Clinical trial
Calcineurin Inhibitor in NEuRoloGically Deceased Donors to Decrease Kidney delaYed Graft Function (CINERGY)-Pilot Trial
Name
MP-31-2020-3348
Description
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 arms
Trial start
2022-07-11
Estimated PCD
2025-01-01
Trial end
2026-01-01
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
Tacrolimus
Other names:
Prograf
Placebo
Single dose of intravenous 0.9% sodium chloride over 4 hour infusion, starting 4-8 hours before scheduled organ recovery.
Arms:
Placebo
Size
414
Primary endpoint
Organ donor accrual rates
6 to 12 months after the beginning of the trial
Recipient consent rate
6 to 12 months after the beginning of the trial
Eligibility criteria
Neurologically deceased donors who meet the inclusion and exclusion criteria will be eligible for participating in this study along with the correlating organ recipients who meet inclusion criteria.
Donor Inclusion Criteria:
* ≥18 years of age;
* Neurologically deceased;
* Consent for deceased organ donation;
* All organ recipients have been identified;
* ≥ 1 kidney allocated to a recipient.
Donor Exclusion Criteria:
* Known hypersensitivity to tacrolimus or polyoxyl 60 hydrogenated castor oil;
* One or more organs allocated to a non-participating transplant program;
* Unlikely access to study drug (e.g., due to supply issues, or pharmacist availability);
* One or more organ recipients has not agreed to receive an organ from a donor participating in the study;
* One or more organs are allocated to a recipient under the age of 18;
* A transplant physician has judged that donor tacrolimus will be unsuitable for an intended recipient.
Recipient Inclusion Criteria
* Organ/Transplant graft originated from a donor enrolled in this study.
No exclusion criteria.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 414, 'type': 'ESTIMATED'}}
Updated at
2024-03-15
1 organization
1 drug
3 indications
Organization
Université de SherbrookeDrug
VarlilumabIndication
Organ Transplant Failure or RejectionIndication
Brain DeathIndication
Ischemic Reperfusion Injury