Trial | NCT03627013  Report issue

Title

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)

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    614
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=614 including:

Kidney 412 (including approx. 30 combined kidney-pancreas)

Liver 202
Study Started
May 23
2019
Primary Completion
Sep 30
2025
Anticipated
Study Completion
Sep 30
2025
Anticipated
Last Update
Oct 19
2023

Drug Custodiol-N Solution

Perfusion

Drug Custodiol HTK Solution

Perfusion

Kidney Custodiol-N Experimental

Kidney Custodiol Active Comparator

Liver Custodiol-N Experimental

Liver Custodiol Active Comparator

Kidney/Pancreas Custodiol-N Experimental

Kidney/Pancreas Custodiol Active Comparator

Criteria 

Inclusion Criteria:

All organs (kidney, combined kidney - pancreas and liver) Donor criteria
deceased adult (≥18 years) 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
- 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 excluded

Liver recipient

retransplantation
machine perfusion
No Results Posted