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NCT Number: NCT03627013

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

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

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Key information

Conditions

Kidney Failure Digestive System Diseases End Stage Liver Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hepatic Insufficiency Kidney Diseases Kidney-Pancreas Failure Liver Diseases Liver Failure Liver Failure, Chronic Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical University Graz, Graz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Custodiol-N Solution

Drug

Perfusion

Custodiol HTK Solution

Drug

Perfusion

Primary outcomes

  1. Kidney: - delayed graft function: Dialysis requirement during the first week af-ter transplantation

    Time frame: 7 days

  2. Liver: - area under the curve (AUC) GPT (ALT) after transplantation during 7 days (minimum 1 measurement per day)

    Time frame: 7 days

Study contacts

Contact information is provided by the study sponsor or research team.

Astrid Friedel

CONTACT

[email protected]

+4332638578017

Sponsors and collaborators

Lead sponsor

Dr. F. Köhler Chemie GmbH

Industry

Registry information

Official study title

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)

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Aug 13, 2018
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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