Comparison of Custodiol-N and Custodiol solutions for organ preservation in transplantation

A Prospective, Randomized, Single Blind, Multicentre Phase III Study on Organ Preservation With Custodiol-N Solution Compared With Custodiol Solution in Or-gan Transplantation (Kidney, Liver and Pancreas)

This study is testing if a new organ preservation solution called Custodiol-N works just as well as the standard Custodiol solution for keeping kidneys, livers, and pancreas healthy for transplant.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 362 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Dr. F. Köhler Chemie GmbH (industry)
• Locations: 4 sites (Graz and 3 other locations)
• Trial ID: NCT03627013 on ClinicalTrials.gov

What this trial studies

This phase III clinical trial is a prospective, randomized, single-blind, multicenter study aimed at comparing the effectiveness of Custodiol-N solution against Custodiol solution in preserving organs for transplantation, specifically kidneys, livers, and pancreas. The study will assess the non-inferiority of Custodiol-N in terms of graft function and injury post-transplantation. Participants will include both deceased and living organ donors, as well as recipients awaiting transplantation. The trial is expected to last approximately 30 months, with each participant undergoing a follow-up period of 90 days after transplantation.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are recipients awaiting kidney, liver, or combined kidney-pancreas transplants.

Not a fit: Patients who are pregnant, lactating, or those whose organs are allocated outside the retrieving study center may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve organ preservation techniques, leading to better transplant outcomes for patients.

How similar studies have performed: Previous studies have shown promising results with similar organ preservation solutions, indicating potential for success in this approach.

Eligibility criteria

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

Where this trial is running

Graz and 3 other locations

• Medical University Graz — Graz, Austria (RECRUITING)
• Medical University Innsbruck — Innsbruck, Austria (RECRUITING)
• Ordensklinikum Linz — Linz, Austria (RECRUITING)
• Medical University Vienna — Vienna, Austria (RECRUITING)

Study contacts

• Study coordinator: Astrid Friedel

Conditions: Kidney Failure, Liver Failure, Chronic, Kidney-Pancreas Failure