A Phase 3 interventional study of Custodiol-N Solution and Custodiol HTK Solution in Kidney Failure, Liver Failure, Chronic and Kidney-Pancreas Failure, sponsored by Dr. F. Köhler Chemie GmbH. Recruiting at 4 sites in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-10.
Sponsored by Dr. F. Köhler Chemie GmbH · Phase 3, Interventional, and Treatment
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
1,994 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's planned enrollment of 362 is above the median of 43 across 1,503 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →Dr. F. Köhler Chemie GmbH is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Kidney / combined kidney -pancreas recipient
Liver recipient
Drug: Custodiol-N Solution
Drug: Custodiol HTK Solution
Drug: Custodiol-N Solution
Drug: Custodiol HTK Solution
Drug: Custodiol-N Solution
Drug: Custodiol HTK Solution
Perfusion
Perfusion
Kidney: - delayed graft function: Dialysis requirement during the first week af-ter transplantation
Time frame: 7 days
Liver: - area under the curve (AUC) GPT (ALT) after transplantation during 7 days (minimum 1 measurement per day)
Time frame: 7 days
Plan to share: No
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Dr. F. Köhler Chemie GmbH