Calcineurin Inhibitor in NEuRoloGically Deceased Donors to Decrease Kidney delaYed Graft Function… (NCT05148715) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Calcineurin Inhibitor in NEuRoloGically Deceased Donors to Decrease Kidney delaYed Graft Function (CINERGY)
Canada414 participantsStarted 2022-07-11
Plain-language 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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Organ donor accrual rates
Timeframe: 6 to 12 months after the beginning of the trial
2
Recipient consent rate
Timeframe: 6 to 12 months after the beginning of the trial