[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Dr. F. Köhler Chemie GmbH\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":67},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100518565","phase-2-study-of-organ-perfusion-in-heart-transplantation-in-children-100518565",false,"NCT06032195","Study of Organ Perfusion in Heart Transplantation in Children","A Prospective Randomized Single Blind Multicenter Phase II Study of Organ Perfusion With Custodiol-N Compared With Custodiol in Heart Transplantation in Children","Inclusion Criteria:\n\n* Age from birth to less than18 years\n* Recipients awaiting their first transplant\n* Ability of the patients and\u002F or their legal guardians to understand character and individual consequences of the clinical trial\n* written informed consent of the patients and\u002F or their legal guardians (must be available before enrolment in the study)\n* Patient listed on the waiting list for heart transplantation\n\nExclusion Criteria:\n\n* Patients who have participated within 30 days or are still participating in any other interventional studies\n* history of severe organic disease other than concerning the heart\n* history\u002Fdemonstration of HIV antibodies or AIDS\n* multiorgan transplantation\n* machine-perfused organ\n* the explantation team is affiliated to another clinic than transplantation team\n* Failing Fontan patients\n* Patients who have been incarcerated or involuntarily institutionalized by court order or by the authorities\n* Pregnancy and lactation","ALL","24 Hours","17 Years",{"count":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this prospective randomized single blind multicenter phase II study is to compare organ perfusion with Custodiol-N and Custodiol in heart transplantation in children of all ages (birth to \\\u003C18 years) being listed on the waiting list for heart transplantation. The main question it aims to answer is:\n\nto compare the safety of Custodiol-N in heart transplantation in children in comparison to its precursor product Custodiol.\n\nParticipants will receive either a heart to be transplanted, either perfused with Custodiol-N or Custodiol to Researchers will compare the two solutions to see if the new solution Custodiol-N is safe in heart transplantation in children.",[27],"Heart Transplantation","RECRUITING","2026-01-28",{"date":31,"type":32},"2026-01-30","ACTUAL",{"date":34,"type":32},"2023-08-15",{"date":36,"type":21},"2027-09",{"name":38,"class":39},"Dr. F. Köhler Chemie GmbH","INDUSTRY",3,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100333874","phase-3-custodiol-n-solution-compared-with-custodiol-solution-in-organ-transplantation-kidney-liver-and-pancreas-100333874","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","18 Years",{"count":50,"type":21},362,[52],"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",[55,56,57],"Kidney Failure","Liver Failure, Chronic","Kidney-Pancreas Failure","2025-09-03",{"date":60,"type":32},"2025-09-10",{"date":62,"type":32},"2019-05-23",{"date":64,"type":21},"2028-09-30",{"name":38,"class":39},4,""]