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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
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
For All patients undergoing deceased donation:
For All patients undergoing living kidney donation:
Patient (recipient) criteria
Exclusion criteria
Kidney / combined kidney -pancreas recipient
Liver recipient
Primary purpose
Allocation
Interventional model
Masking
362 participants in 6 patient groups
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Central trial contact
Astrid Friedel
Data sourced from clinicaltrials.gov
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