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

Last updated: September 3, 2025
Sponsor: Dr. F. Köhler Chemie GmbH
Overall Status: Active - Recruiting

Phase

3

Condition

Kidney Failure (Pediatric)

Liver Failure

Nephropathy

Treatment

Custodiol HTK Solution

Custodiol-N Solution

Clinical Study ID

NCT03627013
CL-N-KLP-TX-III/07-AT/17
2017-002198-20
  • Ages > 18
  • All Genders

Study 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=362 including:

Kidney 242 (including approx. 30 combined kidney-pancreas)

Liver 120

Eligibility Criteria

Inclusion

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 / combinedkidney - pancreas recipients

  • n/a Liver recipient

  • full organ transplantation

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 362
Treatment Group(s): 2
Primary Treatment: Custodiol HTK Solution
Phase: 3
Study Start date:
May 23, 2019
Estimated Completion Date:
September 30, 2028

Connect with a study center

  • Medical University Graz

    Graz,
    Austria

    Site Not Available

  • Medical University Graz

    Graz 2778067,
    Austria

    Active - Recruiting

  • Medical University Innsbruck

    Innsbruck,
    Austria

    Site Not Available

  • Medical University Innsbruck

    Innsbruck 2775220,
    Austria

    Active - Recruiting

  • Ordensklinikum Linz

    Linz,
    Austria

    Site Not Available

  • Ordensklinikum Linz

    Linz 2772400,
    Austria

    Active - Recruiting

  • Medical University Vienna

    Vienna 2761369,
    Austria

    Active - Recruiting

  • Medical University Vienna

    Wien,
    Austria

    Site Not Available

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