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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)
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
NIH
interventional
362
1 country
4
Study Start
May 23, 2019
Actual (reported)Primary Completion
September 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 8, 2018
Actual (reported)August 13, 2018
Actual (reported)May 23, 2019
Actual (reported)September 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Perfusion
Perfusion
Medical University Graz
Graz, Austria
Medical University Innsbruck
Innsbruck, Austria
Ordensklinikum Linz
Linz, Austria
First Submitted
August 8, 2018
First Posted
August 13, 2018
Study Start
May 23, 2019
Actual (reported)Primary Completion
September 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Medical University Vienna
Vienna, Austria
Study Completion
September 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 10, 2025
Record last verified: 2025-09
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Source: ClinicalTrials.gov.
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