[{"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":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,54,86,115,152],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100645108","randomized-cross-over-comparison-of-medium-cut-off-and-high-flux-hemodialysis-membranes-100645108",false,"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","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.","ALL","18 Years","80 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.",[28,29,30,31],"End Stage Kidney Disease (ESKD)","Hemodialysis","Cardiovascular Diseases (CVD)","Inflammation",[33,34,35,36,37,31,38,39,40],"End-Stage Kidney Disease","High-Flux Hemodialysis","Medium Cut-Off Membrane","Interleukin-6","VCAM-1","Cardiovascular Function","Pulse Wave Velocity","Body Composition Monitor","NOT_YET_RECRUITING","2026-06-30",{"date":44,"type":45},"2026-07-01","ACTUAL",{"date":47,"type":22},"2026-07",{"date":49,"type":22},"2027-01",{"name":51,"class":52},"Gazi University","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":23,"phases":64,"briefSummary":65,"conditions":66,"keywords":72,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"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":63,"type":22},5000,[25],"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.",[67,68,69,70,71],"Kidney Disease","Chronic Kidney Disease (Stages 4 and 5)","End-Stage Kidney Disease (ESKD)","Dialysis","Kidney Transplantation",[73,74,75,76],"Chronic kidney disease","Kidney transplantation","End-stage kidney disease","Platform trial","2026-06-08",{"date":79,"type":45},"2026-06-10",{"date":81,"type":22},"2026-10-01",{"date":83,"type":22},"2066-12-31",{"name":85,"class":52},"Nicholas Carlson",{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":95,"briefSummary":97,"conditions":98,"keywords":99,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":110,"leadSponsor":112,"locationsCount":4},"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":94,"type":22},24,[96],"PHASE1","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.",[28],[100,101,36,102,103,104,105],"High-sensitivity C-reactive protein","High-density lipoprotein cholesterol","Humanized Monoclonal antibody","Atherosclerotic cardiovascular disease","Diabetes mellitus","Systemic inflammation","2026-05-26",{"date":108,"type":45},"2026-06-02",{"date":42,"type":22},{"date":111,"type":22},"2027-11-30",{"name":113,"class":114},"CSL Behring","INDUSTRY",{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":123,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":23,"phases":126,"briefSummary":127,"conditions":128,"keywords":134,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":53},"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":125,"type":22},4800,[25],"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).",[129,69,130,131,67,132,133,29],"Chronic Kidney Disease Requiring Hemodialysis","Chronic Kidney Disease Requiring Chronic Dialysis","Pragmatic Randomized Controlled Trial","Renal Insufficiency, Chronic","Kidney Failure, Chronic",[135,136,137,138,139,140,141],"Nipro Elisio HX","RCT","Dialyzer","Hemodialysis Filter","Super-High Flux Dialyzer","High-Flux Dialyzer","Expanded Hemodialysis","RECRUITING","2025-08-22",{"date":145,"type":45},"2025-08-28",{"date":147,"type":45},"2025-08-12",{"date":149,"type":22},"2030-08",{"name":151,"class":52},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's",{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":159,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":23,"phases":162,"briefSummary":163,"conditions":164,"keywords":165,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"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.",true,{"count":161,"type":22},20,[96],"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.",[69],[166,167,168,169,170],"pharmacokinetics","letermovir","intermittent haemodialysis","renal impairment","chronic kidney failure","2025-07-30",{"date":173,"type":45},"2025-08-03",{"date":175,"type":22},"2025-09",{"date":177,"type":22},"2027-12",{"name":179,"class":52},"Jason A Roberts"]