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

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