Calcineurin Inhibitor in NEuRoloGically Deceased Donors to Decrease Kidney delaYed Graft Function (CINERGY)
Brain Death | Ischemic Reperfusion Injury | Organ Transplant Failure or RejectionThe investigators hypothesize that preconditioning neurologically deceased organ donors with the calcineurin inhibitor tacrolimus will improve short and long-term transplant survival without causing harm. Organ donors will be randomized to receive either 0.02 mg/kg ideal body weight (IBW) of tacrolimus single infusion or placebo before organ recovery. All corresponding recipients are enrolled and data is collected up to 7 days post-transplant to determine graft function and at 1 year to collect outcomes of vital status, re-transplantation and dialysis. The CINERGY Pilot Trial assesses feasibility for the main trial.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation Criteria
Neurologically deceased donors who meet the inclusion and exclusion criteria will be eligible for participating in this study along with the correlating organ recipients who meet inclusion criteria.
Donor Inclusion Criteria:
* ≥18 years of age;
* Neurologically deceased;
* Consent for deceased organ donation;
* All organ recipients have been identified;
* ≥ 1 kidney allocated to a recipient.
Donor Exclusion Criteria:
* Known hypersensitivity to tacrolimus or polyoxyl 60 hydrogenated castor oil;
* One or more organs allocated to a non-participating transplant program;
* Unlikely access to study drug (e.g., due to supply issues, or pharmacist availability);
* One or more organ recipients has not agreed to receive an organ from a donor participating in the study;
* One or more organs are allocated to a recipient under the age of 18;
* A transplant physician has judged that donor tacrolimus will be unsuitable for an intended recipient.
Recipient Inclusion Criteria
* Organ/Transplant graft originated from a donor enrolled in this study.
No exclusion criteria.
Study Location
Centre universitaire de santé McGill (CUSM)
Centre universitaire de santé McGill (CUSM)Montréal, Quebec
Canada
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Centre Hospitalier Universitaire de Montréal
Centre Hospitalier Universitaire de MontréalMontréal, Quebec
Canada
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Centre de recherche CHUS
Centre de recherche CHUSSherbrooke, Quebec
Canada
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Centre Hospitalier Universitaire de Québec- Université Laval
Centre Hospitalier Universitaire de Québec- Université LavalQuebec city, Quebec
Canada
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L'Institut de Cardiologie de Montréal
L'Institut de Cardiologie de MontréalMontréal, Quebec
Canada
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Hôpital Maisonneuve-Rosemont
Hôpital Maisonneuve-RosemontMontréal, Quebec
Canada
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Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)Québec City, Quebec
Canada
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- Study Sponsored By
- Université de Sherbrooke
- Participants Required
- More Information
- Study ID:
NCT05148715