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

Study Overview
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Brief Summary
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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

Official Title
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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)

Conditions
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Kidney Failure, Liver Failure, Chronic, Kidney-Pancreas Failure

Intervention / Treatment
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* Drug: Custodiol-N Solution
* Drug: Custodiol HTK Solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kidney Custodiol-N<br> | Drug: Custodiol-N Solution<br>* Perfusion<br>|
| Active Comparator: Kidney Custodiol<br> | Drug: Custodiol HTK Solution<br>* Perfusion<br>|
| Experimental: Liver Custodiol-N<br> | Drug: Custodiol-N Solution<br>* Perfusion<br>|
| Active Comparator: Liver Custodiol<br> | Drug: Custodiol HTK Solution<br>* Perfusion<br>|
| Experimental: Kidney/Pancreas Custodiol-N<br> | Drug: Custodiol-N Solution<br>* Perfusion<br>|
| Active Comparator: Kidney/Pancreas Custodiol<br> | Drug: Custodiol HTK Solution<br>* Perfusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |