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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

414 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-11

Study Completion Date

2026-01-31

Brief Summary

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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.

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Detailed Description

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Background: Organ donation saves lives, and improves quality of life for thousands of people. But organ donation falls short of expectations for some patients who suffer early graft loss. During organ donation surgery, the supply of blood with oxygen and nutrients is suspended. When restored during transplant surgery, a cascade of inflammation perturbs the newly transplanted organ -causing ischemia-reperfusion injury. When severe, it can hinder transplant function in the early post-operative period, lead to profound critical illness, increase the risks of transplant rejection and chronic disease, and reduce the transplant lifespan. Administration of tacrolimus, a calcineurin inhibitor, to neurologically deceased donors may reduce ischemia-reperfusion injury in transplant recipients.

Objectives: The CINERGY Pilot Trial will test the feasibility of comparing tacrolimus to placebo for the prevention of delayed graft function in kidney recipients and establish the foundation for a large, multi-centre randomized controlled trial (RCT).

Methods: 90 neurologically deceased kidney donors will be randomized to either tacrolimus (0.02 mg/kg) or the corresponding placebo 4-8 hours before organ recovery. To be included in the CINERGY Pilot RCT, donors will need to meet inclusion criteria. All corresponding recipients are enrolled and their data is collected in the first 7 days and at 12 months after transplantation.

Outcomes: Feasibility: Donor accrual rate and consent rate of organ recipients. Safety: acute kidney injury, hyperkalemia and anaphylaxis in donors and recipients. Clinical: graft function within 7 days in all recipients, vital status, re-transplantation and need for dialysis at 12 months.

Relevance: This pilot study will inform the feasibility and design of a larger trial. Moreover, the CINERGY Pilot RCT will pave the way for future trials linking organ donation and transplantation across Canada.

Conditions

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Organ Transplant Failure or Rejection Brain Death Ischemic Reperfusion Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tacrolimus

Tacrolimus 0.02 mg/kg ideal body weight 4-8 hours before organ recovery

Group Type EXPERIMENTAL

Tacrolimus

Intervention Type DRUG

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.

Placebo

0.9% sodium chloride 4-8 hours before organ recovery

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single dose of intravenous 0.9% sodium chloride over 4 hour infusion, starting 4-8 hours before scheduled organ recovery.

Interventions

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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.

Intervention Type DRUG

Placebo

Single dose of intravenous 0.9% sodium chloride over 4 hour infusion, starting 4-8 hours before scheduled organ recovery.

Intervention Type DRUG

Other Intervention Names

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Prograf

Eligibility Criteria

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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.

* Organ/Transplant graft originated from a donor enrolled in this study.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years