NCT03627013 Custodiol-N Solution Compared With Custodiol Solution in Organ Transplantation (Kidney, Liver and Pancreas)
| NCT ID | NCT03627013 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Dr. F. Köhler Chemie GmbH |
| Condition | Kidney Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 362 participants |
| Start Date | 2019-05-23 |
| Primary Completion | 2028-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 362 participants in total. It began in 2019-05-23 with a primary completion date of 2028-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03627013 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Kidney Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03627013 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 362 participants.
Is NCT03627013 currently recruiting?
Yes, NCT03627013 is actively recruiting participants. Contact the research team at astrid.friedel@medunigraz.at for enrollment information.
Where is the NCT03627013 trial being conducted?
This trial is being conducted at Graz, Austria, Innsbruck, Austria, Linz, Austria, Vienna, Austria.
Who is sponsoring the NCT03627013 clinical trial?
NCT03627013 is sponsored by Dr. F. Köhler Chemie GmbH. The trial plans to enroll 362 participants.
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