Clinical trial NCT03627013: Custodiol-N Solution Compared With Custodiol Solution in Organ Transplantation (Kidney, Liver and Pancreas)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Kidney Failure
Liver Failure, Chronic
Kidney-Pancreas Failure
Lead sponsor: Dr. F. Köhler Chemie GmbH
Sponsor class: INDUSTRY
First posted: 2018-08-13
Enrollment: 362
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Kidney: - delayed graft function: Dialysis requirement during the first week af-ter transplantation
timeFrame: 7 days
measure: Liver: - area under the curve (AUC) GPT (ALT) after transplantation during 7 days (minimum 1 measurement per day)
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
city: Linz
country: Austria
facility: Ordensklinikum Linz
city: Wien
country: Austria
facility: Medical University Vienna
Study officials:
References: