Calcineurin Inhibitor in NEuRoloGically Deceased Donors to Decrease Kidney

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05148715
Study type	Interventional
Source	Université de Sherbrooke
Contact	Ruth Breau
Phone	9055259140
Email	breaur@mcmaster.ca
Status	Recruiting
Phase	Phase 2
Start date	July 11, 2022
Completion date	January 2026

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03765814` - The Anticipated Organ Donation Approach
Completed	`NCT02581111` - Naloxone for Optimizing Hypoxemia Of Lung Donors	Phase 2/Phase 3
Completed	`NCT00808691` - Microcirculation and Oxidative Stress in Critical Ill Patients in Surgical Intensive Care Unit	N/A
Completed	`NCT00998972` - N-acetyl-cysteine (NAC) and Kidney Graft Function	Phase 3
Completed	`NCT04528797` - Thyroid and Adrenocortical Hormone Replacement in Organ Donors	N/A
Completed	`NCT03672812` - The Use of Liraglutide in Brain Death	Phase 3
Completed	`NCT04303624` - Understanding Family Refusal
Completed	`NCT03098706` - Therapeutic Hypothermia in "Expanded Criteria" Brain-dead Donors and Kidney-graft Function	N/A
Not yet recruiting	`NCT04623294` - Online Noninvasive Assessment of Human Brain Death and Deep Coma by Near-infrared Spectroscopy
Recruiting	`NCT02102945` - Special Imaging Technique to Aid in the Diagnosis of Patients in Coma After Cardiac Arrest	N/A
Completed	`NCT02483273` - Alterations of Conjunctival Microcirculation in Brain Dead Patients	N/A
Terminated	`NCT00675272` - Organ Donation and Hydrocortisone Treatment	N/A
Completed	`NCT03262896` - Neurophysiological Examination in Patients With Brain Death
Not yet recruiting	`NCT06359119` - Implementation of Apnoea Test for Patients With Suspected Brain Death
Recruiting	`NCT05202886` - "LiverColor": Machine Learning in Liver Photographs	N/A
Completed	`NCT03281993` - Apnea Tests as the Methods of Brain Death Diagnosis.	N/A
Completed	`NCT03179020` - Donation Network to Optimize Organ Recovery Study	N/A
Completed	`NCT05070182` - Resting Energy Needs in Brain Dead Patients (reSting EneRgy nEeds iN brAin DEad Patients)
Terminated	`NCT03439995` - Goal of Open Lung Ventilation in Donors	N/A
Completed	`NCT02525510` - Deceased Organ Donor Interventions to Protect Kidney Graft Function	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms