Kidney Failure, Kidney-Pancreas Failure, Liver Failure, Chronic
Conditions
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
Interventions
DRUGCustodiol-N Solution
Perfusion
DRUGCustodiol HTK Solution
Perfusion
Sponsors
Dr. F. Köhler Chemie GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Countries
Austria
Contacts
Primary ContactAstrid Friedel
Outcome results
None listed