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

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.

Timeline

Start

2022-07-11

Primary completion

2025-12

Completion

2026-01

Publications

• D'Aragon F, Selzner M, Breau R, Masse MH, Lamontagne F, Masse M, Chasse M, Carrier FM, Cardinal H, Chaudhury P, Weiss M, Lauzier F, Turgeon AF, Frenette AJ, Bolduc B, Ducharme A, Lamarche C, Couture E, Holdsworth S, Bertholz L, Talbot H, Slessarev M, Luke P, Boyd JG, Shamseddin MK, Burns KEA, Zaltzman J, English S, Knoll G, Dhanani S, Healey A, Hanna S, Rochwerg B, Oczkowski SJW, Treleaven D, Meade M; Canadian Critical Care Trials Group and the Canadian Donation and Transplant Research Program. Calcineurin Inhibitor in NEuRoloGically deceased donors to decrease kidney delayed graft function study: study protocol of the CINERGY Pilot randomised controlled trial. BMJ Open. 2024 Jun 13;14(6):e086777. doi: 10.1136/bmjopen-2024-086777.

Drugs

Indications