🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Custodiol-N Solution Compared With Custodiol Solution in Organ Transplantation (Kidney, Liver and Pancreas)

RecruitingPhase 3Ages 18 Years - anyAllDr. F. Köhler Chemie GmbH
NCT03627013 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

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) Protocol number: CL-N-KLP-TX-III/07-AT/17 Trial 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. Intended 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). Purpose of the study The objective of this investigation is to demonstrate non-inferiority of graft preservation with Custodiol-

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
Inclusion Criteria: * All organs (kidney, combined kidney - pancreas and liver) Donor criteria For All patients undergoing deceased donation: \- deceased adult (≥18 years) donors fulfilling the criteria for organ donation For All patients undergoing living kidney donation: \- adult (≥18 years) living kidney donors fulfilling the criteria for organ donation Patient (recipient) criteria * recipients awaiting their transplant * recipients ≥18 years * recipients' signed informed consent before the transplantation Kidney / combined kidney - pancreas recipients * n/a Liver recipient * full organ transplantation Exclusion Criteria: * All organs (kidney, combined kidney - pancreas and liver) Donor criteria (not applicable for living kidney donors) * \- donors whose organs are all allocated out of retrieving study center * general refusal of organ donation * donation after cardiac death (DCD) Patient (recipient) criteria * pregnant or lactating patients * recipients participating in any interventional study (e.g. another study involving compound/interventions aimed at the reduction of preservation and / or ischemia / reperfusion injury) * all combined allocations other than pancreas and kidney Kidney / combined kidney -pancreas recipient * double kidney transplantation * pancreas retransplantation * machine perfusion According to the KDIGO-Guidelines (2009) all patients with PRA \>0% are only included in the living donation setting. Liver recipient * retransplantation * machine perfusion
💊

What it tests

  • Custodiol-N Solution
  • Custodiol HTK Solution
📍

Where

4 sites
Medical University Graz
Graz, Austria
Medical University Innsbruck
Innsbruck, Austria
Ordensklinikum Linz
Linz, Austria
Medical University Vienna
Vienna, Austria
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy