Custodiol-N Solution Compared With Custodiol Solution in Organ Transplantation (Kidney, Liver and Pancreas)
Recruiting · NCT03627013 · Interventional (participants receive a specific treatment) · Lead sponsor: Dr. F. Köhler Chemie GmbH
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
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
Where it is running
4 locations listed.
- Medical University Graz - Graz, Austria
- Medical University Innsbruck - Innsbruck, Austria
- Ordensklinikum Linz - Linz, Austria
- Medical University Vienna - Vienna, Austria