Active not recruitingOBSERVATIONAL

PROACT Pilot Trial

This study, called PROACT Pilot, is for children under 19 who have had a kidney transplant. It's looking into a new urine test, called CXCL10, which might be better at finding early signs of the body rejecting the new kidney than current methods. When a kidney is rejected, it can get damaged and fail. At the moment, doctors mainly look at blood tests and sometimes do kidney biopsies (taking a tiny piece of the kidney for examination). These methods can sometimes miss early rejection or only find it after some damage has happened. This new CXCL10 test could help doctors spot rejection much sooner, allowing them to treat it quickly and protect the transplanted kidney. The study aims to see how well this test works in real life and help plan for a bigger study in the future.

At a glance

Status

Active not recruiting

Sponsor

University of British Columbia

Enrolment target

Start

01 Feb 2025

Estimated completion

31 May 2027

Kidney Transplant Rejection

What is this study about?

When someone has a kidney transplant, it's a life-changing operation. However, the body's immune system can sometimes see the new kidney as 'foreign' and try to attack it. This is called rejection. If rejection isn't caught and treated quickly, it can cause lasting damage to the kidney, and the new kidney might stop working. This can be particularly tough for children who have had kidney transplants, as nearly a third of them might experience their new kidney failing within five years, often due to rejection.

Currently, doctors mainly check for rejection using regular blood tests and sometimes kidney biopsies. Blood tests, like checking creatinine levels, can only show rejection once some damage has already happened to the kidney. Kidney biopsies involve taking a small piece of the kidney for examination, which can be uncomfortable and isn't done very often. This means that rejection can sometimes go unnoticed in its early stages, when it's much easier to treat.

This study is looking at a new test called CXCL10. This test can be done using a urine sample and has shown promise in earlier research for being able to detect rejection much earlier than current methods. The idea is that if doctors can spot rejection sooner, they can start treatment more quickly. This early treatment could save the kidney from damage, help it last longer, and improve the child's overall health and quality of life. This pilot study aims to understand how to best use this new test as part of regular care and help design a larger study in the future to confirm its benefits.

Key takeaways

A new urine test (CXCL10) is being explored for early kidney rejection detection.
The study focuses on children and young people who have had a kidney transplant.
Early detection of rejection could help protect the new kidney from damage.
Participation involves providing regular urine samples during routine appointments.
This is a 'pilot' study to prepare for a larger trial in the future.

Who may be eligible?

This study is for children and young people who have had a kidney transplant. To be part of the study, they must be under 19 years old when they received their transplant and have had their transplant at least six months ago. They also need to be able to continue coming for follow-up appointments for two years after they start using the new CXCL10 test.

There are some reasons why someone might not be able to join. For example, if they are expected to move to adult care within the next two years, or if they don't usually attend their regular transplant clinic appointments. Also, if they've had a recent rejection episode (within the last three months) or if their kidney function is very low, they won't be able to join this particular study. The doctors also need to be sure that urine samples can be collected reliably.

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 your child under 19 years old and has had a kidney transplant?
Has it been at least 6 months since your child's transplant?
Can your child attend follow-up appointments for the next two years?
Is your child's kidney function generally stable (not very low)?
Does your child regularly attend their transplant clinic appointments?

Answer every question to see your result.

What does participation involve?

If you or your child decides to take part in this study, the main change would be regularly providing urine samples for the new CXCL10 test. This test would be done at the same time as your usual clinic appointments. You would continue to have your regular blood tests and kidney check-ups as normal. The study wants to see how well the new urine test works alongside your usual care. The total duration of participation in the study is two years of monitoring with the new test.

Potential risks and benefits

Participating in this study might offer the benefit of potentially spotting kidney rejection earlier than with current methods, which could lead to quicker treatment and better outcomes for the transplanted kidney. The main 'risk' is that your child would need to provide regular urine samples. You don't have to take part, and if you do, you can withdraw at any time without it affecting your child’s usual medical care. The study will not involve any new medications or procedures beyond current standard of care and the urine testing.

Locations (3)

BC Children's Hospital
Verified postcode
Vancouver, Canada
The Children's Hospital of Winnipeg
Verified postcode
Winnipeg, Canada
The Hospital for Sick Children
Verified postcode
Toronto, Canada

Common questions

What is CXCL10?

CXCL10 is a new urine test that helps doctors look for very early signs of kidney rejection in people who have had a kidney transplant.

Why is this study important for children?

Children who have had kidney transplants are at a higher risk of losing their new kidney, often due to rejection. This study aims to help doctors find and treat rejection sooner, which could save their kidney.

Will my child need more medical appointments if we join?

No, the new urine tests will usually happen during your child's routine hospital visits, so it shouldn't mean extra trips to the clinic.

Will my child have to take new medicines?

No, this study is about a new way to monitor for rejection, not about new medications. Your child will continue with their usual transplant medicines and care.

What if we decide not to join the study?

That's completely fine. Your child will still receive the best possible care for their kidney transplant, just as before. Your decision won't affect their treatment in any way.