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

  • STATUS
    Recruiting
  • End date
    May 1, 2023
  • participants needed
    614
  • sponsor
    Dr. F. Köhler Chemie GmbH
Updated on 23 January 2021
organ transplantation
kidney transplant

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=614 including:

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

Liver 202

Details
Condition Renal Failure, Nephropathy, End Stage Liver Disease, Kidney Disease (Pediatric), Kidney Failure (Pediatric), Kidney Disease, Kidney Failure, Kidney-Pancreas Failure, Kidney-Pancreas Failure, renal insufficiency, Kidney-Pancreas Failure
Treatment Custodiol-N Solution, Custodiol HTK Solution
Clinical Study IdentifierNCT03627013
SponsorDr. F. Köhler Chemie GmbH
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

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 Austria
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
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