[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100333874":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":11,"centralContacts":40,"locations":46,"responsibleParty":95,"collaborators":11,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":11,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":11,"enrollmentInfo":106,"targetDuration":11,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":11,"overallStatus":49,"whyStopped":11,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Dr. F. Köhler Chemie GmbH","INDUSTRY",[8,14,19,22,25,28],{"label":9,"type":10,"description":11,"interventionNames":12},"Kidney Custodiol-N","EXPERIMENTAL",null,[13],"Drug: Custodiol-N Solution",{"label":15,"type":16,"description":11,"interventionNames":17},"Kidney Custodiol","ACTIVE_COMPARATOR",[18],"Drug: Custodiol HTK Solution",{"label":20,"type":10,"description":11,"interventionNames":21},"Liver Custodiol-N",[13],{"label":23,"type":16,"description":11,"interventionNames":24},"Liver Custodiol",[18],{"label":26,"type":10,"description":11,"interventionNames":27},"Kidney\u002FPancreas Custodiol-N",[13],{"label":29,"type":16,"description":11,"interventionNames":30},"Kidney\u002FPancreas Custodiol",[18],[32,37],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":11},"DRUG","Custodiol-N Solution","Perfusion",[9,26,20],{"type":33,"name":38,"description":35,"armGroupLabels":39,"otherNames":11},"Custodiol HTK Solution",[15,29,23],[41],{"name":42,"role":43,"phone":44,"phoneExt":11,"email":45},"Astrid Friedel","CONTACT","+4332638578017","astrid.friedel@medunigraz.at",[47,62,73,84],{"facility":48,"status":49,"city":50,"state":11,"zip":11,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Medical University Graz","RECRUITING","Graz","Austria","AT",{"type":54,"coordinates":55},"Point",[56,57],15.44197,47.06733,{"lat":57,"lon":56},[60],{"name":61,"role":43,"phone":11,"phoneExt":11,"email":11},"Stiegler",{"facility":63,"status":49,"city":64,"state":11,"zip":11,"country":51,"countryCode":52,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Medical University Innsbruck","Innsbruck",{"type":54,"coordinates":66},[67,68],11.39454,47.26266,{"lat":68,"lon":67},[71],{"name":72,"role":43,"phone":11,"phoneExt":11,"email":11},"Schneeberger",{"facility":74,"status":49,"city":75,"state":11,"zip":11,"country":51,"countryCode":52,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Ordensklinikum Linz","Linz",{"type":54,"coordinates":77},[78,79],14.28611,48.30639,{"lat":79,"lon":78},[82],{"name":83,"role":43,"phone":11,"phoneExt":11,"email":11},"Biebl",{"facility":85,"status":49,"city":86,"state":11,"zip":11,"country":51,"countryCode":52,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Medical University Vienna","Vienna",{"type":54,"coordinates":88},[89,90],16.37208,48.20849,{"lat":90,"lon":89},[93],{"name":94,"role":43,"phone":11,"phoneExt":11,"email":11},"Berlakovich",{"type":96,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":107,"type":108},362,"ESTIMATED","INTERVENTIONAL",[111],"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",[114,115,116],"Kidney Failure","Liver Failure, Chronic","Kidney-Pancreas Failure","2025-09-03",{"date":119,"type":120},"2025-09-10","ACTUAL",{"date":122,"type":120},"2019-05-23",{"date":124,"type":108},"2028-09-30",{"name":5,"class":6},4]