Custodiol-N Solution Compared With Custodiol Solution in Organ Transplantation (Kidney, Liver and Pancreas)
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)
2 other identifiers
interventional
362
1 country
4
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2019
Longer than P75 for phase_3
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2018
CompletedFirst Posted
Study publicly available on registry
August 13, 2018
CompletedStudy Start
First participant enrolled
May 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2028
September 10, 2025
September 1, 2025
9.4 years
August 8, 2018
September 3, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (6)
Kidney Custodiol-N
EXPERIMENTALKidney Custodiol
ACTIVE COMPARATORLiver Custodiol-N
EXPERIMENTALLiver Custodiol
ACTIVE COMPARATORKidney/Pancreas Custodiol-N
EXPERIMENTALKidney/Pancreas Custodiol
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Medical University Graz
Graz, Austria
Medical University Innsbruck
Innsbruck, Austria
Ordensklinikum Linz
Linz, Austria
Medical University Vienna
Vienna, Austria
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2018
First Posted
August 13, 2018
Study Start
May 23, 2019
Primary Completion (Estimated)
September 30, 2028
Study Completion (Estimated)
September 30, 2028
Last Updated
September 10, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share