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Calcineurin Inhibitor in NEuRoloGically Deceased Donors to Decrease Kidney delaYed Graft Function (CINERGY)
Sponsor: Université de Sherbrooke
Summary
The 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.
Official title: Calcineurin Inhibitor in NEuRoloGically Deceased Donors to Decrease Kidney delaYed Graft Function (CINERGY)-Pilot Trial
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
414
Start Date
2022-07-11
Completion Date
2026-01
Last Updated
2025-04-17
Healthy Volunteers
No
Interventions
Tacrolimus
Single dose intravenous tacrolimus over 4 hour infusion at a dose of 0.02 mg/kg ideal body weight diluted with 0.9% sodium chloride starting 4-8 hours before scheduled organ recovery.
Placebo
Single dose of intravenous 0.9% sodium chloride over 4 hour infusion, starting 4-8 hours before scheduled organ recovery.
Locations (9)
Vancouver General Hospital
Vancouver, British Columbia, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
L'Institut de Cardiologie de Montréal
Montreal, Quebec, Canada
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Montréal
Montreal, Quebec, Canada
Centre universitaire de santé McGill (CUSM)
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Québec- Université Laval
Québec, Quebec, Canada
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
Québec, Quebec, Canada
Centre de recherche CHUS
Sherbrooke, Quebec, Canada