Custodiol-N Solution Compared With Custodiol Solution in Organ Transplantation (Kidney, Liver and Pancreas)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Custodiol-N Solution, Custodiol HTK Solution.
- Who it may be relevant to
- Registry conditions: Kidney Failure, Liver Failure, Chronic, Kidney-Pancreas Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
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
Interventions
- Drug Custodiol-N Solution
Perfusion - Drug Custodiol HTK Solution
Perfusion
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Austria · 4 centers
- Medical University Graz — Graz
- Medical University Innsbruck — Innsbruck
- Ordensklinikum Linz — Linz
- Medical University Vienna — Vienna
Identifiers
NCT: NCT03627013 · CL-N-KLP-TX-III/07-AT/17 · 2017-002198-20