[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"dialysis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:dialysis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,49,78,111,135,170,193,226,258,286,311,338,368,393,423,443,469,493,513,536],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100594271","phase-4-glucagon-like-peptide-1-receptor-agonists-in-patients-receiving-maintenance-dialysis-100594271",false,"NCT07017270","Glucagon-like-peptide-1 Receptor Agonists in Patients Receiving Maintenance Dialysis","GUARD-1","Inclusion Criteria:\n\n1. Age ≥ 18\n2. Receiving chronic maintenance hemodialysis or peritoneal dialysis for ≥ 90 days\n3. confirmed DM2 based on medical history and current or prior receipt of an oral hypoglycemic agent and\u002For insulin.\n4. Ability to provided informed consent or through their substitute decision maker\n\nExclusion Criteria:\n\n1. Type 1 DM\n2. Use of a GLP-1-RA within 30 days prior to screening\n3. Personal or first-degree relative(s) with a history of type 2 multiple endocrine neoplasia syndrome or medullary thyroid cancer, or acute pancreatitis (within 180 days of study screening)\n4. Confirmed pregnancy, women of childbearing potential\n5. Known hypersensitivity to GLP-1-RA\n6. Expected to recover kidney function, stop hemodialysis, pursue palliative care, or transplantation within 6 months\n7. Enrolment in another clinical trial judged by the investigator to interact with the effect of GLP1-RA","ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","This study aims to determine if GLP1RA is safe and tolerable in maintenance dialysis population, adherence, and feasibility of a larger definitive cardiovascular outcome trial in this population. Participants will be randomized 1:1 to either weekly subcutaneous semaglutide versus usual care and followed for 26 weeks.",[26,27,28,29],"Kidney Disease, Chronic","Diabetes","Dialysis","End Stage Kidney Disease (ESRD)",[28,31,32,33,34,35],"Type 2 diabetes","semaglutide","end stage kidney disease","GLP1","GLP1RA","RECRUITING","2026-06-22",{"date":39,"type":40},"2026-06-26","ACTUAL",{"date":42,"type":40},"2025-11-27",{"date":44,"type":20},"2027-09",{"name":46,"class":47},"Unity Health Toronto","OTHER",2,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100419979","access-to-kidney-transplant-of-obese-patients-beginning-dialysis-100419979","NCT04748770","Access to Kidney Transplant of Obese Patients Beginning Dialysis","Transplantob","Inclusion Criteria:\n\n* Age over 18 years old.\n* Patients with BMI≥30 kg\u002Fm2 (for study population) and 25≤BMI≤30 kg\u002Fm2(for control population) one month after dialysis initiation.\n* Patients agree with their data collection.\n\nExclusion Criteria:\n\n* Patients with bariatric surgery history.\n* Patients needed dialysis for graft dysfunction.\n* Data loss.",{"count":19,"type":20},"OBSERVATIONAL","Obesity is in constant increase all over the world and affects 35% of the global population according to the World Health Organisation. It is associated with other cardiovascular risk factors (particularly hypertension and diabetes) and with high morbi-mortality. It is also responsible for an increase of the risk of developing chronic kidney diseases (CKD). In fact, obese patients represent 25% of the dialysis population and Picardy is one of the most affected areas. However, their access to kidney transplant is still restricted and the reasons are not completely understood.",[60,61,28,62],"Kidney Transplant Access","Obese Patients","Comorbidities",[64,65,66,67],"Kidney transplant access","obese patients","dialysis","comorbidities","2026-06-12",{"date":70,"type":40},"2026-06-15",{"date":72,"type":40},"2021-01-11",{"date":74,"type":20},"2026-06",{"name":76,"class":47},"Centre Hospitalier Universitaire, Amiens",1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":90,"conditions":91,"keywords":96,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"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":87,"type":20},5000,[89],"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.",[92,93,94,28,95],"Kidney Disease","Chronic Kidney Disease (Stages 4 and 5)","End-Stage Kidney Disease (ESKD)","Kidney Transplantation",[97,98,99,100],"Chronic kidney disease","Kidney transplantation","End-stage kidney disease","Platform trial","NOT_YET_RECRUITING","2026-06-08",{"date":104,"type":40},"2026-06-10",{"date":106,"type":20},"2026-10-01",{"date":108,"type":20},"2066-12-31",{"name":110,"class":47},"Nicholas Carlson",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":21,"phases":120,"briefSummary":121,"conditions":122,"keywords":123,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":77},"100633492","phase-4-canagliflozin-in-dialysis-patients-100633492","NCT07527390","CANagliflozin In DIALysis Patients","CANIDIAP","Inclusion criteria:\n\n* Hemodialysis for more than 3 months (5 also with residual diuresis)\n* Age ≥18 years of age\n* Willing to sign informed consent\n\nExclusion criteria:\n\n* Mentally incapacitated subjects (i.e. not able to sign informed consent)\n* Subjects who participated in a trial with exposure to radiation before, are only allowed to participate if the total cumulative radiation burden in their life does not exceed 1 mSv per year, counting from the age of 18 years.\n* Pregnant women and women of child-bearing potential who are not using reliable contraception\n* Subjects on diuretics are allowed to participate but the dose should be stable for at least 4 weeks prior to screening\n* Subjects already on a SGLT2 inhibitor are allowed to participate, but the drug should be inter-rupted 1 week prior to the first study day till the end of the second study day (as the half-life is 10-13 hours a wash-out of the study drug of at least 7-days should be considered)\n* History of hypersensitivity to canagliflozin or another SGLT2 inhibitor\n* Severe claustrophobia\n* History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening.\n* Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following:\n\n  * Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection\n  * Gastro-intestinal ulcers and\u002For gastrointestinal or rectal bleeding within last six months\n  * Pancreatic injury or pancreatitis within the last six months\n  * Evidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3x ULN at inclusion visit, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt\n  * Use of rifampicin and cholestryramine\n* Established peripheral arterial disease\n* Active cardiovascular disease: myocardial infarction, angina pectoris, percutaneous translu-minal coronary angioplasty, coronary artery bypass grafting, stroke, or heart failure (NYHA I-IV) admission \\\u003C 3 months before inclusion\n* People using digoxin and\u002For lithium\n* Patients with an active malignancy",{"count":119,"type":20},10,[23],"Rationale:\n\nSodium glucose co-transporter 2 (SGLT2) inhibitors are a relatively new class of drugs originally developed for the treatment of diabetes. Cardiovascular outcome trials with these drugs showed also beneficial effects of these agents on heart failure, cardiovascular disease and kidney outcomes. Secondary analyses from these trials demonstrated that these benefits were consistent in patients with or without type 2 diabetes and with or without chronic kidney disease (CKD) with a lower eGFR threshold of 20 mL\u002Fmin\u002F1.73m2. However, it is not yet clear if these drugs can also be used in patients with severe kidney disease who require dialysis. This is in part explained because SGLT2 inhibitors bind to a transporter which is located in the luminal side of proximal tubes in the kidney. If kidney function is low, and these patients have no or limited filtering capacity, it is possible that the efficacy of these drugs decrease. Notwithstanding, several animal experiments and preliminary clinical data have suggested that these drugs do have kidney and cardiac protective effects in case of severely decreased kidney function.\n\nThe investigators hypothesize that SGLT2 inhibitors are distributed to several tissues in the body on top of the kidney and therefore the investigators would like to investigate the specific tissue distribution of SGLT2 inhibitors in patients on dialysis with-and without residual diuresis.",[28,93],[124,125],"SGLT2 inhibitors","PET imaging","2026-04-29",{"date":128,"type":40},"2026-05-06",{"date":130,"type":20},"2026-06-01",{"date":132,"type":20},"2027-01-30",{"name":134,"class":47},"University Medical Center Groningen",{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":21,"phases":145,"briefSummary":146,"conditions":147,"keywords":150,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":77},"100634332","laser-acupuncture-for-fatigue-in-hemodialysis-patients-100634332","NCT07538310","Laser Acupuncture for Fatigue in Hemodialysis Patients","Laser Acupuncture Improves Fatigue and Quality of Life in Hemodialysis Patients: a Randomized Double-blind Clinical Trial Pilot Study","LA-HD-Fatigue","Inclusion Criteria:\n\n* Patients with End-Stage Renal Disease (ESRD) who require regular maintenance hemodialysis.\n* Must undergo hemodialysis treatment at least 3 times per week.\n* Aged 18 years or older.\n* Willing and able to provide informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Presence of acute infectious symptoms.\n* Unstable vital signs.\n* Diagnosis of malignant tumors.\n* Pregnancy.\n* Presence of open wounds at the sites designated for laser intervention.\n* Patients with implanted cardiac pacemakers or other cardiac devices.",{"count":144,"type":20},50,[89],"The goal of this clinical trial is to learn if laser acupuncture (low-level laser therapy) works to treat fatigue and improve quality of life in adults with end-stage renal disease (ESRD) undergoing hemodialysis. It will also learn about how laser acupuncture affects blood circulation and autonomic nervous system balance.\n\nThe main questions it aims to answer are:\n\n1. Does laser acupuncture reduce the severity of fatigue and its interference with daily life?\n2. Can laser acupuncture improve related symptoms such as insomnia, poor appetite, and skin itching?\n3. How does laser acupuncture affect objective markers like microcirculation and heart rate variability? Researchers will compare laser acupuncture to a sham treatment (a look-alike procedure using a device that does not emit a laser) to see if laser acupuncture works to treat fatigue.\n\nParticipants will:\n\n1. Receive laser acupuncture or a sham treatment during their regular hemodialysis sessions 3 times a week for 4 weeks.\n2. Have their fatigue and life quality assessed through questionnaires on the first day, at 4 weeks, and at 8 weeks.\n3. Undergo non-invasive tests to measure microcirculation, heart rate variability, and pulse waves, and have photos of their tongue taken for Chinese medicine assessment.",[148,28,149],"ESRD (End Stage Renal Disease)","Fatigue",[151,152,153,154,149,155,156,157,158,159],"Hemodialysis","End-Stage Renal Disease","Laser Acupuncture","Photobiomodulation","Quality of Life","Microcirculation","Low-Level Laser Therapy","Traditional Chinese Medicine","Heart Rate Variability","2026-04-12",{"date":162,"type":40},"2026-04-20",{"date":164,"type":20},"2026-04-08",{"date":166,"type":20},"2027-08-31",{"name":168,"class":169},"Taipei City Hospital","OTHER_GOV",{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":176,"sex":16,"minAge":17,"maxAge":177,"enrollmentInfo":178,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":77},"100241458","mri-technical-development-and-applications-in-kidney-disease-100241458","NCT02421497","MRI Technical Development and Applications in Kidney Disease","For Specific Aim 1: MRI Technical Development Studies\n\nInclusion Criteria:\n\n1\\. Healthy Volunteer\n\nExclusion Criteria:\n\n1. Ferromagnetic implants\n2. Any foreign metal objects in the body\n3. History of shrapnel or shot gun injury\n4. Cardiac pacemakers\n5. Defibrillator\n6. Neuronal stimulator\n7. Magnetic aneurysm clip\n8. Large tattoos on the abdomen or the brain and neck\n9. Hip replacement\n10. Too large to fit in the magnet (body mass index \\>= 40, approx.)\n11. Severe claustrophobia\n12. Women with pregnancy\n\nFor Specific Aim 2: Pilot Studies with Patients\n\nStudies for CKD\n\nInclusion\n\n1. English- speaking as primary language.\n2. Age 45 years and older\n3. Able to complete an approximately 90 minute cognitive testing battery.\n4. Able to sign the informed consent, or allow a caregiver, relative, surrogate, or witness to sign the informed consent if participant is unable to do so.\n5. GFR \\\u003C 90 ml\u002Fmin\u002F1.73m2\n\nExclusion\n\n1. Acute psychiatric illness that would impede cognitive testing\n2. Active chemical dependence, such as alcohol, narcotics or other drugs\n3. Legally blind or unable to complete cognitive tests due to visual loss or deafness\n4. Dialysis dependent or renal transplant recipient at time of screening or baseline\n5. Chronic obstructive pulmonary disease\n6. Severe CI unable to complete the Modified Mini-Mental State Examination \\[3MSE\\]\n\nStudies for Renal Transplantation\n\nInclusion\n\n1. Able to sign the informed consent, or allow a caregiver, relative, surrogate, or witness to sign the informed consent if participant is unable to do so.\n2. Age 45 years and older\n\nExclusion\n\n1. Not on dialysis due to allograft failure\n2. Chronic obstructive pulmonary disease",true,"70 Years",{"count":179,"type":20},180,"Magnetic resonance imaging (MRI), as a non-invasive and non-contrast enhanced technique, has the potential to improve patient health care and management. The overall objective of proposed project is to:\n\n1. develop, customize, and optimize anatomic and functional MRI methods,\n2. explore the use of MRI methods to study CKD and evaluate post-transplant kidneys, and\n3. investigate the potential of MRI in the diagnosis, prognosis, and monitoring of the progression of renal dysfunction.\n\nIn addition to direct studies of the kidney, brain MRI studies will also be performed to identify the cerebrovascular and cognitive effects of chronic renal function deficiency and medical treatment (e.g. hemodialysis and immunosuppression). The brain and kidneys have similar vascular bed, and both are susceptible to vascular injury, which provides the pathological basis for the widely recognized association of reduced renal function with prevalent cerebrovascular diseases (CVDs) and cognitive impairment (CI). The MRI methods in the brain will be applied to explore the origins for widely observed CVDs and prevalent cognitive impairment (CI) in kidney disease patients.",[182,95,28,183],"Chronic Kidney Diseases","Cognition Disorders","2026-04-09",{"date":186,"type":40},"2026-04-13",{"date":188,"type":20},"2028-06-30",{"date":190,"type":20},"2029-12-30",{"name":192,"class":47},"University of Minnesota",{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":202,"conditions":203,"keywords":209,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":225},"100613110","epidemiology-and-processes-of-care-for-renal-replacement-therapy-in-acute-kidney-injury-in-latin-america-100613110","NCT07262320","Epidemiology and Processes of Care for Renal Replacement Therapy in Acute Kidney Injury in Latin America","LATAM-AKID","Inclusion Criteria:\n\n* Adult patient (≥18) admitted to the ICU\n* First ICU admission during current hospitalization\n* Diagnosis of acute kidney injury stage 3 according to KDIGO guidelines\n* RRT initiated no earlier than 3 days before or no later than 7 days after ICU admission\n\nExclusion Criteria:\n\n* Transfer from outside hospital with ongoing RRT\n* RRT exposure of less than 2 days (if CRRT or PD was provided) or less than 2 HD\u002FSLED sessions\n* Kidney failure (ESRD) patients on maintenance dialysis\n* Kidney transplant recipients\n* Previous or new diagnosis of glomerulonephritis",{"count":201,"type":20},1000,"This is an international, multicenter, observational study aimed at investigating acute kidney injury requiring renal replacement therapy (AKI-RRT) in Latin American countries. The main questions this study aims to answer are:\n\n* What is the epidemiology, outcomes, and processes of care for patients with AKI-RRT in Latin America?\n* How do outcomes differ across different countries in Latin America?\n* What factors (demographics, clinical, socioeconomic) influence outcomes in patients with AKI-RRT in Latin America?\n\nThe main aims of this study are to:\n\n* Establish a comprehensive database containing clinical, laboratory, treatment, process, and outcome data of patients with AKI-RRT in Latin America\n* Describe current epidemiology of AKI-RRT in Latin America\n* Compare processes of care and outcomes across different countries in Latin America\n* Provide data resources to facilitate and promote clinical research in AKI-RRT",[28,204,205,206,207,208],"Critically Ill Acute Kidney Injury","Renal Replacement Therapy for Acute Kidney Injury in ICU","Acute Kidney Injury","Renal Replacement Therapy","AKI",[208,210,211,212,213,214,215,66],"ICU","RRT","Latin America","acute kidney injury","renal replacement therapy","intensive care unit","2026-03-11",{"date":218,"type":40},"2026-03-12",{"date":220,"type":40},"2026-03-01",{"date":222,"type":20},"2027-06-30",{"name":224,"class":47},"University of Alabama at Birmingham",15,{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":16,"minAge":234,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":21,"phases":237,"briefSummary":239,"conditions":240,"keywords":244,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":257},"100587829","phase-3-a-study-of-a-novel-iron-based-phosphate-binder-ap301-in-patients-with-hyperphosphatemia-in-the-us-and-china-100587829","NCT06933472","A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China","A Randomized, Double-Blind, Multi-Regional, Phase 3 Study to Evaluate the Efficacy and Safety of AP301 on Serum Phosphorus Control in Chronic Kidney Disease Patients Receiving Maintenance Dialysis With Hyperphosphatemia","RESPOND-2","Key Inclusion Criteria:\n\n* Provision of signed and dated ICF\n* Age ≥ 12 years when signing the ICF\n* Patients on dialysis for ≥ 3 months before signing the ICF and throughout the study\n* For HD patients, spKt\u002FV ≥ 1.2; for PD patients, total Kt\u002FV ≥ 1.7\u002Fweek\n* Patients who receive phosphate-lowering drugs over 4 weeks and their serum phosphate level is:\n\n  1. Screening: 1.13 mmol\u002FL (3.5 mg\u002FdL) ≤ serum phosphate \\\u003C 2.58 mmol\u002FL (8.0 mg\u002FdL)\n  2. After washout: 1.94 mmol\u002FL (6.0 mg\u002FdL) ≤ serum phosphate \\\u003C 3.23 mmol\u002FL (10.0 mg\u002FdL)\n\nKey Exclusion Criteria:\n\n* History or plan of kidney transplantation\n* History or plan of parathyroid intervention 6 months before signing the ICF\n* Serum calcium \\\u003C 1.9 mmol\u002FL (7.6 mg\u002FdL) or \\> 2.75 mmol\u002FL (11 mg\u002FdL) at screening\n* Serum intact parathyroid hormone \\> 127 pmol\u002FL (1200 pg\u002FmL) at screening\n* Presence of clinically significant gastrointestinal (GI) disorder\n* History of gastrectomy or duodenectomy, or GI surgery within 3 months before signing the ICF\n* Known allergic to any ingredient of AP301, or known history of severe allergies leading to emergency medical care\n* Female who are breastfeeding","12 Years",{"count":236,"type":20},264,[238],"PHASE3","The goal of this clinical trial is to learn if AP301 could work in the patients receiving maintenance dialysis with elevated blood phosphate. The main questions it aims to answer are:\n\n* Does AP301 lower blood phosphate levels?\n* Does AP301 works on serum calcium level, calcium times phosphate level, and intact parathyroid hormone level?\n* What discomfort or medical problem do the patients have when taking AP301?\n* Does AP301 improve quality of life in Chinese patients?\n\nThe researchers will compare AP301 to an ineffective comparator (a look-alike substance that contains low dose AP301) to see if AP301 works to treat elevated blood phosphate.\n\nIn the study, the patients will experience the following stages in a chronicle order:\n\n* Stop all using blood phosphate-lowering drugs,\n* Take AP301 or the comparator three times a day for 8 weeks,\n* Take AP301 three times a day for 24 weeks, and\n* Take AP301 or the comparator three times a day for 3 weeks.\n\nIn the first 32 weeks, the dose of AP301 will be adjusted upwards or downwards based on the patient's blood phosphate level and the study doctor's judgment.\n\nIf the participant has a blood phosphate level above or below a certain level, they may receive additional treatment to lower the blood phosphate level.",[241,242,243,28],"Hyperphosphatemia","Chronic Kidney Disease, Receiving Dialysis","ESRD (End-Stage Renal Disease)",[241,245,28,246],"AP301","ESKD","2026-01-28",{"date":249,"type":40},"2026-01-29",{"date":251,"type":40},"2025-06-13",{"date":253,"type":20},"2027-01-10",{"name":255,"class":256},"Alebund Pharmaceuticals","INDUSTRY",42,{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":16,"minAge":266,"maxAge":4,"enrollmentInfo":267,"targetDuration":269,"studyType":57,"phases":4,"briefSummary":270,"conditions":271,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":77},"100556185","cardio-renal-registry-100556185","NCT06521801","Cardio-Renal Registry","Barts Health Cardio-Renal Registry","BHCRR","Informed consent will not be sought for, as patients are automatically included onto a database that we will use for research purposes. No children will be included in this study. Vulnerable adults or those unable to give consent will be included in the study as well if they are referred to the Nephrology team.\n\nInclusion Criteria:\n\n1. Both male and female patients ≥16 years of age will be included\n2. All patients will be reviewed by the Nephrology team a the RLH with renal disease.\n\nExclusion Criteria:\n\n1\\. Patients \\\u003C16 years will not be included in this study.","16 Years",{"count":268,"type":20},60000,"12 Weeks","Cardiovascular disease is the leading cause of morbidity and mortality among patients with chronic kidney disease (CKD). Even after adjustment for known cardiovascular risk factors, including diabetes and hypertension, mortality risk progressively increases with worsening CKD. As glomerular filtration rate (GFR) declines the probability of developing coronary artery disease (CAD) increases linearly, and patients with GFR \\\u003C60 mL\u002Fmin\u002F1.73 m2 have 2-3-fold increased CV mortality risk, relative to patients without CKD. Management of CAD is complicated in CKD patients due to the likelihood of comorbid conditions and potential for side effects. Despite their high cardiovascular risk, ACS patients with renal dysfunction are less commonly treated with guideline-based medical therapy and are less frequently referred for coronary revascularisation. This observation, referred to as the \"treatment risk paradox,\" has been well described and may be explained by physicians' concerns regarding possible nonrenal side effects as well as renal toxicities. Furthermore, patients with severe CKD have traditionally been under-represented in most large cardiovascular clinical trials. Therefore, recommendations for both medical and revascularisation of CAD have relied heavily on extrapolation of results from the non-CKD population.\n\nThis data will add to that literature by assessing the characteristics and outcomes of patients with CAD and CKD. It will also identify and characterise predictors of outcomes, improve risk stratification and diagnostic evaluation.",[272,273,274,275,276,28],"End Stage Renal Disease","Cardio-Renal Syndrome","Myocardial Infarction","Cerebrovascular Accident","Percutaneous Coronary Intervention","2026-01-05",{"date":279,"type":40},"2026-01-07",{"date":281,"type":40},"2024-08-01",{"date":283,"type":20},"2030-06-01",{"name":285,"class":47},"Queen Mary University of London",{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":290,"acronym":291,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":293,"targetDuration":295,"studyType":57,"phases":4,"briefSummary":296,"conditions":297,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":307,"leadSponsor":309,"locationsCount":77},"100612748","left-atrial-appendage-occlusion-in-dialysis-patients-with-atrial-fibrillation-a-multicentre-pilot-study-100612748","NCT07257614","Left Atrial Appendage Occlusion in Dialysis Patients With Atrial Fibrillation: A Multicentre Pilot Study","LAAO-DAF","Inclusion Criteria:\n\n* Age \\>=18\n* End stage renal failure on peritoneal dialysis or haemodialysis\n* documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation;\n* CHADS2-VASc \\>=2\n* The patient is willing and able to comply with the required medication post-procedure and follow-up evaluations;\n* Able to consent\n\nExclusion Criteria:\n\n* Patients who require long-term anticoagulation for a condition other than AF, e.g. pulmonary embolism, deep vein thrombosis, anti-phospholipid syndrome\n* Mechanical valve replacement\n* Active infection with bacteraemia;\n* Pregnant or nursing patients and those who plan pregnancy during the study period. Female patients of childbearing potential must have a negative pregnancy\n* Known hypersensitivity or contraindication to aspirin, clopidogrel, heparin, any device material or component (nickel titanium, PET, polypropylene), and\u002For contrast;\n* Left atrial appendage is obliterated and surgical ligated;\n* Underwent any cardiac or non-cardiac interventional or surgical procedure within 30 days prior to the procedure or planned to have the interventional or surgical procedure within 60 days after implant procedure (e.g., cardioversion, ablation, percutaneous coronary intervention, etc.);\n* Recent (within 90 days prior to procedure) stroke, transient ischemic attack, or myocardial infarction;\n* New York Heart Association Class IV;\n* Life expectancy is less than 1 year;\n* Current participation in another investigational drug or device study.\n* Echocardiogram exclusion:\n\n  i. Moderate mitral stenosis or above ii. LVEF \\\u003C30% iii. Intracardiac thrombus iv. Presence of a cardiac tumour. v. Existing circumferential pericardial effusion \\>5 mm; vi. Presence of a high-risk Patent Foramen Ovale (PFO), defined as an atrial septal aneurysm (excursion \\>15 mm or length \\>15 mm) or large shunt (early, within 3 beats and\u002For substantial passage of 20 bubbles)",{"count":294,"type":20},40,"1 Year","Objectives: This pilot study aims to evaluate the safety and efficacy of left atrial appendage occlusion (LAAO) in dialysis patients and atrial fibrillation (AF) to establish a novel stroke prevention strategy and determine an optimal post-occlusion antithrombotic regime. Page 3 of 50 Hypothesis: The study tests the hypotheses that LAAO is safe for dialysis patients, that a single antiplatelet regimen postprocedure is safe, and that LAAO effectively reduces the composite endpoint of stroke\u002Ftransient ischemic attack and major bleeding compared to standard care. Instruments: The study employs a multicenter, single-arm prospective registry design. Eligible participants, aged ≥18 with documented AF and ESRF on peritoneal dialysis (PD) or hemodialysis (HD), will undergo LAAO using the Watchman Flx PRO device. Propensity score matched historical cohort from dialysis registry will be identified for comparison.\n\nMain Outcome Measures: The primary endpoint is the composite of stroke\u002Ftransient ischemic attack\u002Fsystemic embolism and non-procedural-related major bleeding at one year. Secondary endpoints include individual rates of these events, procedural safety and device occlusion effectiveness. Data Analysis and Expected Results: Statistical analysis will involve descriptive statistics, chi-squared tests, and propensity score matching. A p-value of \\\u003C0.05 will be deemed significant. The pilot study anticipates a low peri-procedural complication rate (≤5%) and confirms LAAO's efficacy in stroke and major bleeding reduction in Chinese PD and HD patients compared to standard care. This data will inform the design of a larger randomized controlled trial aimed at validating LAAO as a safe alternative for AF management in dialysis populations.",[28,298,299,300,301,302],"Chronic Kidney Disease (Stages 3b-5)","Atrial Fibrillation","End Stage Kidney Failure","Stroke Prevention in Patients With Atrial Fibrillation","Left Atrial Appendage Occlusion","2025-12-02",{"date":305,"type":40},"2025-12-04",{"date":277,"type":20},{"date":308,"type":20},"2028-07-05",{"name":310,"class":47},"Prince of Wales Hospital, Shatin, Hong Kong",{"id":312,"slug":313,"hasResults":11,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":317,"eligibilityCriteria":318,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":319,"targetDuration":4,"studyType":21,"phases":321,"briefSummary":322,"conditions":323,"keywords":327,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":48},"100593956","wise-choices-in-the-intensive-care-unit-100593956","NCT07013175","Wise Choices in the Intensive Care Unit","WIse CHoices in the Intensive Care Unit, a Cluster Randomized Registry Based Clinical Trial","WICH-ICU","Inclusion Criteria:\n\n* Patients 18 years or older, treated in Swedish ICU's\n\nExclusion Criteria:\n\n* Patients under the age of 18 years",{"count":320,"type":20},10000,[89],"Aim: to evaluate if the Choosing Wisely campaign can be introduced without harming critically ill patients.\n\nBackground: Each year, around 45,000 patients are admitted to Sweden's 81 ICUs (intensive care units), costing 6-7 billion SEK (6% of total healthcare expenditure). The high costs of health care are partly attributable to overuse of diagnostic tests. Up to 30% of these tests lead to treatments that provide no benefit for patients, some of them may even be harmful(1-3). To improve quality of care while combating this problem of cost, the American Board of Internal Medicine Foundation developed the Choosing Wisely Campaign, tasking professional societies to develop lists of top five medical services patients and physicians should question. Patients in the ICU, can especially benefit from this paradigm shift. They are subjected to multiple testing on a daily - sometimes hourly - basis, therefore this field of medicine responded to the campaign quickly. Two sets of top-five-lists of tests and interventions that can be questioned have been published(4 5).\n\nIn multiple countries, including Sweden, the Choosing Wisely campaign is gathering traction among critical care physicians and is on the verge of being introduced. It is both common-sensical and will save money, so health care leaders are positive. However, the investigators have an opportunity, and a duty, to assess the evidence; can the Choosing Wisely campaign be introduced without harming ICU patients?\n\nThe present study thus aims to evaluate the introduction of the Choosing Wisely campaign in the context of the ICU. Is this change of care strategy associated with changes in 30-day-mortality? Secondary outcomes include ICU length of stay, use of non-invasive- or invasive mechanical ventilation and continuous renal replacement therapy. This is a registry-based cluster randomized controlled study (R-RCT), targeting Swedish ICU's across multiple regions. Primary and secondary outcomes will be retrieved from the Swedish Intensive care Register (SIR), making ICU participation easier and less costly.",[324,325,326,28,206],"Critical Illness","Ventilation","Outcome",[328,329],"critical illness","choosing wisely","2025-11-24",{"date":303,"type":40},{"date":333,"type":40},"2025-11-03",{"date":335,"type":20},"2027-12-31",{"name":337,"class":47},"Karolinska Institutet",{"id":339,"slug":340,"hasResults":11,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":344,"eligibilityCriteria":345,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":346,"targetDuration":4,"studyType":21,"phases":348,"briefSummary":349,"conditions":350,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":363,"completionDateStruct":364,"leadSponsor":366,"locationsCount":77},"100611239","protein-supplementation-during-dialysis-prosed-100611239","NCT07237997","Protein Supplementation During Dialysis (PROSED)","Re-examining Nutrition in Dialysis Patients: Nutritional Losses and the Role of Supplementation (Part 2).","PROSED","Inclusion Criteria:\n\n* Age ≥ 18 years (no upper age limit)\n* Patients receiving maintenance dialysis for ≥ three months\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Anticipated live donor kidney transplant and\u002For kidney recovery within the period of sample collection.\n* Anticipated change of dialysis modality within the period of sample collection\n* Severe malnutrition based on either:\n\n  * Renal 7-point Subjective Global Assessment (SGA) scores of 1-2\n  * Global Leadership Initiative Malnutrition (GLIM) Stage 2\n* Protein-losing enteropathy.\n* Persistent nephrotic syndrome with \\>3g\u002Fday urinary protein loss.\n* Active wounds or burns contributing to protein losses as judged by the investigator.\n* Current active acute inflammatory illness (likely to have catabolic effect in the opinion of the investigator).\n* Current malignancy based on recent (\\\u003C12 months) diagnosis and\u002For active treatment for malignancy and\u002For planned treatment for malignancy, excluding non-melanoma skin cancers.\n* Pregnancy (current or planned within duration of study) or breast feeding.\n* People with swallowing difficulties precluding safe ingestion (International Dysphagia Diet Standardization Initiative (IDDSI) level 0 thin fluid).\n* People receiving intradialytic parenteral nutrition or intra-peritoneal amino acids, or any other forms of artificial feeding\n* People prescribed levodopa\n* People who are receiving chronic glucocorticoid therapy (\\>10mg day prednisolone or equivalent for \\>7 days within preceding 90 days).\n* People who are consuming a protein dietary intake above 1.5g protein\u002Fkg\u002Fbody weight.\n* People who, in the opinion of the investigator, will be unable to comply with study protocol requirements.\n* People who are vegan or other religious based dietary restrictions which would prevent them taking the supplement.",{"count":347,"type":20},114,[89],"When a patient has dialysis some nutrients are lost in the process. Nutritional losses include protein, trace elements (i.e. zinc, copper and selenium) and water-soluble vitamins (Vitamins C and B). These nutrients are essential for normal body function, including a good immune system and nutritional status. For example, on average the protein losses during a dialysis session (the process where the blood is cleaned via a machine and special fluid) is equal to 6g of protein\u002Fday (which is the equivalent of the amount of protein in 1 egg). Protein needs for the general population are 0.8g protein per kg of body weight. Because people on dialysis lose protein via the dialysis, it is thought that these people need to eat more protein. Currently, in clinical practice for people receiving dialysis, the guidelines are to aim for 1.1 -1.4g of protein per kg of body weight. However, the research is old and very weak.\n\nDialysis treatments have changed over the past 40 years, and the investigator does not know if the replacement of these nutritional losses is important to how well people do on dialysis and if they have any effect on survival. Previous research is mostly limited to haemodialysis (a type of dialysis that requires a machine which cleans the patients' blood via special filters) and peritoneal dialysis (this is a type of dialysis which happens via the patients' tummy). There is no research on the nutritional supplementation in home HD and nocturnal HD. Our research will investigate if a higher protein provision leads to a reduction is hospital admissions and improved outcomes in patients receiving dialysis.",[351,28,352,353,354,355,356,357,358,359],"Dialysis Patients","Protein Energy Wasting","Protein Intake","High Protein Dietary Intake","Diet","Diet Therapy","Hospitalisation","Muscle Mass and Strength","Muscle Mass","2025-11-14",{"date":362,"type":40},"2025-11-20",{"date":277,"type":20},{"date":365,"type":20},"2029-10-30",{"name":367,"class":47},"University of Nottingham",{"id":369,"slug":370,"hasResults":11,"nctId":371,"briefTitle":372,"officialTitle":372,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":374,"targetDuration":4,"studyType":21,"phases":375,"briefSummary":376,"conditions":377,"keywords":378,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":4},"100597557","the-effects-of-a-dialysis-specific-formula-rich-in-branched-chain-amino-acids-omega-3-and-dietary-fiber-on-nutritional-status-100597557","NCT07060040","The Effects of a Dialysis-Specific Formula Rich in Branched-Chain Amino Acids, Omega-3, and Dietary Fiber on Nutritional Status","Inclusion Criteria:\n\n* Patients with ESRD who have been receiving dialysis for more than three months\n* Serum albumin (Alb) ≤ 4.0 g\u002FdL, or body mass index (BMI) ≤ 20, or normalized protein catabolic rate (nPCR) ≤ 0.8\n* Male or female patients aged 20 years or older\n\nExclusion Criteria:\n\n* Serum albumin (Alb) \\\u003C 3.0 g\u002FdL\n* Known allergy or intolerance to any component of the product, or deemed by a physician to be unable to complete the trial\n* Patients who refuse to sign the informed consent form or are unable to follow study instructions\n* Pregnant or breastfeeding women\n* Patients with severe illnesses (including burn injuries), undergoing major surgery, with abnormal liver function (GOT and GPT levels more than 5 times the upper limit of normal), or with malignancy (6) Participation in another clinical trial of investigational drugs or concurrent use of investigational drugs within 30 days prior to or during this trial (7) Any other serious medical condition as determined by the investigator that would make the patient unsuitable for participation",{"count":19,"type":20},[89],"The aim of this study is to evaluate the effects of a specialized oral nutritional supplement (SF) enriched with BCAAs, omega-3 fatty acids, and dietary fiber on improving the nutritional status of dialysis patients with mild to moderate malnutrition, and thereby alleviating fatigue and enhancing quality of life. We will assess various aspects of protein-energy wasting (PEW), as well as changes in the Malnutrition Inflammation Score (MIS), Geriatric Nutritional Risk Index (GNRI), fatigue, appetite, serum BCAA levels, uremic toxins, and gut microbiota composition.",[243,28],[379,380,381,382,383,66],"Branched-chain amino acid","Protein-energy malnutrition","fiber","omega-3","oral nutritional supplements","2025-07-01",{"date":386,"type":40},"2025-07-11",{"date":388,"type":20},"2025-07",{"date":390,"type":20},"2027-12",{"name":392,"class":47},"Buddhist Tzu Chi General Hospital",{"id":394,"slug":395,"hasResults":11,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":4,"eligibilityCriteria":399,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":400,"enrollmentInfo":401,"targetDuration":403,"studyType":57,"phases":4,"briefSummary":404,"conditions":405,"keywords":408,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":77},"100477480","the-kidneycare-community-access-to-research-equity-study-100477480","NCT05497518","The KidneyCARE (Community Access to Research Equity) Study","The KidneyCARE (Community Access to Research Equity) Study: A National Registry for People With All Stages of Kidney Disease (Formerly National Kidney Foundation Patient Network)","Inclusion Criteria:\n\n* Patients with any stage of CKD, including kidney transplant recipients and patients on dialysis.\n* Age 18 years and above.\n* Willing to participate in the Study and complete the informed consent form and assent form (where applicable).\n* Able to participate in this Study, which initially will be in English and then eventually expand to other languages.\n* Patients affiliated with Geisinger Health System must have given their consent to Geisinger Health System IRB to be contacted for research projects.\n\nExclusion Criteria:\n\n* Patient not diagnosed with CKD\n* Age below 18 years\n* Not willing to participate in the Study as well as unwilling to complete the informed consent form","120 Years",{"count":402,"type":20},50000,"50 Years","For chronic kidney disease (CKD), there is a lack of unique and powerful platform for patient engagement, research studies and public health advocacy work. The National kidney Foundation (NKF) launched the first nationwide registry for people at all stages and types of CKD, including people on dialysis and kidney transplant recipients, called the KidneyCARE Study (kidneycarestudy.org). The KidneyCARE Study is a non-interventional research study which means participants will not have to take medications or do any additional tests to participate. They are simply asked to share some personal and health information, and their experiences with their disease through a secure portal. The Study also collaborates with health systems to obtain additional electronic health records (EHR) data. This unique combination of data collected will address the gap of individualized educational resources and will enhance clinical research, clinical care, and health policy decisions to be centered on the patient. The Study is all online and can be accessed any time of day at kidneycarestudy.org. Participation is voluntary and free.",[406,28,407],"Chronic Kidney Disease","Kidney Transplant",[97,28,409,410,411,412,413],"Kidney transplant","Patient registry","Hereditary nephropathy","Genetic kidney disease","Rare kidney disease","2025-05-07",{"date":416,"type":40},"2025-05-13",{"date":418,"type":40},"2021-02-25",{"date":420,"type":20},"2070-02-24",{"name":422,"class":47},"Tufts Medical Center",{"id":424,"slug":425,"hasResults":11,"nctId":426,"briefTitle":427,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":429,"targetDuration":4,"studyType":21,"phases":430,"briefSummary":431,"conditions":432,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":77},"100535342","does-virtual-reality-improve-symptom-burden-in-dialysis-patients-100535342","NCT06250582","Does Virtual Reality Improve Symptom Burden in Dialysis Patients?","Inclusion Criteria:\n\n* Older than 18 years;\n* in treatment with thrice-weekly hemodialysis sessions;\n* regular hemodialysis duration of three to five hours\n* having no visual impairment\n* having no acoustic deficit\n* patient must be capable of speaking and understanding German or English\n* no signs of cognitive impairment\n* patient oriented in time and space\n* being able to give informed consent as documented by signature\n\nExclusion Criteria:\n\n* diagnosis of epilepsy\n* current pregnancy",{"count":5,"type":20},[89],"The goal of this clinical trial is to investigate the use of virtual reality therapy in dialysis patients. The main question it aims to answer is: Does virtual reality improve symptom burden in dialysis patients and improve their mental wellbeing? Over a period of one month, one virtual reality therapy session of 30 minutes will be performed during each regular hemodialysis session. Since we will conduct a monocentric, crossover randomized controlled trial, the participants act as their own control group.",[28,433],"Virtual Reality","2025-04-23",{"date":436,"type":40},"2025-04-27",{"date":438,"type":40},"2024-12-02",{"date":440,"type":20},"2025-12-31",{"name":442,"class":47},"David Blum",{"id":444,"slug":445,"hasResults":11,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":4,"eligibilityCriteria":449,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":450,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":452,"conditions":453,"keywords":455,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":77},"100581076","behind-the-needle-healthcare-professionals-perspectives-on-hd-needling-100581076","NCT06845605","Behind the Needle: Healthcare Professionals' Perspectives on HD Needling","A Qualitative Exploration Study of Healthcare Professionals' Perspectives in Haemodialysis Needling to Enhance Patients' Overall Experience","Inclusion Criteria:\n\n* Participants must be registered nurses or Band 3 healthcare assistants who perform needling procedures in a haemodialysis unit.\n* Participants must be employed at the renal dialysis units of East and North Hertfordshire NHS Trust (ENHT), including both the main unit and its satellite units.\n* Participants must be willing to participate in the study and share their experiences.\n* Participants must be able to speak English fluently to ensure they can communicate effectively, providing rich and comprehensive information.\n\nExclusion Criteria:\n\n•Registered nurses or healthcare assistants who do not perform needling procedures in a haemodialysis unit will not be eligible to participate.",{"count":451,"type":20},16,"Haemodialysis is essential for patients with End-Stage Renal Disease (ESRD), requiring consistent vascular access through arteriovenous fistulas or grafts. This involves frequent needling, a procedure that is painful and distressing for many patients, causing significant emotional and physical demands on healthcare professionals working in the dialysis units. In the UK, about 30,000 patients receive haemodialysis, involving over 300 needling procedures annually.\n\nHealthcare professionals (Registered nurses and healthcare assistants) play a crucial role, with their expertise directly affecting patient outcomes. However, 60% of HCPs (healthcare professionals) report high job-related stress, particularly due to needling demands. Effective needling requires not only technical proficiency but also managing patient pain and anxiety. Strong staff-patient relationships, characterized by empathy and understanding, can enhance the needling experience. Challenges for dialysis unit staff includes the technical difficulty of needling and the emotional burden of patient care. Studies highlight the need for better training and support systems to help them cope with these demands.\n\nUnderstanding healthcare professionals' perspectives can identify areas for improvement, inform training programs, and improve experiences in dialysis units. Research by Rahmah et al. (2018) and Duncanson (2023) emphasizes the importance of HCPs skills and the psychological toll on them, suggesting further exploration of this area is needed. The primary aim of this research is to examine HCPs perspectives on the needling experience in haemodialysis, aiming to identify improvement areas and inform targeted training programs to enhance patient experiences. The study will utilize a qualitative exploratory design with semi-structured interviews to gather in-depth insights from HCPs. Data will be collected from renal dialysis units at East and North Hertfordshire NHS Trust, involving 12 to 16 registered nurses performing needling procedures. Thematic analysis will be used to analyse interview transcripts and identify key themes related to technical skills, communication barriers, and patient-related factors. The study will run for 10 months.",[454,28],"Perspective of Healthcare Professionals Haemodialysis Needling",[456,457,152,458,459],"Haemodialysis","Haemodialysis needling","Fistula","Cannulation","2025-02-24",{"date":462,"type":40},"2025-02-25",{"date":464,"type":40},"2024-10-30",{"date":466,"type":20},"2025-05",{"name":468,"class":169},"East and North Hertfordshire NHS Trust",{"id":470,"slug":471,"hasResults":11,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":4,"eligibilityCriteria":475,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":476,"enrollmentInfo":477,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":479,"conditions":480,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":484,"lastUpdatePostDateStruct":485,"startDateStruct":487,"completionDateStruct":489,"leadSponsor":491,"locationsCount":77},"100580555","cgm-in-icodextrin-pd-100580555","NCT06838819","CGM in Icodextrin PD","Evaluation of Accuracy of Medtronic Simplera™ CGM in Patients on Icodextrin-containing Peritoneal Dialysis Regimens","Inclusion Criteria:\n\n1. Type 1 or 2 diabetes mellitus for at least 3 months\n2. On continuous ambulatory peritoneal dialysis (CAPD) or APD for at least 2 months\n3. On icodextrin PD solutions for at least 1 month or planned for switching to icodextrin PD solutions within 3 months of screening\n4. Male or female age ≥ 18 years old and ≤ 75 year old.\n5. Women who are not pregnant, lactating or planning a pregnancy during their participation in the clinical study.\n6. Willingness, ability and commitment to comply with the testing, procedure and follow-up outlined in this protocol including (but not limited to) frequency of clinic visits and use of pre-specified glucose monitoring devices.\n7. Willingness to abstain from swimming during their participation in the measurement phase.\n8. In the opinion of the investigator, absence of any physical limitations, addictive diseases, or underlying medical conditions (including mental health) that may preclude the patient from being a good study candidate.\n9. Written informed consent to participate in the study provided by the patient.\n\nExclusion Criteria:\n\n1. Poorly controlled diabetes mellitus with HbA1c\\>11%\n2. Peritonitis within 1 month of screening\n3. Planned for switching to hemodialysis or living donor transplant in the future 1 month\n4. Currently pregnant, as demonstrated by a positive pregnancy test at screening for women of reproductive potential\n5. Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.\n6. Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.\n7. Current use or recent exposure to any medication that in the opinion of the investigator could have an influence on the patient's ability to participate in this study or on the performance of the test device.\n8. Extensive skin changes\u002Fdiseases that preclude wearing the required number of devices on normal skin at the proposed application sites (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis).\n9. Have a known allergy to medical-grade adhesives, or known hypersensitivity to any of the products used in the study.\n10. Blood donation of more than 500 ml within the last three months\n11. Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection.\n12. Has a MRI scan, CT scan, or diathermy scheduled during the proposed study participation.\n13. An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).\n14. Women of reproductive potential who are unwilling to adopt contraceptive measures during the study period\n15. Patients with history of pacemaker and prosthesis implantation.\n16. Continuous use of real-time CGM for personal diabetes management in the three months prior to screening (sensor use \\>80% of time)","75 Years",{"count":478,"type":20},30,"Assessment of performance (precision and accuracy) of Simplera™ CGM as compared with a gold standard reference laboratory method (YSI glucose) in diabetes patients on peritoneal dialysis with icodextrin",[481,482,28,483],"Diabetes Mellitus (Diagnosis)","End Stage Renal Disease (ESRD)","Continuous Glucose Monitoring","2025-02-17",{"date":486,"type":40},"2025-02-21",{"date":488,"type":20},"2025-02-20",{"date":490,"type":20},"2026-09-20",{"name":492,"class":47},"Elaine Chow",{"id":494,"slug":495,"hasResults":11,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":499,"eligibilityCriteria":500,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":501,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":502,"conditions":503,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":505,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":77},"100577124","comparison-of-hemodialysis-techniques-in-the-removal-of-uremic-toxins-in-chronic-renal-failure-100577124","NCT06794216","Comparison of Hemodialysis Techniques in the Removal of Uremic Toxins in Chronic Renal Failure","Comparison of Expanded Hemodialysis With 3 Other Dialysis Techniques in the Removal of Uremic Toxins in Chronic Renal Failure","EMPIRE","Inclusion Criteria:\n\n* Age ≥18 years\n* Chronic hemodialytic treatment (on dialysis for at least 6 months), hemodialytic treatment with MCO filter (Theranova) or HF filter, OL- HDF or HFR with HFR filter17.\n* Continuous use of the same filter for at least 12 months.\n* Diuresis \\\u003C 200 ml\u002Fday.\n* Trisweekly hemodialysis treatment.\n* Session duration ≥ 210 minutes.\n* Availability of clinical data collected during the follow-up that took place at the O.U. of Nephrology, Dialysis and Transplantation - La Manna\n\nExclusion Criteria:\n\n* Intradialytic hypotension\n* Need for dialysis without heparin\n* Active bleeding\n* Active hematologic diseases\n* Thrombocytopenia\n* Chronic hepatopathies\n* Active systemic inflammatory diseases\n* Uncontrolled diabetes mellitus\n* Temporary vascular access\n* Recurrent vascular access infections",{"count":144,"type":20},"In recent years, expanded hemodialysis has been the subject of studies, many of them done on small populations, with limited observation periods and not always unambiguous results. In the literature, there are data comparing HDx and high-flow hemodialysis in terms of small- and medium-molecule purification and control of inflammation indices; there are fewer data comparing HDx and HDF online. In contrast, there are no studies in the literature comparing HDx with HFR. With a view to personalizing therapy, demonstrating the equivalence\u002Fsuperiority of HDx over the other dialysis techniques under consideration could make this technique suitable precisely for that class of more malnourished and more frail patients who to date do not obtain benefits from the other methods.\n\nThe objective of the study is the mid-term (12-month) evaluation and comparison of the MCO filter called Theranova 400™ (1.7 m2, steam sterilization, cut-off 25 Kda, Baxter, Heichingen, Germany) with high-flux hemodialysis (HF-HD), OL- HDF and hemodiafiltration with endogenous reinfusion (HFR) with HFR filter 17 , in combination with medical therapy under normal clinical practice, in terms of purification of low and medium molecular weight uremic toxins, control of baseline inflammatory status and erythropoietin resistance in patients with chronic renal failure undergoing hemodialysis treatment.",[28],"2025-01-24",{"date":506,"type":40},"2025-01-27",{"date":508,"type":40},"2024-03-01",{"date":510,"type":20},"2025-08-31",{"name":512,"class":47},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",{"id":514,"slug":515,"hasResults":11,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":519,"eligibilityCriteria":520,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":521,"targetDuration":4,"studyType":21,"phases":522,"briefSummary":523,"conditions":524,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":529,"startDateStruct":531,"completionDateStruct":532,"leadSponsor":534,"locationsCount":77},"100559212","functionality-of-albumin-in-the-context-of-hemodialysis-100559212","NCT06561191","Functionality of Albumin in the Context of Hemodialysis","Effects of Dialyzer Characteristics and Dialysis Mode on Functional Properties of Albumin in Patients With Chronic Hemodialysis Treatment","FACED","Inclusion Criteria:\n\n* 18 years or older at least 3 month of hemodialysis treatment (3x\u002Fweek) with constant dialysis treatment regimen\n\nExclusion Criteria:\n\n* Age ≤ 18 years\n\n  * Less than three months of regular (3x\u002Fweek) hemodialysis treatments or less than 3 treatments\u002Fweek\n  * Acute or chronic liver disease (Child stage A or higher or fulfillment of the of the Kings College criteria)\n  * Infusion of commercial human albumin (e.g. in the context of ascites drainage) in the last three months prior to study inclusion\n  * Acute or severe chronic infections\n  * Acute tumor disease",{"count":144,"type":20},[89],"Hemodialysis treatment enables patients with end-stage chronic kidney disease to survive. At the same time, however, this treatment also increases cardiovascular mortality, in particular due to a chronically increased level of inflammation and usually incomplete removal of uraemic toxins. Both of these are closely linked with the functional properties of albumin.\n\nThe aim of this study is to investigate the effects of various parameters of dialysis, in particular dialyzer properties and dialysis mode on the functional properties of albumin and to what extent these parameters can be used therapeutically, to improve the treatment quality of hemodialysis treatment in the long term by modifying albumin functional properties.\n\nOur own preliminary work in this field and the current state of research indicate that, for example, the use of high-flux dialyzers can contribute to a reduction of the oxidative stress level. It also appears possible that treatment mode (haemodiafiltration instead of haemodialysis) may also have an effect on the binding and detoxification efficiency of albumin and thus on the removal of uraemic toxins.\n\nPrevious results have mostly been collected in observational studies. As a proof-of-concept study, this study will further investigate the concrete therapeutic applicability in an interventional study design.",[525,28,526,527],"Albumin","Redox State","Uremic; Toxemia","2024-08-17",{"date":530,"type":40},"2024-08-19",{"date":281,"type":40},{"date":533,"type":20},"2025-12",{"name":535,"class":47},"Universität Duisburg-Essen",{"id":537,"slug":538,"hasResults":11,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":4,"eligibilityCriteria":542,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":543,"targetDuration":545,"studyType":57,"phases":4,"briefSummary":546,"conditions":547,"keywords":550,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":556,"startDateStruct":558,"completionDateStruct":560,"leadSponsor":562,"locationsCount":77},"100557738","an-evaluation-of-the-kccq-score-in-predicting-cardiovascular-risk-in-dialysis-patients-100557738","NCT06542016","An Evaluation of the KCCQ Score in Predicting Cardiovascular Risk in Dialysis Patients","A Prospective Study on Predicting Cardiovascular Events and Mortality Risk in Maintenance Dialysis Patients Based on Changes in KCCQ Scores","Inclusion Criteria:\n\n1. Age 18 or older with no restrictions on gender or ethnicity;\n2. All enrolled patients meet the diagnostic criteria for CKD stage 5 according to the KDOQI guidelines of the National Kidney Foundation;\n3. Newly diagnosed uremia patients planning to start maintenance dialysis (hemodialysis or peritoneal dialysis), as well as patients currently undergoing maintenance dialysis treatment (hemodialysis or peritoneal dialysis);\n4. Clear contact information is available to reach patients or family members for follow-up;\n5. Signed informed consent and ability to complete the KCCQ.\n\nExclusion Criteria:\n\n1. Patients with acute kidney injury from various causes;\n2. Patients with severe mental illnesses that affect their ability to complete questionnaires;\n3. Patients who have had acute myocardial infarction, coronary artery stent implantation, coronary artery bypass grafting (CABG) or pacemaker implantation within the past three months;\n4. Patients with special types of heart disease, including cardiac amyloidosis, congenital heart disease and pericardial diseases;\n5. Patients with chronic lung diseases;\n6. Patients with serious underlying conditions such as severe infections, tumors or severe liver diseases;\n7. Patients scheduled for kidney transplantation.",{"count":544,"type":20},136,"12 Months","Cardiovascular Disease (CVD) is the main complication and the most important cause of death in CKD patients. As the disease progresses, the incidence of cardiovascular disease in CKD patients gradually increases, especially in End-Stage Renal Disease (ESRD) patients receiving dialysis treatment, where the prevalence of cardiovascular disease reaches its highest level. Currently, there is a lack of a simple and reliable tool to assess the cardiac function status and predict the risk of cardiovascular events in patients on maintenance dialysis. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a widely used patient-reported outcomes measurement tool for assessing health-related quality of life in heart failure patients. It has been shown that KCCQ scores not only reflect the underlying undiagnosed symptoms of heart failure in CKD patients, but also have a strong correlation with prognosis. However, there is currently insufficient clinical evidence to confirm the value of the KCCQ in patients on maintenance dialysis.\n\nInvestigators will perform a prospective, single-center, observational study to collect the changing trend of KCCQ scores at baseline and during the observation periods in maintenance dialysis patients, to analyze the association between the scores and the occurrence of long-term cardiovascular events and all-cause mortality. The aim is to construct a predictive model of KCCQ scores to provide a reference basis for clinical management of this high-risk group, so as to optimize the diagnosis and treatment of heart failure in dialysis patients and improve their cardiovascular outcomes.",[548,28,549],"Chronic Kidney Disease Stage 5","Heart Failure",[548,551,549,552,553,554],"Maintenance Dialysis","Cardiovascular Outcomes","Kansas City Cardiomyopathy Questionnaire","patient self-reported outcomes","2024-08-02",{"date":557,"type":40},"2024-08-07",{"date":559,"type":40},"2024-07-01",{"date":561,"type":20},"2026-07-01",{"name":563,"class":47},"Shenzhen Second People's Hospital"]