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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: astrid.friedel@medunigraz.at
• Phone: +4332638578017

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.