{"id":"htk-custodiol","safety":{"commonSideEffects":[{"rate":null,"effect":"Graft dysfunction"},{"rate":null,"effect":"Delayed graft function"},{"rate":null,"effect":"Ischemic reperfusion injury"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Custodiol is a histidine-tryptophan-ketoglutarate (HTK) based solution designed to preserve organs during transplantation. It maintains intracellular electrolyte composition, provides metabolic substrates, and includes antioxidants and buffers to reduce ischemic reperfusion injury during the cold ischemia period before organ implantation.","oneSentence":"HTK Custodiol is an organ preservation solution that maintains cellular viability during cold storage by providing essential electrolytes, buffers, and substrates while minimizing ischemic injury.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:23:13.643Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Cold preservation of donor organs for transplantation (heart, kidney, liver, pancreas)"},{"name":"Organ preservation during transport and storage prior to transplantation"}]},"trialDetails":[{"nctId":"NCT07205757","phase":"PHASE4","title":"Adding Lidocaine to Custodiol Mixture","status":"RECRUITING","sponsor":"Fayoum University Hospital","startDate":"2025-10-03","conditions":"CAD, Arrhythmia Ventricular","enrollment":70},{"nctId":"NCT03627013","phase":"PHASE3","title":"Custodiol-N Solution Compared With Custodiol Solution in Organ Transplantation (Kidney, Liver and Pancreas)","status":"RECRUITING","sponsor":"Dr. F. Köhler Chemie GmbH","startDate":"2019-05-23","conditions":"Kidney Failure, Liver Failure, Chronic, Kidney-Pancreas Failure","enrollment":362},{"nctId":"NCT06530641","phase":"PHASE4","title":"Evaluation of Clinical Impact of the Type of Cardioplegia Used in the Patient Undergoing Major Cardiac Surgery.","status":"RECRUITING","sponsor":"Lourdes Montero Cruces","startDate":"2024-12-01","conditions":"Cardiac Surgery, Cardioplegia, Heart Arrest","enrollment":600},{"nctId":"NCT03082716","phase":"PHASE2","title":"Custodiol Versus Blood Cardioplegaia in Paediatric Cardiac Surgery","status":"COMPLETED","sponsor":"King Faisal Specialist Hospital & Research Center","startDate":"2016-03-16","conditions":"Congenital Heart Disease","enrollment":49},{"nctId":"NCT05031052","phase":"NA","title":"Normothermic Machine Perfusion (NMP) Versus Static Cold Storage (SCS) in Human Kidney Transplantation","status":"UNKNOWN","sponsor":"Charite University, Berlin, Germany","startDate":"2022-05-10","conditions":"Kidney Transplant; Complications, Kidney Failure, Graft Dysfunction","enrollment":194},{"nctId":"NCT01681095","phase":"PHASE2","title":"Custodiol-HTK (Histidine-tryptophan-ketoglutarate) Solution as a Cardioplegic Agent","status":"COMPLETED","sponsor":"Marc Sakwa, MD","startDate":"2012-08","conditions":"Coronary Artery Disease, Myocardial Ischemia, Coronary Disease","enrollment":110},{"nctId":"NCT01564095","phase":"PHASE2, PHASE3","title":"TOP-Study (Tacrolimus Organ Perfusion): Treatment of Ischemia Reperfusion Injury in Marginal Organs With an ex Vivo Tacrolimus Perfusion","status":"TERMINATED","sponsor":"Ludwig-Maximilians - University of Munich","startDate":"2011-10","conditions":"Terminal Liver Disease, Ischemia Reperfusion Injury, Graft Dysfunction","enrollment":25},{"nctId":"NCT01887171","phase":"NA","title":"Evaluation of Preimplantation Portal Vein and Hepatic Artery Flushing With Tacrolimus","status":"COMPLETED","sponsor":"Republican Scientific and Practical Center for Organ and Tissue Transplantation","startDate":"2013-07","conditions":"Early Allograft Dysfunction, Ischemic Reperfusion Injury, Liver Transplantation","enrollment":86},{"nctId":"NCT01614951","phase":"PHASE4","title":"The Pulmonary Protection Trial","status":"COMPLETED","sponsor":"Rigshospitalet, Denmark","startDate":"2012-07","conditions":"Chronic Obstructive Lung Disease","enrollment":90}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":26,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"HTK Custodiol","genericName":"HTK Custodiol","companyName":"Rigshospitalet, Denmark","companyId":"rigshospitalet-denmark","modality":"Small molecule","firstApprovalDate":"","aiSummary":"HTK Custodiol is an organ preservation solution that maintains cellular viability during cold storage by providing essential electrolytes, buffers, and substrates while minimizing ischemic injury. Used for Cold preservation of donor organs for transplantation (heart, kidney, liver, pancreas), Organ preservation during transport and storage prior to transplantation.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}