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

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. F. Köhler Chemie GmbH
• Treatments: Pancreatin; Pancrelipase; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• All organs (kidney, combined kidney - pancreas and liver) Donor criteria

• deceased adult (≥18 years) 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

• donors whose organs are all allocated out of Austria

• 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 excluded

Liver recipient

• retransplantation

• machine perfusion