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

Study acronym: CINERGY
StatusActive, Not Recruiting
PhasePhase 2
Started
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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.

Record History

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  1. Primary completion date: Jan 2025 to Dec 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 7 to 9
    v5
  2. Primary completion date: Jan 2024 to Jan 2025
    • Study completion date: Jan 2025 to Jan 2026
    • Study title shortened, about 1 word
    v4
  3. Primary completion date: May 2023 to Jan 2024
    • Study completion date: Jun 2024 to Jan 2025
    • Study title expanded, about 11 words
    v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2022 to Jul 11, 2022
    • Study sites: 14 to 7
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05148715
Lead Sponsor Université de Sherbrooke
Collaborators: McMaster University
Conditions
(from sponsor)		 Organ Transplant Failure or Rejection, Brain Death, Ischemic Reperfusion Injury
Related terms Brain Death, Rejection, Psychology
Enrollment 414 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov