Kidney Failure Clinical Trial
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)
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
Status | Recruiting |
Enrollment | 362 |
Est. completion date | September 30, 2025 |
Est. primary completion date | September 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University Graz | Graz | |
Austria | Medical University Innsbruck | Innsbruck | |
Austria | Ordensklinikum Linz | Linz | |
Austria | Medical University Vienna | Wien |
Lead Sponsor | Collaborator |
---|---|
Dr. F. Köhler Chemie GmbH |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Kidney: - delayed graft function: Dialysis requirement during the first week af-ter transplantation | 7 days | ||
Primary | Liver: - area under the curve (AUC) GPT (ALT) after transplantation during 7 days (minimum 1 measurement per day) | 7 days |
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