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

NCT05148715 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: MP-31-2020-3348
• Study Type: interventional
• Target: 414
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Organ Transplant Failure or Rejection; Brain Death; Ischemic Reperfusion Injury

Keywords

organ donation and transplantation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 to 12 months after the beginning of the trial

Secondary Outcomes (19)

• Correlation between two methods for obtaining survival status

  12 months post transplant

• Unexpected adverse events

  Within 7 days post transplant

• Percentage of donors with acute kidney injury (AKI)

  Within 4 hours after the end of the study drug infusion

• Percentage of donors with hyperkalemia

  Within 4 hours after the end of the study drug infusion

• Percentage of donors hypertension during tacrolimus infusion

  Within 4 hours after the initiation of study drug infusion

Study Arms (2)

Tacrolimus

EXPERIMENTAL

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

Drug: Tacrolimus

Placebo

PLACEBO COMPARATOR

0.9% sodium chloride 4-8 hours before organ recovery

Drug: Placebo

Interventions

Tacrolimus 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.

Also known as: Prograf

Tacrolimus

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• ≥18 years of age;
• Neurologically deceased;
• Consent for deceased organ donation;
• All organ recipients have been identified;
• ≥ 1 kidney allocated to a recipient.
• 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.
• Organ/Transplant graft originated from a donor enrolled in this study.

Sponsors & Collaborators

• Université de Sherbrooke: lead
• McMaster University: collaborator

Study Sites (9)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

L'Institut de Cardiologie de Montréal

Montreal, Quebec, H1T 1C8, Canada

Location

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

Centre Hospitalier Universitaire de Montréal

Montreal, Quebec, H2X 3E4, Canada

Location

Centre universitaire de santé McGill (CUSM)

Montreal, Quebec, H4A 3J1, Canada

Location

Centre Hospitalier Universitaire de Québec- Université Laval

Québec, Quebec, G1V 4G2, Canada

Location

Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)

Québec, Quebec, G1V 4G5, Canada

Location

Centre de recherche CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (1)

• D'Aragon F, Selzner M, Breau R, Masse MH, Lamontagne F, Masse M, Chasse M, Carrier FM, Cardinal H, Chaudhury P, Weiss M, Lauzier F, Turgeon AF, Frenette AJ, Bolduc B, Ducharme A, Lamarche C, Couture E, Holdsworth S, Bertholz L, Talbot H, Slessarev M, Luke P, Boyd JG, Shamseddin MK, Burns KEA, Zaltzman J, English S, Knoll G, Dhanani S, Healey A, Hanna S, Rochwerg B, Oczkowski SJW, Treleaven D, Meade M; Canadian Critical Care Trials Group and the Canadian Donation and Transplant Research Program. Calcineurin Inhibitor in NEuRoloGically deceased donors to decrease kidney delayed graft function study: study protocol of the CINERGY Pilot randomised controlled trial. BMJ Open. 2024 Jun 13;14(6):e086777. doi: 10.1136/bmjopen-2024-086777.

  PMID: 38871657 DERIVED

MeSH Terms

Conditions

Rejection, Psychology; Brain Death

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Coma; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Frédérick D'Aragon

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

• Maureen Meade

  McMaster University

  PRINCIPAL INVESTIGATOR

• Markus Selzner

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: December 8, 2021
• Study Start: July 11, 2022
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: April 17, 2025

Record last verified: 2025-04

Locations

CA (9)