Overview

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

Eligibility

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