Actively Recruiting
Custodiol-N Solution Compared With Custodiol Solution in Organ Transplantation (Kidney, Liver and Pancreas)
Led by Dr. F. Köhler Chemie GmbH · Updated on 2025-09-10
362
Participants Needed
4
Research Sites
488 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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-N compared to Custodiol with respect to both graft function and injury after transplantation of kidney, liver or combined kidney-pancreas. Patient 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. Planned number of patients (recipients) In total N=362 including: Kidney 242 (including approx. 30 combined kidney-pancreas) Liver 120
CONDITIONS
Official Title
Custodiol-N Solution Compared With Custodiol Solution in Organ Transplantation (Kidney, Liver and Pancreas)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Deceased adult donors (18 years or older) meeting organ donation criteria for kidney, combined kidney-pancreas, or liver
- Adult living kidney donors (18 years or older) meeting organ donation criteria
- Recipients waiting for kidney, combined kidney-pancreas, or liver transplant
- Recipients aged 18 years or older
- Recipients who have signed informed consent before transplantation
- Full organ transplantation for liver recipients
You will not qualify if you...
- Donors whose organs are allocated outside the retrieving study center (not for living kidney donors)
- General refusal of organ donation
- Donation after cardiac death (DCD)
- Pregnant or lactating patients
- Recipients participating in any other interventional study targeting preservation or ischemia/reperfusion injury
- Combined organ allocations other than kidney and pancreas
- Double kidney transplantation
- Pancreas retransplantation
- Use of machine perfusion
- Liver retransplantation
- Patients with PRA > 0% included only in living donation setting according to KDIGO guidelines
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Medical University Graz
Graz, Austria
Actively Recruiting
2
Medical University Innsbruck
Innsbruck, Austria
Actively Recruiting
3
Ordensklinikum Linz
Linz, Austria
Actively Recruiting
4
Medical University Vienna
Vienna, Austria
Actively Recruiting
Research Team
A
Astrid Friedel
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here