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ACTIVE NOT RECRUITING
NCT05148715
PHASE2

Calcineurin Inhibitor in NEuRoloGically Deceased Donors to Decrease Kidney delaYed Graft Function (CINERGY)

Sponsor: Université de Sherbrooke

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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