[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Nicholas Carlson\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":77},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"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":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100643135","the-adaptive-platform-trial-for-kidney-disease-100643135",false,"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","ALL","18 Years",{"count":20,"type":21},5000,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.",[27,28,29,30,31],"Kidney Disease","Chronic Kidney Disease (Stages 4 and 5)","End-Stage Kidney Disease (ESKD)","Dialysis","Kidney Transplantation",[33,34,35,36],"Chronic kidney disease","Kidney transplantation","End-stage kidney disease","Platform trial","NOT_YET_RECRUITING","2026-06-08",{"date":40,"type":41},"2026-06-10","ACTUAL",{"date":43,"type":21},"2026-10-01",{"date":45,"type":21},"2066-12-31",{"name":47,"class":48},"Nicholas Carlson","OTHER",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"100351976","phase-4-the-danish-warfarin-dialysis-study---safety-and-efficacy-of-warfarin-in-patients-with-atrial-fibrillation-on-dialysis-100351976","NCT03862859","The Danish Warfarin-Dialysis Study - Safety and Efficacy of Warfarin in Patients With Atrial Fibrillation on Dialysis","The Danish Warfarin-Dialysis Study: Safety and Efficacy of Warfarin in Patients With Atrial Fibrillation on Dialysis - A Nationwide Parallel-group Open Randomized Clinical Trial","DANWARD","Inclusion Criteria:\n\n* Patients ≥18 years on chronic dialysis due to end-stage renal disease\n* Non-valvular paroxysmal, persistent, or permanent atrial fibrillation OR non-treated (for \\>2 months) prevalent paroxysmal, persistent or permanent atrial fibrillation as documented by an electrocardiogram or an episode of ≥30 seconds on Holter monitor, or episodes ≥ 6 minutes on event recorders or any other recording device.\n* Competence to understand the study rationale, including potential risks and benefits associated with treatment, necessary for written informed consent.\n\nExclusion Criteria:\n\n* CHA2DS2-VASc Score ≤1\n* Other indications for oral anticoagulation treatment (pulmonary embolism \\\u003C 6 months, deep vein thrombosis \\\u003C3 months, mechanical heart valve prosthesis) irrespective of whether treatment is implemented\n* Ongoing dual antiplatelet treatment\n* Malignancy (with exception of non-melanoma skin cancer) with recent \\\u003C 1 year, ongoing, or planned curative, or palliative chemo- , radiation-, and\u002For scheduled surgical therapy\n* Endoscopy with gastrointestinal ulcer \\\u003C1 month\n* Esophageal varices\n* Autoimmune og genetic coagulation disorders\n* Congenital alactasia, Lapp Lactase deficiency or glucose-galactose malabsorption\n* Pending spinal tap\n* Cerebrovascular malformations\n* Arterial aneurysms\n* Ulcers or wounds (Wagner grad \\>1)\n* Bacterial endocarditis \\\u003C 3 months\n* Active bleeding contraindicating anticoagulation\n* Any non-elective and\u002For non-ambulant surgery \\\u003C7 days\n* Cerebral hemorrhage \\\u003C4 weeks\n* Thrombocytopenia (platelet count \\\u003C100 × 109\u002FL) \\\u003C30 days.\n* Severe liver insufficiency (spontaneous international normalized ratio \\>1.5) \\\u003C30 days.\n* Known intolerance to warfarin\n* Use of hypericum perforatum \u002F St. John's Wort\n* Uncontrolled hypertension (repeat blood pressure \\>180\u002F110 mmhg) \\\u003C 30 days\n* Uncontrolled hyperthyroidism (thyroid-stimulating hormone \\\u003C0.1μIU\u002FmL) \\\u003C30 days\n* Pregnancy or lactation\n* Participation in other ongoing intervention trials adjudged to influence study outcomes",{"count":58,"type":21},718,[60],"PHASE4","The study aims to evaluate the appropriateness of initiating oral anticoagulation for stroke risk reduction in dialysis populations with atrial fibrillation. Specifically, the study will assess the overall safety, tolerability, and efficacy of initiating treatment with Warfarin in patients with end-stage renal disease on dialysis and atrial fibrillation.",[63,64,65,66],"Atrial Fibrillation and Flutter","Stroke","Major Bleed","End-stage Renal Disease","RECRUITING","2026-05-17",{"date":70,"type":41},"2026-05-19",{"date":72,"type":41},"2019-10-09",{"date":74,"type":21},"2027-01",{"name":47,"class":48},13,""]