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

Kidney Failure Clinical Trial

Official 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03627013
• Other study ID #: CL-N-KLP-TX-III/07-AT/17
• Secondary ID: 2017-002198-20
• Status: Recruiting
• Phase: Phase 3
• Start date: May 23, 2019
• Est. completion date: September 30, 2025

Study information

• Verified date: May 2024
• Source: Dr. F. Köhler Chemie GmbH
• Contact: Astrid Friedel
• Phone: +4332638578017
• Email: astrid.friedel[@]medunigraz.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 362
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Liver Disease
• Kidney Failure
• Kidney-Pancreas Failure
• Liver Failure
• Liver Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• Custodiol-N Solution
Perfusion
• Custodiol HTK Solution
Perfusion

Locations

Country	Name	City	State
Austria	Medical University Graz	Graz
Austria	Medical University Innsbruck	Innsbruck
Austria	Ordensklinikum Linz	Linz
Austria	Medical University Vienna	Wien

Sponsors (1)

Lead Sponsor	Collaborator
Dr. F. Köhler Chemie GmbH

Country where clinical trial is conducted

Austria, 

Outcome

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