New fluid could keep transplant organs healthier longer

NCT ID NCT03627013

Disease control Sponsor: Dr. F. Köhler Chemie GmbH Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 3 trial tests a new solution called Custodiol-N for preserving donated kidneys, livers, and pancreases before transplant. About 362 recipients will be randomly assigned to receive organs stored in either Custodiol-N or the standard Custodiol solution. The goal is to see if Custodiol-N works as well or better at preventing early organ damage and reducing the need for dialysis after kidney transplant.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Custodiol-N solution (organ preservation fluid)
What this could lead to: If it works, this could lead to better preservation of donated organs, reducing the need for dialysis after kidney transplant and improving liver function after transplant.
What could go wrong: This is a non-inferiority trial, meaning it only aims to show Custodiol-N is as good as the current solution, not necessarily better. Results may not apply to all transplant centers or organ types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 362 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2019

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

chronic liver failure End Stage Liver Disease kidney failure multiple organ dysfunction syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Kidney failure Kidney-pancreas failure Liver failure, chronic

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

4 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

New fluid could keep transplant organs healthier longer

What the study statuses mean