[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"peritoneal-dialysis-complication\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:peritoneal-dialysis-complication":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,45,78,104,131,154],{"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":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100494256","phase-3-mechanisms-and-safety-of-sglt2-inhibition-in-peritoneal-dialysis-100494256",false,"NCT05715814","meChANisms and sAfety of SGLT2 Inhibition in peRitoneal dialYsis","A Single Arm, Open Label, Pilot Study to Evaluate the Safety and Efficacy of Once Daily 25mg Empagliflozin in Patients on Peritoneal Dialysis With Residual Kidney Function","CANARY","Inclusion Criteria:\n\n* Signed and dated written informed consent.\n* Patients aged ≥18 years on PD with RKF defined as at least 250 cc of urine output per day (assessed via 24-hour urine collection) and a minimum measured GFR of 2 ml\u002Fmin\u002F1.73m2, as measured at least once in the last 3 months.\n* Stable PD prescription, as determined by investigators.\n* Stable dose of RAAS blockade if on a medication within this class for the last 30 days.\n\nExclusion Criteria:\n\n* Type 1 diabetes.\n* Recent (in the 30 days prior to screening) acute coronary syndrome or cerebrovascular event.\n* PD peritonitis within 30 days of screening.\n* History of organ transplant, including pancreas, pancreatic islet cells or kidney transplant.\n* Planned surgery\u002Fprocedures or radiologic investigations requiring contrast during the trial.\n* Pregnant, planning to become pregnant, or nursing an infant during the study period\n* History of any DKA event\n* Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells (e.g., malaria, babesiosis, hemolytic anemia) at screening.\n* Women who are pregnant, nursing, or who plan to become pregnant whilst in the trial.\n* Alcohol or drug abuse within the 3 months prior to screening that would interfere with trial participation based on Investigator's judgement.\n* Use of SGLT2 inhibitor within 30 days prior to screening.\n* Intake of an investigational drug in another trial within 30 days prior to screening.\n* Patient not able to understand and comply with study requirements, based on Investigator's judgment.\n* Any other clinical condition that, based on Investigator's judgement, would jeopardize patient safety during trial participation or would affect the study outcome (e.g. immunocompromised patients, active malignancy, patients who might be at higher risk of developing genital or mycotic infections, patients with chronic viral infections, uncontrolled hypertension, cardiorenal and\u002For hepatorenal syndrome, severe hepatic impairments etc.).","ALL","18 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The primary aim of this study is to determine the safety and mechanisms of SGLT2 inhibition in individuals on peritoneal dialysis (PD) with residual kidney function (RKF).",[27,28,29,30,31],"Peritoneal Dialysis Complication","End Stage Kidney Disease","Sodium-glucose Co-transporter-2 Inhibitors","Kidney Dysfunction","Residual Kidney Function","RECRUITING","2026-04-30",{"date":35,"type":36},"2026-05-01","ACTUAL",{"date":38,"type":36},"2024-09-01",{"date":40,"type":21},"2027-12-01",{"name":42,"class":43},"University Health Network, Toronto","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":17,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":56,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100201063","international-pediatric-peritoneal-biobank-100201063","NCT01893710","International (Pediatric) Peritoneal Biobank","Inclusion Criteria\n\n* Age 0 to 90 years\n* CKD 5D, peritoneal dialysis and\n* Patients with normal renal function and elective abdominal surgery due to limited abdominal pathology (such as hernia repair, gallstones….)\n* Patients post PD and post Tx\n* Oral and written consent\n* Ability to consent of the adult patient and of the parents and legal guardian of patients not yet of legal age, respectively\n\nExclusion Criteria:\n\n* Abdominal adhesions, malformation and inflammation beyond PD induced changes\n* Patients with disseminated tumour disease\n* Patients with critical heart failure and other medical conditions, where the additional procedure may confer an increased increase risk\n* Pregnancy\n* Preterm babies (below 37 weeks of gestational age)\n* Serum hemoglobin \\\u003C 10 g\u002Fdl in newborns and \\\u003C 8 g\u002Fdl in children and adults",true,"1 Day","90 Years",{"count":55,"type":21},500,"2 Years","OBSERVATIONAL","Within few years the peritoneal membrane of adult peritoneal dialysis (PD) patients undergoes substantial morphological transformation, including progressive fibrosis, vasculopathy and neoangiogenesis. Ultrafiltration capacity steadily declines and ultimately results in PD failure. In children, peritoneal biopsies demonstrating PD associated alterations have not yet been obtained. They, however, should be particularly informative, since secondary tissue and vascular pathology related to ageing or diabetes is absent.\n\nAn international, prospective peritoneal membrane biopsy study in children on PD will therefore be performed. Biopsies will be obtained at time of PD catheter insertion, on occasion of intercurrent abdominal surgery (e.g. hernia repair, catheter exchange) and at time of renal transplantation. Quantitative histomorphometry and tissue protein expression analyses will be correlated with time integrated PD treatment modalities and functional characteristics as well as inflammatory and cardiovascular comorbidity surrogate parameter. Blood will be obtained during clinical routine sampling. Biopsies will be obtained during clinically indicated operations, without substantially increasing operation time and associated surgical risks. The detailed histomorphometry of the PD membrane will give additional information, potentially impacting on the individual PD regime.\n\n3\u002F2018: The analyses of the pediatric PD biopsy demonstrated early and major transformation of the peritoneal membrane with neutral pH low GDP fluids, and significant vasculopathy already in children with CKD stage 5, further progressing with PD. The underlying mechanisms are partly understood, only. In view of these major findings and the numerous open questions, collection of biosamples will be continued in children and also in adult PD patients. The following questions will be addressed: Molecular counterparts of peritoneal semi-permeability, solute and water transport (beyond AQP1), pathomechanisms and molecular and functional impact of peritoneal transformation with low and high GDP fluids, and the respective pathomechanisms and molecular and functional impact of vascular disease in CKD and with different PD fluids. The impact of renal transplantation following PD will be assessed in a subgroup of patients with tenckhoff catheter removal several weeks after transplantation and a functioning graft.",[60,27,61,62],"Kidney Failure, Chronic","Transplantation","Healthy",[64,65,66,67,68],"peritoneal dialysis","parietal peritoneum","omentum","chronic kidney disease","vasculopathy","2026-04-29",{"date":33,"type":36},{"date":72,"type":36},"2011-02-01",{"date":74,"type":21},"2028-12-31",{"name":76,"class":43},"Heidelberg University",26,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":44},"100553206","phase-2-empagliflozin-on-residual-kidney-function-in-incident-peritoneal-dialysis-patients-100553206","NCT06483074","Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients","Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients: a Pilot Randomized Controlled Trial","EMPIRIC-PD","Inclusion Criteria:\n\n1. Incident PD patients within 90 days of Tenckhoff catheter insertion\n2. Age 18-75 years old\n3. Patient with or without history of Type 2 diabetes\n4. Residual GFR (defined as the average of 24-hour urinary urea and creatinine clearances) \\> 2ml\u002Fmin\u002F1.73m2 AND urine volume \\> 400ml per day\n5. Patients who are willing to provide written informed consent\n\nExclusion Criteria:\n\n1. Patients with history of hemodialysis (≥ 3 months) or renal transplant\n2. Life expectancy \\\u003C6 months\n3. Prior use of any type of SGLT2 inhibitors within 1 month before screening visit\n4. Poorly controlled diabetes with HBA1c \\>11%\n5. Type 1 diabetes\n6. History of any active malignancy within 5 years (except curatively resected basal cell or squamous cell skin cancers)\n7. Peritonitis within 4 weeks\n8. Ketoacidosis within 5 years\n9. Known hypersensitivity to empagliflozin or other SGLT2 inhibitors\n10. Any active acute or chronic physical or mental conditions that, in the opinion of the investigator, might interfere with the compliance of participants to or the performance of this study\n11. Participation in any clinical trial or use of any investigational medicinal product 1 month before screening visit","75 Years",{"count":88,"type":21},48,[90],"PHASE2","Empagliflozin, a new class of diabetes medication, has demonstrated a reduction in renal function decline among patients with chronic kidney disease, regardless of their diabetes status. However, all previous studies excluded dialysis patients. Patients starting dialysis may still produce a certain amount of urine. Importantly, patients with better preserved residual kidney function tend to have better control of blood pressure and volume status, improved nutrition status, higher quality of life and reduced mortality rate.\n\nThe purpose of this study is to learn about the safety of empagliflozin in patients on peritoneal dialysis, in preparation for a future large clinical trial. Participants who newly initiate peritoneal dialysis will be randomly allocated to either empagliflozin on top of standard of care, or standard of care alone. Over a follow-up period of six months, the investigators will collect information on urine volume, blood pressure and glucose control. Safety, tolerability and drug compliance of empagliflozin will also be evaluated. If empagliflozin is found to be safe and well tolerated in patients on peritoneal dialysis, further large-scale randomized controlled trial may be conducted to evaluate its impact on residual kidney function and other relevant clinical outcomes.",[93,27,94,31],"End Stage Renal Disease on Dialysis","Sodium-glucose Cotransporter-2 Inhibitor","2025-08-02",{"date":97,"type":36},"2025-08-06",{"date":99,"type":36},"2024-07-29",{"date":101,"type":21},"2026-10-31",{"name":103,"class":43},"Chinese University of Hong Kong",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":4},"100519615","phase-3-safety-and-efficacy-of-apixaban-versus-warfarin-in-peritoneal-dialysis-patients-with-non-valvular-atrial-fibrillation-a-prospective-randomised-open-label-blinded-end-point-trial-apidp2-100519615","NCT06045858","Safety and Efficacy of Apixaban Versus Warfarin in Peritoneal Dialysis Patients With Non Valvular Atrial Fibrillation: a Prospective, Randomised, Open-label, Blinded End-point Trial (APIDP2)","APIDP2","Inclusion criteria\n\n* Males and females, age at least 18 years, in ESRD treated with peritoneal dialysis for ≥ 3 months\n* Patients with a history of non valvular AF treated by oral anticoagulation or patients initiating oral anticoagulation for a diagnosis of non valvular AF\n* CHA2DS2-VASc score of ≥ 2.\n* For women of childbearing age who are sexually active, use of an effective method of contraception for up to 10 days after the end of treatment and a negative blood pregnancy test at enrollment.\n* Signature of informed consent\n\nExclusion criteria\n\n* Not considered by the treating physician(s) to be candidates for oral anticoagulation (for example, hemoglobin \\\u003C8.5g\u002FdL, history of intracranial hemorrhage, active bleeding, recent gastrointestinal bleed or retroperitoneal bleed, severe hepatic impairment, or anaphylactic reaction to apixaban)\n* Moderate or severe mitral stenosis\n* Patients with a history of transient ischemic attack or stroke in the 3 months prior to inclusion\n* Patient treated with haemodyalisis\n* Conditions other than non valvular AF that require anticoagulation such as mechanical prosthetic valve, deep venous thrombosis, or pulmonary embolism\n* Life expectancy \\\u003C 3 months\n* Anticipated kidney transplant within the next 3 months\n* Individuals covered by Articles L1121-5 to L1121-8 of the French Public Health Code (corresponding to all protected persons: pregnant women, postpartum women, breastfeeding mothers, individuals deprived of their liberty by judicial or administrative decision, minors, individuals under legal protection such as guardianship or trusteeship).\n* Women of childbearing age not using a highly effective contraceptive method during the study and up to 10 days after the end of treatment.\n* Use of potent inducers of CYP3A4 (particularly rifampicin, phenytoin, carbamazepine, phenobarbital, or St. John's wort (Hypericum perforatum)).\n* Use of CYP3A4 and P-gp inhibitors, particularly azole antifungals (ketoconazole, itraconazole, voriconazole, posaconazole, fluconazole), HIV protease inhibitors, clarithromycin, and erythromycin.\n* Contraindication to anticoagulant treatment, such as antiphospholipid syndrome.",{"count":112,"type":21},178,[24],"Introduction:\n\nSeveral randomised controlled trials have demonstrated that novel oral anticoagulants (NOACs) are safer compared to vitamin K antagonists for the management of non valvular atrial fibrillation (NVAF) to prevent thromboembolic events, in the general population. There is a growing interest in the use of apixaban in patients with End-Stage Renal-Disease (ESRD) undergoing peritoneal dialysis but there is a lack of randomised data in this population.\n\nDesign: APIDP2 is a prospective parallel randomised, open-label, blinded endpoint trial.\n\nParticipants: Patients with ESRD undergoing chronic Peritoneal Dialysis who have NVAF.\n\nSetting: A total of 178 participants will be recruited from 20 French peritoneal dialysis centers.\n\nIntervention: Eligible patients will be randomly assigned to receive either apixaban at a reduced dose 2.5mg twice daily (dose determined with the previous pharmacokinetic study APIDP1 of apixaban in PD patients) or dose-adjusted to INR target \\[2-3\\] coumadin therapy. Anticoagulation to prevent thromboembolic events will be initiated or changed according to the randomisation for a duration of one year.\n\nThe primary outcome is a major or clinically relevant non-major bleeding from randomisation up to Month 12, assessed according to ISTH score. Secondary outcomes encompass an efficacy composite criterion combining stroke or TIA, cardiovascular death, and thrombosis including myocardial infarction cumulated at 12 months. Bleeding events will be also classified according to GUSTO and TIMI criteria and pharmacodynamics outcomes will evaluate the time within the INR target range of \\[2-3\\] in the warfarin arm over one year, and AntiXa apixaban activity in case of bleeding events and at 1, 6, and 12 months of follow-up in the apixaban arm.\n\nPrimary outcome analysis: To demonstrate that apixaban is safer than warfarin at one year, assuming two interim analyses after 60 and 118 patients, a bilateral alpha risk of 5% and a power of 80%, 178 patients are needed in this randomised trial (effect size found in the ARISTOTLE study among patients with CrCl \\[25-30\\]ml\u002Fmin), i.e. 89 patients per group.",[116,27],"Atrial Fibrillation",[64,118,119,120],"atrial fibrillation","anticoagulation","randomized controlled trial","NOT_YET_RECRUITING","2024-08-08",{"date":124,"type":36},"2024-08-09",{"date":126,"type":21},"2024-10-30",{"date":128,"type":21},"2027-10-30",{"name":130,"class":43},"University Hospital, Caen",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":86,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":140,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":44},"100546748","dapagliflozin-delays-the-loss-of-renal-function-in-peritoneal-dialysis-patients-100546748","NCT06398977","Dapagliflozin Delays the Loss of Renal Function in Peritoneal Dialysis Patients","Dapagliflozin Delays the Loss of Residual Renal Function in Patients Undergoing Peritoneal Dialysis: A Single-Center Randomized Open-Label Study","Inclusion Criteria:\n\n* Patients with PD duration between 1 month and 3 months.\n* Patients aged between 18 and 75 years.\n* Voluntary signing of informed consent.\n* Stable use of a maximum tolerated dose of RAAS inhibitors for one month if hypertension is present.\n* Daily urine output ≥ 400ml\u002Fday.\n* Stable PD prescription for one month.\n\nExclusion Criteria:\n\n* Pregnant and lactating women.\n* Patients with type 1 diabetes mellitus.\n* Patients with type 2 diabetes mellitus who have experienced diabetic ketoacidosis in the past.\n* Patients with chronic liver disease, including non-alcoholic fatty liver disease, cirrhosis, ALT \\> 120 IU\u002FL, and other clinically confirmed severe liver diseases.\n* Patients with more than 2 episodes of urinary tract infection in the past six months.\n* Patients with severe allergic reactions (rash or angioedema) to Dapagliflozin.\n* Patients using the following medications: rifampicin, phenytoin.\n* Patients with malignant tumors.\n* Patients who developed peritonitis within one month.\n* Patients undergoing combined hemodialysis treatment.\n* Patients with a willingness for kidney transplantation within six months.\n* Patients with a history of pancreatitis or pancreatic transplantation.\n* Patients who experienced acute coronary syndrome or cerebrovascular events within one month.\n* Hemoglobin level less than 90g\u002FL.",{"count":139,"type":21},70,[141],"NA","This study aims to explore the role of dagliflozin in preserving the residual renal function(RRF) in peritoneal dialysis (PD) patients.",[27,144,29],"Renal Function Aggravated","2024-04-30",{"date":147,"type":36},"2024-05-03",{"date":149,"type":36},"2024-03-11",{"date":151,"type":21},"2026-12-31",{"name":153,"class":43},"Sichuan Academy of Medical Sciences",{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":86,"enrollmentInfo":161,"targetDuration":4,"studyType":22,"phases":163,"briefSummary":164,"conditions":165,"keywords":4,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":4},"100525256","incremental-pd-with-single-icodextrin-exchange-100525256","NCT06119373","Incremental PD With Single Icodextrin Exchange","Initiation of Incremental Dialysis With Single Daily Icodextrin Exchange: a Randomized Controlled Trial","Inclusion Criteria:\n\n1. male or female patients aged 18 to 75 years;\n2. patients with chronic kidney disease stage 5 who are to start PD;\n3. eGFR ≥ 5 ml\u002Fmin;\n4. urine output ≥ 800 ml\u002Fd.\n\nExclusion Criteria:\n\n1. documented anaphylaxis with icodextrin or glucose-based dialysate;\n2. concomitant severe chronic diseases such as malignancy, hepatitis, severe cardiac diseases, etc.;\n3. ongoing severe infection;\n4. planned or ongoing pregnancy or lactation;\n5. currently enrolled in other clinical studies;\n6. patients who have a life expectancy of \\\u003C12 months;\n7. refusal to give a written consent.",{"count":162,"type":21},72,[141],"Objectives: To investigate the efficacy and safety of single daily icodextrin exchange for initiation of incremental peritoneal dialysis (PD).\n\nSubjects: Seventy-two incident PD patients.\n\nMethods: A single-center randomized controlled trial.\n\nPrimary outcome: Change in residual kidney function in 48 weeks after recruitment.",[27,31,166,167],"Survival","Health-related Quality of Life","2023-11-05",{"date":170,"type":36},"2023-11-08",{"date":172,"type":21},"2023-12-01",{"date":174,"type":21},"2026-11-30",{"name":176,"class":43},"RenJi Hospital"]