A Phase 2 interventional study of Tacrolimus and Placebo in Organ Transplant Failure or Rejection, Brain Death and Ischemic Reperfusion Injury, sponsored by Université de Sherbrooke. Active, not recruiting at 9 sites in Canada. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-04-17.
Sponsored by Université de Sherbrooke · Phase 2, Interventional, and Treatment
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.
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.
74 studies on the registry are indexed under Brain Death; 10 are open to participants now.
This study's planned enrollment of 414 is above the median of 154 across 39 interventional studies indexed under Brain Death.
Browse Brain Death studies →Université de Sherbrooke is the lead sponsor of 295 studies on the registry; 65 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Donor Exclusion Criteria:
Recipient Inclusion Criteria
No exclusion criteria.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tacrolimus 0.02 mg/kg ideal body weight 4-8 hours before organ recovery
Drug: Tacrolimus
0.9% sodium chloride 4-8 hours before organ recovery
Drug: Placebo
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.
Also known as: Prograf
Single dose of intravenous 0.9% sodium chloride over 4 hour infusion, starting 4-8 hours before scheduled organ recovery.
Organ donor accrual rates
One primary objective of this pilot study is to determine if a national multi-centre placebo randomized controlled trial (RCT) will be feasible with respect to: organ donor accrual.
Time frame: 6 to 12 months after the beginning of the trial
Recipient consent rate
Another primary objective of this pilot study is to determine if a national multi-centre placebo controlled RCT will be feasible with respect to the consent rates of organ recipients. Recipient consent rates will be assessed during analysis, analyzing the rate and reasons for non-enrolment.
Time frame: 6 to 12 months after the beginning of the trial
Correlation between two methods for obtaining survival status
We will compare 2 methods (Hospital records, Canadian Institute for Health Information) for obtaining recipient survival at 12 months post-transplant.
Time frame: 12 months post transplant
Unexpected adverse events
In donors and recipients, unexpected adverse events as identified by clinical staff will be reported and analyzed.
Time frame: Within 7 days post transplant
Percentage of donors with acute kidney injury (AKI)
AKI defined as defined as Kidney disease: Improving global outcome (KDIGO) stage II (or more): serum creatinine ≥ 2.0 times baseline OR a urine output \<0.5mL/kg/h for ≥12 hours
Time frame: Within 4 hours after the end of the study drug infusion
Percentage of donors with hyperkalemia
Hyperkalemia defined as a potassium level \> 5 mmol/L
Time frame: Within 4 hours after the end of the study drug infusion
Percentage of donors hypertension during tacrolimus infusion
Hypertension (systolic blood pressure ≥ 160 mmHg or mean arterial pressure ≥ 90 mmHg for \> 15 minutes)
Time frame: Within 4 hours after the initiation of study drug infusion
Percentage of donors with cardiac arrhythmia associated with tacrolimus infusion
Cardiac arrhythmias defined as new onset of atrial fibrillation or flutter, ventricular tachycardia or fibrillation
Time frame: Within 4 hours after the initiation of study drug infusion
Percentage of donors with anaphylaxis
Anaphylaxis defined as per The American Academy of Allergy, Asthma and Immunology
Time frame: Within 4 hours after the initiation of study drug infusion
Percentage of recipients with acute kidney injury
AKI defined as defined as KDIGO stage II or more: serum creatinine ≥ 2.0 times baseline OR a urine output \<0.5mL/kg/h for ≥12 hours
Time frame: Within 7 days post transplant
Percentage of recipients with hyperkalemia
Hyperkalemia defined as a potassium level \> 5 mmol/L
Time frame: Within 7 days post transplant
Percentage of recipients with anaphylaxis
Anaphylaxis defined as per The American Academy of Allergy, Asthma and Immunology
Time frame: Within 7 days post transplant
Recipient serum tacrolimus levels
Clinical research staff will abstract routine serum tacrolimus levels (when measured) from hospital records over the first 7 days, along with local thresholds for toxic level.
Time frame: Within 7 days post transplant
Percentage of liver recipients with early graft function
At least ≥ 1 of the following criteria: Bilirubin ≥ 10 mg/dL , International normalized ratio (INR) ≥ 1.6 AST or ALT level \> 2000 IU/
Time frame: Within 7 days post transplant
Graft survival
Need to be re-transplanted or to be on the re-transplant list.
Time frame: 12 months post transplant
Recipient survival
Recipient death
Time frame: 12 months post transplant
Recipients requiring dialysis
Recipient requirement for dialysis at 12 months
Time frame: 12 months post transplant
Percentage of lungs recipients with severe primary graft dysfunction
PaO2/FiO2 ratio \<200 and diffuse infiltration/pulmonary edema on chest radiograph
Time frame: Within 3 days post transplant
Percentage of kidney recipients with delayed graft function
Requirement of ≥ 1 hemodialysis session
Time frame: Within 7 days post transplant
Percentage of heart recipients with severe primary graft dysfunction
Dependence on mechanical support
Time frame: Within 1 days post transplant
Percentage of pancreas recipients with delayed graft function
Requirement of ≥1 exogenous insulin at hospital discharge
Time frame: At hospital discharge, an average of 7 days
This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tacrolimus