit substance abuse.\n* Current or recent participation in research study involving an experimental agent \\\u003C 3 months of Screening.\n* Pregnant, breastfeeding, or unwillingness to practice adequate contraception during the study and for 5 months after the last dose of investigational product.\n* The presence of any condition that in the opinion of the Investigator would (1) compromise the safety of the participant in case of participation in the study, (2) compromise the quality of the data, and \u002F or (3) limit the life expectancy of the participant to \\\u003C 1 year.\n* The Sponsor determines that the participant is no longer needed for participation in study.",{"count":118,"type":21},24,[61],"This is a phase 1b, partial-blind (Sponsor unblinded), randomized, multicenter, placebo-controlled study. The primary objective of this study is to evaluate the pharmacokinetics (PK) of CSL300 after single and multiple doses in Chinese participants with end stage kidney disease (ESKD) undergoing dialysis.",[27],[123,124,125,126,127,128,129],"High-sensitivity C-reactive protein","High-density lipoprotein cholesterol","Interleukin-6","Humanized Monoclonal antibody","Atherosclerotic cardiovascular disease","Diabetes mellitus","Systemic inflammation","RECRUITING","2026-07-03",{"date":133,"type":42},"2026-07-07",{"date":135,"type":42},"2026-06-17",{"date":137,"type":21},"2027-11-30",{"name":139,"class":80},"CSL Behring",{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":148,"enrollmentInfo":149,"targetDuration":4,"studyType":22,"phases":151,"briefSummary":152,"conditions":153,"keywords":155,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":50},"100646983","medium-cut-off-and-high-flux-membranes-on-mineral-and-bone-metabolism-in-hemodialysis-patients-100646983","NCT07685223","Medium Cut-Off and High-Flux Membranes on Mineral and Bone Metabolism in Hemodialysis Patients","Prospective Comparative Evaluation of the Effects of Medium Cut-Off and High-Flux Hemodialysis Membranes on Mineral and Bone Metabolism Biomarkers and Body Composition in Maintenance Hemodialysis Patients","MBD-HD","Inclusion Criteria:\n\n* Age 18 to 80 years.\n* Receiving maintenance hemodialysis for at least 6 months.\n* Clinically stable and receiving thrice-weekly hemodialysis.\n* Able to comply with study procedures, questionnaires, and scheduled assessments.\n* Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n* Acute infection at screening or enrollment.\n* Major surgery within the previous 3 months.\n* Active malignancy requiring ongoing treatment.\n* Terminal illness with limited life expectancy.\n* Physical or cognitive impairment preventing completion of study procedures or questionnaires.\n* Inability or unwillingness to provide written informed consent.","80 Years",{"count":150,"type":21},30,[24],"This study aims to compare the effects of medium cut-off (MCO) and high-flux hemodialysis membranes on mineral and bone metabolism biomarkers in patients receiving maintenance hemodialysis. Chronic kidney disease-mineral and bone disorder (CKD-MBD) is characterized by disturbances in biomarkers such as fibroblast growth factor-23 (FGF-23) and sclerostin, which are associated with bone turnover, vascular calcification, and adverse clinical outcomes.\n\nThis is a single-center, prospective, randomized, open-label, two-sequence, two-period crossover clinical study. Thirty adult patients receiving maintenance hemodialysis will be randomized to receive either MCO membrane treatment followed by high-flux membrane treatment or the reverse sequence, with each treatment period lasting three months.\n\nSerum FGF-23 and sclerostin levels will be measured at baseline, Month 3, and Month 6. Additional assessments will include pulse wave velocity (PWV), body composition monitoring (BCM), handgrip strength, health-related quality of life (KDQOL-36), pruritus severity (UP-Dial), and pain assessment (SF-MPQ). The study will evaluate whether MCO membranes provide additional benefits compared with conventional high-flux membranes regarding CKD-MBD-related biomarkers and patient-centered outcomes.",[27,28,154],"Chronic Kidney Disease Mineral and Bone Disorder",[156,157,158,159,160,161,162,163,164],"End-Stage Kidney Disease","High-Flux Hemodialysis","Medium Cut-Off Membrane","Pulse Wave Velocity","Body Composition Monitor","Handgrip Strength","FGF-23","Sclerostin","CKD-MBD","2026-06-30",{"date":167,"type":42},"2026-07-06",{"date":169,"type":21},"2026-07",{"date":171,"type":21},"2027-01",{"name":173,"class":49},"Gazi University",{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":181,"sex":17,"minAge":18,"maxAge":148,"enrollmentInfo":182,"targetDuration":184,"studyType":185,"phases":4,"briefSummary":186,"conditions":187,"keywords":189,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":198,"startDateStruct":199,"completionDateStruct":200,"leadSponsor":202,"locationsCount":50},"100646683","cardiovascular-and-bone-mineral-markers-in-dialysis-patients-and-healthy-controls-100646683","NCT07686978","Cardiovascular and Bone Mineral Markers in Dialysis Patients and Healthy Controls","Prospective Comparative Evaluation of the Biochemical and Clinical Effects of Different Dialysis Modalities on Cardiovascular Status and Bone Mineral Metabolism","Inclusion Criteria:\n\n* Age 18 to 80 years.\n* For dialysis cohorts: diagnosis of end-stage kidney disease and receiving maintenance hemodialysis or peritoneal dialysis.\n* For dialysis cohorts: receiving regular hemodialysis, continuous ambulatory peritoneal dialysis, or automated peritoneal dialysis for at least 6 months.\n* For healthy controls: no known kidney disease, with estimated glomerular filtration rate greater than 90 mL\u002Fmin\u002F1.73 m².\n* For healthy controls: no known systemic inflammatory disease or active malignancy.\n* Able to comply with planned study procedures, including pulse wave velocity measurement, Body Composition Monitor assessment, questionnaires, and biomarker measurements.\n* Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n* Inability to comply with study measurements or questionnaire assessments.\n* Refusal or inability to provide written informed consent.\n* Age younger than 18 years or older than 80 years.\n* Acute infection.\n* Recent major surgical intervention.\n* Active malignancy.\n* Terminal illness with limited life expectancy.\n* Mental, cognitive, physical, or clinical condition preventing participation in study procedures.",true,{"count":183,"type":21},100,"1 Year","OBSERVATIONAL","This observational study will compare cardiovascular status, bone mineral metabolism, systemic inflammation, body composition, functional status, quality of life, pruritus, and pain among patients receiving different renal replacement therapy modalities and healthy controls.\n\nAdult participants will be included in four groups: maintenance hemodialysis, continuous ambulatory peritoneal dialysis, automated peritoneal dialysis, and healthy controls. No new treatment, drug, dialysis modality, or experimental device will be assigned as part of the study. Participants will continue their routine clinical care.\n\nSerum interleukin-6 (IL-6), vascular cell adhesion molecule-1 (VCAM-1), fibroblast growth factor-23 (FGF-23), and sclerostin levels will be measured. Arterial stiffness will be assessed using pulse wave velocity (PWV), and body composition will be assessed using the Body Composition Monitor (BCM). Handgrip strength, quality of life, pruritus, and pain scores will also be evaluated.\n\nThe study will also explore correlations between biochemical biomarkers, arterial stiffness, body composition, and patient-reported outcomes. In the automated peritoneal dialysis group, objective treatment adherence will additionally be assessed using the Sharesource (Baxter\u002FVantive) cloud-based remote patient monitoring platform.",[64,28,188],"Peritoneal Dialysis (PD)",[28,190,191,192,193,163,125,194,159,160,195,196,197],"Continuous Ambulatory Peritoneal Dialysis","Automated Peritoneal Dialysis","Sharesource","Fibroblast Growth Factor-23","Vascular Cell Adhesion Molecule-1","Kidney Disease Quality of Life-36","Uremic Pruritus in Dialysis Patients","Short-Form McGill Pain Questionnaire",{"date":133,"type":42},{"date":169,"type":21},{"date":201,"type":21},"2027-07",{"name":173,"class":49},{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":209,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":148,"enrollmentInfo":210,"targetDuration":4,"studyType":22,"phases":211,"briefSummary":212,"conditions":213,"keywords":216,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":222,"leadSponsor":223,"locationsCount":50},"100645108","randomized-cross-over-comparison-of-medium-cut-off-and-high-flux-hemodialysis-membranes-100645108","NCT07679763","Randomized Cross-Over Comparison of Medium Cut-Off and High-Flux Hemodialysis Membranes","Randomized Cross-Over Evaluation of Medium Cut-Off and High-Flux Hemodialysis Membranes on Inflammation and Cardiovascular Function in Maintenance Hemodialysis Patients","MCO-HD",{"count":150,"type":21},[24],"Patients receiving maintenance hemodialysis are at increased risk of cardiovascular disease, chronic inflammation, endothelial dysfunction, and impaired quality of life. Medium cut-Off (MCO) hemodialysis membranes have been developed to enhance the removal of middle-molecular-weight uremic toxins compared with conventional high-flux membranes, which may improve inflammatory status and cardiovascular health.\n\nThe aim of this study is to compare the effects of MCO and high-flux hemodialysis membranes on inflammatory biomarkers and cardiovascular function in adult patients receiving maintenance hemodialysis. The primary outcomes are changes in serum interleukin-6 (IL-6) and vascular cell adhesion molecule-1 (VCAM-1) levels. Secondary outcomes include arterial stiffness assessed by pulse wave velocity (PWV), body composition assessed by Body Composition Monitor (BCM), handgrip strength, and patient-reported outcomes including quality of life, pruritus, and pain scores.\n\nThis is a prospective, randomized, open-label, two-sequence, two-period crossover study conducted at Gazi University Faculty of Medicine. Thirty adult hemodialysis patients will be randomized to one of two treatment sequences. Participants in Sequence A will receive MCO dialysis membranes for the first 3 months followed by high-flux membranes for the next 3 months. Participants in Sequence B will receive high-flux membranes for the first 3 months followed by MCO membranes for the next 3 months. Blood samples and clinical assessments will be performed at baseline, month 3, and month 6.\n\nThe study is expected to provide evidence regarding the effects of different dialysis membrane technologies on inflammation and cardiovascular health and may contribute to optimizing membrane selection in routine hemodialysis practice.",[27,28,214,215],"Cardiovascular Diseases (CVD)","Inflammation",[156,157,158,125,217,215,218,159,160],"VCAM-1","Cardiovascular Function",{"date":220,"type":42},"2026-07-01",{"date":169,"type":21},{"date":171,"type":21},{"name":173,"class":49},{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":230,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":22,"phases":234,"briefSummary":235,"conditions":236,"keywords":241,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":4},"100643135","the-adaptive-platform-trial-for-kidney-disease-100643135","NCT07595952","The Adaptive Platform Trial for Kidney Disease","APT-KIDNEY: The Adaptive Platform Trial for Kidney Disease","APT-KIDNEY","Eligibility Criteria - Inclusion\n\n1. Adults with age ≥18 years\n2. eGFR \\\u003C30 ml\u002Fmin\u002F1.73m² for ≥3 months or end-stage kidney disease on dialysis or Kidney transplant with functioning graft (any eGFR)\n3. Ability to provide informed consent\n4. Meets eligibility criteria for at least one currently active APT-KIDNEY domain\n\nEligibility Criteria - Exclusion\n\n1. Refusal to provide informed consent\n2. Participation in another interventional trial whose protocol prohibits co-enrollment in APT-KIDNEY\n3. Any condition that, in the investigator's judgment, makes participation in any APT-KIDNEY domain unsafe or impractical",{"count":233,"type":21},5000,[24],"Background: Randomized clinical trials (RCTs) are essential for evaluating intervention effects but are often challenged by regulatory and logistical burdens, high costs, and extended timelines. To address these challenges, the 'Adaptive Platform Trial in Kidney Disease' (APT-KIDNEY) will establish an investigator-initiated platform trial built on a unified regulatory, contractual, and operational framework. The platform emphasizes adaptive, cost-efficient methodology, automated data capture via linkage to electronic health records and administrative registers, and stakeholder engagement.\n\nObjectives: The primary objective of APT-KIDNEY is to establish an adaptive platform trial for evaluation of multiple interventions in patients with advanced kidney disease as defined by an estimated glomerular filtration rate \\\u003C 30 ml\u002Fmin\u002F1.73 m2 or end-stage kidney disease (ESKD) on dialysis or conservative care.\n\nStudy design: APT-KIDNEY is a pragmatic, randomized, embedded, multifactorial, adaptive platform trial with interventions organized into domains, emphasizing low-intervention comparisons. Domains may be open-label or blinded and will be able to use response-adaptive randomization, adaptive stopping and arm-dropping, and adaptive enrichment to enhance efficiency and relevance where applicable.\n\nStudy population: Adults (≥18 years) with advanced kidney disease defined by eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2 for ≥3 months or ESKD on hemo- or peritoneal dialysis who are eligible for ≥1 one domain. Key exclusions include inability to provide informed consent; domain-specific exclusions may apply, but eligibility cannot be broadened beyond the core protocol.\n\nTrial outcomes: Core outcomes will be all-cause mortality, major adverse cardiovascular events (nonfatal myocardial infarction, nonfatal ischemic stroke, or cardiovascular death), and health-related quality of life (EQ-5D-5L).\n\nAbbreviated methods: APT-KIDNEY will permit domains to use frequentist and\u002For Bayesian methods. Primary analyses will target prespecified primary estimands and be conducted using the full analysis set. Prespecified sensitivity analyses will assess robustness to alternative strategies for intercurrent events and missing data, including per-protocol and as-treated supportive analyses. Outcomes are analyzed with generalized linear\u002Fmixed models and time-to-event methods with covariate adjustment. Frequentist analyses will be fixed-sample or group-sequential; results will be reported with 95% CIs and p-values, and Bayesian analyses will report posterior effects with 95% credible intervals and posterior probabilities. Bayesian domains will primarily use neutral, mildly skeptical priors. Multiplicity will be controlled at the domain level by a prespecified hierarchy: primary comparisons will precede secondary outcomes. Advanced adaptive domains will be evaluated by simulation to quantify operating characteristics including, power and Type I error, and the impact of outcome delays and missing data.\n\nPerspectives: APT-KIDNEY will establish an enduring, investigator-led platform for pragmatic, embedded nephrology trials, reducing start-up time and administrative burden through a shared regulatory and operational framework. Using standardized core outcomes and automated follow-up via electronic health records and national registers, it will generate faster, comparable, practice-relevant evidence across multiple interventions.",[237,238,64,239,240],"Kidney Disease","Chronic Kidney Disease (Stages 4 and 5)","Dialysis","Kidney Transplantation",[242,243,244,245],"Chronic kidney disease","Kidney transplantation","End-stage kidney disease","Platform trial","2026-06-08",{"date":248,"type":42},"2026-06-10",{"date":250,"type":21},"2026-10-01",{"date":252,"type":21},"2066-12-31",{"name":254,"class":49},"Nicholas Carlson",{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":261,"eligibilityCriteria":262,"healthyVolunteers":11,"sex":17,"minAge":263,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":22,"phases":266,"briefSummary":267,"conditions":268,"keywords":274,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":50},"100566830","dialysis-with-expanded-solute-removal-100566830","NCT06660277","DIALysis With EXpanded Solute Removal","DIALysis With EXpanded Solute Removal (DIALEX): A Large, Simple Randomized Trial to Evaluate the Major Health Effects of Expanded Versus Conventional Hemodialysis.","DIALEX","Inclusion Criteria: Inclusion requires that all the following are present:\n\n1. One of:\n\n   1. Age 60 years or older; or\n   2. Age 45 to 59 years with a history of diabetes mellitus (Type 1 or Type 2) regardless of current glycemic status; and\n2. Receiving any form of dialysis regularly for the previous 90 days; and\n3. Currently receiving HD in-centre (main or satellite unit) 3 or more times per week; and\n4. A valid provincial or territorial health insurance card number.\n\nExclusion Criteria: Patients are ineligible if they meet any of the following criteria:\n\n1. Not appropriate for this study in the opinion of the treating nephrologist or dialysis nurse practitioner due to any of:\n\n   1. Known or anticipated intolerance to the Nipro Elisio HX dialyzer; or\n   2. Planned to receive HDF; or\n   3. Planned to receive nocturnal HD; or\n   4. Anticipated to discontinue in-centre HD in the next 3 months for any reason (examples: palliation, transplantation, home dialysis, recovery of kidney function, death, others); or\n   5. Anticipated severe non-adherence to the frequency or duration of prescribed dialysis treatment; or\n   6. An overriding clinical preference for expanded HD (i.e., dialysis with the Elisio HX or other comparable dialyzer, such as Baxter TheranovaTM); or\n   7. Another medical, psychosocial, or logistical reason; or\n2. Enrolled in another clinical trial that explicitly prohibits concurrent participation in other clinical trials or that would substantially interfere with adherence to the DIALEX procedures (note that DIALEX otherwise permits concurrent participation in other trials); or\n3. Previously enrolled in this trial; or\n4. Declined participation.","45 Years",{"count":265,"type":21},4800,[24],"The goal of this clinical trial is to evaluate the health effects of expanded hemodialysis in patients receiving hemodialysis. The main question it aims to answer is:\n\n1\\) Does expanded hemodialysis reduce the risk of death from any cause?\n\nResearchers will compare expanded hemodialysis to conventional hemodialysis (the treatment currently used for the majority of patients receiving hemodialysis) to see if expanded hemodialysis works to improve patient outcomes.\n\nParticipants will continue to receive their regularly scheduled hemodialysis treatments using either a super high-flux\u002Fexpanded dialysis filter or a high-flux\u002Fconventional dialysis filter. All other aspects of treatments remain the same. No additional tests or visits are required. Data will be obtained using administrative healthcare databases and medical record review (at a subset of participating locations).",[269,64,270,271,237,272,273,28],"Chronic Kidney Disease Requiring Hemodialysis","Chronic Kidney Disease Requiring Chronic Dialysis","Pragmatic Randomized Controlled Trial","Renal Insufficiency, Chronic","Kidney Failure, Chronic",[275,276,277,278,279,280,281],"Nipro Elisio HX","RCT","Dialyzer","Hemodialysis Filter","Super-High Flux Dialyzer","High-Flux Dialyzer","Expanded Hemodialysis","2025-08-22",{"date":284,"type":42},"2025-08-28",{"date":286,"type":42},"2025-08-12",{"date":288,"type":21},"2030-08",{"name":290,"class":49},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's",{"id":292,"slug":293,"hasResults":11,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":181,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":22,"phases":300,"briefSummary":301,"conditions":302,"keywords":303,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":4},"100600712","phase-1-pharmacokinetics-of-oral-letermovir-in-adults-with-end-stage-kidney-disease-with-or-without-haemodialysis-100600712","NCT07101055","Pharmacokinetics of Oral Letermovir in Adults With End-Stage Kidney Disease With or Without Haemodialysis","A Prospective, Open-Label, Single-Centre, Comparative Pharmacokinetic Study of Oral Letermovir (PREVYMIS) in Patients (i) Undergoing Intermittent Haemodialysis and (ii) Not Undergoing Intermittent Haemodialysis","Inclusion Criteria:\n\nAll participants of childbearing potential who are engaging in sexual activity that could result in pregnancy must be willing to use highly effective contraception from screening through 30 days post-dose of letermovir. Male participants must also agree not to donate sperm during this period.\n\nGroup 1:\n\n* Adult participants (≥18 years old).\n* Estimated Glomerular filtration rate (eGFR) \\\u003C 15 mL\u002Fmin\u002F1.73 m2.\n* Clinical indication for regular intermittent haemodialysis.\n* Agreement to receive a single 480 mg dose of letermovir.\n* Willing and able to provide informed consent.\n* Consent to cannula placement for blood draws.\n\nGroup 2:\n\n* Adult participants (≥18 years old).\n* Estimated Glomerular filtration rate (eGFR) \\\u003C 15 mL\u002Fmin\u002F1.73 m2.\n* No clinical indication for regular intermittent haemodialysis.\n* Agreement to receive a single 480 mg dose of letermovir.\n* Willing and able to provide informed consent.\n* Consent to cannula placement for blood draws.\n\nExclusion Criteria:\n\n* Participants who lack the capacity to provide informed consent.\n* Patients with suspected or known hypersensitivity to any of the active or inactive ingredients of the oral letermovir formulation.\n* Patients who are taking any of the following medications, unless these can be safely discontinued temporarily for the duration of the study as determined by the study investigator: statins (pitavastatin, simvastatin, atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin) and proton pump inhibitors (omeprazole, pantoprazole).\n* Patients who are taking any of the following medications: cyclosporine, pimozide, ergot alkaloids, or drug metabolism inducers including amiodarone, nafcillin, warfarin, carbamazepine, phenobarbital, phenytoin, glyburide, voriconazole, rifabutin, rifampicin, pimozide, thioridazine, bosentan, St. John's Wort, efavirenz, etravirine, nevirapine, sirolimus, tacrolimus, modafinil, CYP2C8 substrates (e.g., repaglinide, rosiglitazone), or CYP3A substrates (e.g., alfentanil, fentanyl, midazolam, quinidine).\n* Patients with severe hepatic impairment.\n* Pregnant, planning to conceive, breastfeeding, or intending to breastfeed during the study period.\n* Presence of any rapidly progressing disease or immediately life-threatening illness (i.e., death deemed imminent within 48 hours).\n* Any condition or circumstance that, in the investigator's opinion, would compromise patient safety or the integrity of study data.",{"count":299,"type":21},20,[61],"This study aims to understand how the antiviral medication letermovir (PREVYMIS) is processed by the body in adults with end-stage kidney disease (ESKD), including those who are receiving intermittent haemodialysis and those who are not. Letermovir is already approved in many countries, including Australia, for preventing cytomegalovirus (CMV) infections in patients who have received stem cell transplants. However, its pharmacokinetics - or how the drug is absorbed, distributed, and cleared from the body - have not been studied in patients with ESKD, especially those on dialysis.\n\nThis is a single-centre, open-label, interventional pharmacokinetic study. It will recruit 20 adult participants, split into two groups: 10 participants on intermittent haemodialysis and 10 not undergoing dialysis. All participants will receive a single oral dose of 480 mg letermovir. The study does not involve treatment for CMV infection. Instead, it focuses only on how the drug behaves in the body in this patient population.\n\nParticipants will have blood samples collected before and after taking the medication to measure drug concentrations over time. In patients on dialysis, an additional sample will be taken from the dialysis machine to understand if letermovir is removed during treatment. No more than 35 mL of blood (around two tablespoons) will be collected across two study visits.\n\nThe goal of this study is to generate important safety and dosing information to help guide future use of letermovir in people with kidney failure. It is expected that these findings will support more informed clinical decisions and potentially lead to updated dosing recommendations for this group.\n\nThe study is funded by Merck Sharp \\& Dohme LLC (MSD), the manufacturer of letermovir, and is being conducted by researchers from The University of Queensland Centre for Clinical Research (UQCCR) and the Royal Brisbane and Women's Hospital (RBWH). To support participation, prepaid meal vouchers, taxi vouchers, or parking tickets will be provided so that participants do not incur any out-of-pocket expenses.\n\nParticipation is voluntary. The study has been approved by a Human Research Ethics Committee and is conducted according to national ethical guidelines.",[64],[304,305,306,307,308],"pharmacokinetics","letermovir","intermittent haemodialysis","renal impairment","chronic kidney failure","2025-07-30",{"date":311,"type":42},"2025-08-03",{"date":313,"type":21},"2025-09",{"date":315,"type":21},"2027-12",{"name":317,"class":49},"Jason A Roberts"]