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

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)

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

Study Overview

• Status: Recruiting
• Conditions: Kidney Failure; Liver Failure, Chronic; Kidney-Pancreas Failure
• Intervention / Treatment: Drug: Custodiol-N Solution; Drug: Custodiol HTK Solution

• Study Type: Interventional
• Enrollment (Estimated): 362
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Astrid Friedel; Phone Number: +4332638578017; Email: astrid.friedel@medunigraz.at

Study Locations

• Austria
  • Graz, Austria
    • Recruiting
    • Medical University Graz
    • Contact: Stiegler
  • Innsbruck, Austria
    • Recruiting
    • Medical University Innsbruck
    • Contact: Schneeberger
  • Linz, Austria
    • Recruiting
    • Ordensklinikum Linz
    • Contact: Biebl
  • Vienna, Austria
    • Recruiting
    • Medical University Vienna
    • Contact: Berlakovich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kidney Custodiol-N	Drug: Custodiol-N Solution; Perfusion
Active Comparator: Kidney Custodiol	Drug: Custodiol HTK Solution; Perfusion
Experimental: Liver Custodiol-N	Drug: Custodiol-N Solution; Perfusion
Active Comparator: Liver Custodiol	Drug: Custodiol HTK Solution; Perfusion
Experimental: Kidney/Pancreas Custodiol-N	Drug: Custodiol-N Solution; Perfusion
Active Comparator: Kidney/Pancreas Custodiol	Drug: Custodiol HTK Solution; Perfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Kidney: - delayed graft function: Dialysis requirement during the first week af-ter transplantation	7 days
Liver: - area under the curve (AUC) GPT (ALT) after transplantation during 7 days (minimum 1 measurement per day)	7 days

Collaborators and Investigators

• Sponsor: Dr. F. Köhler Chemie GmbH

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2019
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: August 8, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (Actual): August 13, 2018

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 3, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Digestive System Diseases; Liver Diseases; Liver Failure; Hepatic Insufficiency; Renal Insufficiency; End Stage Liver Disease; Custodiol-N solution; Bretschneider cardioplegic solution
• Other Study ID Numbers: CL-N-KLP-TX-III/07-AT/17; 2017-002198-20 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No