Clinical Trial

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

Study acronym: CINERGY
Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Record status
This record was last updated April 17, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2021-12-07; most recent amendment 2025-04-11.
Status change: Recruiting → Active, Not Recruiting 2025-04-11
Status change: Not Yet Recruiting → Recruiting 2023-04-17
Trial Details
NCT Number NCT05148715
Lead Sponsor Université de Sherbrooke
Collaborators: McMaster University
Conditions Organ Transplant Failure or Rejection, Brain Death, Ischemic Reperfusion Injury
Enrollment 414 participants
Start Date 2022-07-11
Primary Completion 2025-12 (estimated)
Study Completion 2026-01 (estimated)
Updated on ClinicalTrials.gov 2025-04-17