Active not recruitingPHASE2INTERVENTIONAL

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

This study, called CINERGY, investigates whether a medicine called tacrolimus can improve the success of kidney transplants. When an organ is transplanted, it can sometimes be damaged when blood flow is restored, leading to problems. Researchers believe that giving tacrolimus to organ donors who have brain death, before their organs are removed, might reduce this damage. This could help the new kidney work well from the start and last longer. Organ donors will either receive tacrolimus or a dummy medicine (placebo). The study then checks how well the donated kidneys work in the people who receive them, both in the short term (7 days) and long term (1 year). This initial 'pilot' study will help decide if a larger study is needed to confirm these findings.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Université de Sherbrooke

Enrolment target

414

Start

11 Jul 2022

Estimated completion

01 Jan 2026

Organ Transplant Failure or Rejection Brain Death Ischemic Reperfusion Injury

What is this study about?

Organ donation is a wonderful gift that saves and improves many lives. However, sometimes transplanted organs don't work as well as expected, and can even fail early on. This can happen because of what's called 'ischemia-reperfusion injury'. This is a medical term for damage that can occur when blood flow, which carries oxygen and nutrients, is stopped during the donation surgery and then restarted in the person receiving the organ.

When blood flow returns, it can cause swelling and inflammation in the new organ. If this damage is severe, it can make it harder for the organ to start working properly after the transplant. It can also increase the risk of the body rejecting the organ later, and might even shorten how long the transplanted organ lasts. The CINERGY study is looking into whether giving a medicine called tacrolimus to organ donors could help reduce this type of damage.

Tacrolimus is a medicine that helps calm the body's immune response. Researchers think that giving it to donors who have sadly passed away due to brain death, just before their organs are donated, might protect the organs from this injury. This pilot study aims to see if this idea is possible and safe, and to gather information that will help design a larger, more definitive study in the future across Canada.

Key takeaways

The study aims to improve success rates for kidney transplants.
It involves giving a medicine (tacrolimus) to organ donors to protect kidneys.
It's a pilot study, meaning it's a first step to see if a bigger study is needed.
Researchers will track how well transplanted kidneys work for up to a year.
The goal is to reduce early problems and help organs last longer.

Who may be eligible?

This study is for organ donors who are at least 18 years old and have been identified as having brain death. They must have agreed to be organ donors, and there needs to be at least one kidney from them going to a specific recipient in the study. All the people receiving organs from these donors will also be part of the study.

Donors wouldn't be able to take part if they have a known allergy to tacrolimus or one of its ingredients. Also, if any of their organs are going to a transplant program not involved in the study, or if a doctor feels tacrolimus isn't suitable for a particular recipient, they wouldn't be included. If any organ is going to a recipient under 18 years old, the donor wouldn't be part of this study either.

The people receiving the organs must be getting an organ from a donor included in this study. There are no other specific rules for who can't be a recipient in the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is the organ donor at least 18 years old?
Has the organ donor been sadly diagnosed with brain death?
Has consent been given for organ donation?
Is a kidney from the donor being given to a specific recipient in the study?
Is the organ recipient getting a kidney from a donor in this study?

Answer every question to see your result.

What does participation involve?

If an organ donor meets the study criteria, they would receive a single infusion of medicine (either tacrolimus or a dummy medicine) into their body before their organs are taken for transplant. This would happen 4 to 8 hours before the organ recovery procedure.

After transplantation, data will be collected from the people who received these kidneys. This involves monitoring their health and how well their new kidney is working for the first 7 days after the transplant. Then, follow-up information will be collected again at 12 months (one year) after the transplant to check on their general health, whether they needed another transplant, or if they needed dialysis. The total duration of involvement for recipients is up to 12 months.

Potential risks and benefits

This study is trying to find new ways to improve the success of organ transplants, which could potentially lead to better long-term health for people receiving organs. However, as with any medical study, there are potential risks, though these are mainly for the donor if they were alive and for the recipient. For the donor, if they were alive, there could be risks like allergic reactions or kidney problems from the medicine, but these are carefully monitored. For recipients, the tacrolimus administered to the donor is hoped to reduce transplant complications rather than cause them. You are always free to ask questions and discuss any concerns with your medical team, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (9)

Vancouver General Hospital
Verified postcode
Vancouver, Canada
St. Paul's Hospital
Verified postcode
Vancouver, Canada
L'Institut de Cardiologie de Montréal
Verified postcode
Montreal, Canada
Hôpital Maisonneuve-Rosemont
Verified postcode
Montreal, Canada
Centre Hospitalier Universitaire de Montréal
Verified postcode
Montreal, Canada
Centre universitaire de santé McGill (CUSM)
Verified postcode
Montreal, Canada
Centre Hospitalier Universitaire de Québec- Université Laval
Verified postcode
Québec, Canada
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
Verified postcode
Québec, Canada
Centre de recherche CHUS
Verified postcode
Sherbrooke, Canada

Common questions

What is brain death?

Brain death means that a person's brain has permanently stopped working. They cannot recover, and sadly, their body can only be kept functioning with machines. In the UK, a person who is brain dead is legally confirmed as being deceased.

What is tacrolimus?

Tacrolimus is a medicine commonly used after organ transplants to prevent the body from rejecting the new organ. In this study, it's being tested to see if giving it to the donor can protect the organ even before it's transplanted.

What is a placebo?

A placebo is a 'dummy' treatment that looks exactly like the real medicine but contains no active drug. It's used in studies to fairly compare the effects of the active medicine.

Why focus on kidney transplants?

Kidneys are commonly transplanted organs, and improving their success rate can make a big difference to many lives. The findings from kidney transplants might also help research into other organ transplants.

What is a 'pilot study'?

A pilot study is a small, early version of a larger study. It helps researchers test if their methods work, identify any problems, and see if a bigger study is worth doing.