Custodiol-N Solution Compared With Custodiol Solution in Organ Transplantation (Kidney, Liver and Pancreas)
Status:
Recruiting
Trial end date:
2023-05-01
Target enrollment:
Participant gender:
Summary
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=614 including:
Kidney 412 (including approx. 30 combined kidney-pancreas)
Liver 202