Custodiol-N Solution Compared With Custodiol Solution in Organ Transplantation (Kidney, Liver and Pancreas)
Recruiting
Phase 3
Interventional Study
Kidney Failure
Liver Failure, Chronic
Kidney-Pancreas Failure
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 362 (estimated)
- Sponsor
- Dr. F. Köhler Chemie GmbH · Industry
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About This Trial
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 inten…
Trial Locations
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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) …
Contacts