[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"liver-failure-chronic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:liver-failure-chronic":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100333874","phase-3-custodiol-n-solution-compared-with-custodiol-solution-in-organ-transplantation-kidney-liver-and-pancreas-100333874",false,"NCT03627013","Custodiol-N Solution Compared With Custodiol Solution in Organ Transplantation (Kidney, Liver and Pancreas)","A Prospective, Randomized, Single Blind, Multicentre Phase III Study on Organ Preservation With Custodiol-N Solution Compared With Custodiol Solution in Or-gan Transplantation (Kidney, Liver and Pancreas)","Inclusion Criteria:\n\n* All organs (kidney, combined kidney - pancreas and liver) Donor criteria\n\nFor All patients undergoing deceased donation:\n\n\\- deceased adult (≥18 years) donors fulfilling the criteria for organ donation\n\nFor All patients undergoing living kidney donation:\n\n\\- adult (≥18 years) living kidney donors fulfilling the criteria for organ donation\n\nPatient (recipient) criteria\n\n* recipients awaiting their transplant\n* recipients ≥18 years\n* recipients' signed informed consent before the transplantation Kidney \u002F combined kidney - pancreas recipients\n* n\u002Fa Liver recipient\n* full organ transplantation\n\nExclusion Criteria:\n\n* All organs (kidney, combined kidney - pancreas and liver) Donor criteria (not applicable for living kidney donors)\n* \\- donors whose organs are all allocated out of retrieving study center\n* general refusal of organ donation\n* donation after cardiac death (DCD) Patient (recipient) criteria\n* pregnant or lactating patients\n* recipients participating in any interventional study (e.g. another study involving compound\u002Finterventions aimed at the reduction of preservation and \u002F or ischemia \u002F reperfusion injury)\n* all combined allocations other than pancreas and kidney\n\nKidney \u002F combined kidney -pancreas recipient\n\n* double kidney transplantation\n* pancreas retransplantation\n* machine perfusion According to the KDIGO-Guidelines (2009) all patients with PRA \\>0% are only included in the living donation setting.\n\nLiver recipient\n\n* retransplantation\n* machine perfusion","ALL","18 Years",{"count":19,"type":20},362,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","Synopsis Title of Study A prospective, randomized, single blind multicentre phase III study on organ preservation with Custodiol-N compared with Custodiol solution in organ transplantation (kidney, liver and pancreas)\n\nProtocol number: CL-N-KLP-TX-III\u002F07-AT\u002F17\n\nTrial design The study design is a prospective, randomized, single blind, multicentre, phase III comparison study of organ perfusion intended to demonstrate non-inferiority of Custodiol-N against Custodiol in organ transplantation of kidney, combined kidney-pancreas and liver.\n\nIntended duration of study The overall duration for the trial is expected to be approximately 30 months. The du-ration of the trial for each subject is expected to be 3 months (transplantation and a follow-up period of 90 days).\n\nPurpose of the study\n\nThe objective of this investigation is to demonstrate non-inferiority of graft preservation with Custodiol-N compared to Custodiol with respect to both graft function and injury after transplantation of kidney, liver or combined kidney-pancreas.\n\nPatient selection The study population will be selected from patients who will undergo kidney, liver or combined kidney-pancreas transplantation. Patients of each gender will be included in the study.\n\nPlanned number of patients (recipients)\n\nIn total N=362 including:\n\nKidney 242 (including approx. 30 combined kidney-pancreas)\n\nLiver 120",[26,27,28],"Kidney Failure","Liver Failure, Chronic","Kidney-Pancreas Failure","RECRUITING","2025-09-03",{"date":32,"type":33},"2025-09-10","ACTUAL",{"date":35,"type":33},"2019-05-23",{"date":37,"type":20},"2028-09-30",{"name":39,"class":40},"Dr. F. Köhler Chemie GmbH","INDUSTRY",4]