Immunosuppressants for Kidney Transplant

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of British Columbia

No Placebo Group

Trial Summary

What is the purpose of this trial?Kidney transplant is often the best treatment for people with kidney failure, but transplanted kidneys don't always last a lifetime. Many transplanted kidneys fail within 12 years, leaving patients needing dialysis or another transplant. One major issue is something called "allosensitization," which happens when the immune system attacks the donated kidney due to foreign markers on the kidney. This makes it harder to match a patient with another donor kidney in the future. To try to prevent this, patients are given immunosuppressants (drugs that weaken the immune system) after a transplant to stop the immune system from attacking the new kidney. However, after a kidney transplant fails and patients return to dialysis, there's no clear evidence that continuing immunosuppressants helps prevent allosensitization. Plus, these drugs have serious risks, including infections, heart disease, and even cancer. The PART study is a pilot study designed to explore whether continuing immunosuppression after a failed transplant for two years (instead of stopping after six months) can lower the risk of allosensitization and whether it is safe to do so. This pilot will also gather data that will be used for a larger trial in the future. The study will be done at 12 different research centers, and around 96 patients will be enrolled in the pilot trial. The ultimate goal is to better understand if continuing immunosuppressants after transplant failure can make a difference, and whether it's safe enough to proceed to a larger, more definitive trial.

Eligibility Criteria

The PART study is for patients who have had a kidney transplant fail and are now back on dialysis. It's to see if staying on immune-weakening drugs longer can prevent the body from rejecting future transplants. Participants must be adults who've recently had their first kidney transplant fail.

Inclusion Criteria

I am 19 or older, my first kidney transplant failed, and I am planning to start dialysis.

Exclusion Criteria

I am not taking tacrolimus or cyclosporine after my transplant failed.

I do not have an infection or another cancer that stops me from continuing my current treatment.

I don't have saved samples for transplant matching tests.

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Participant Groups

This pilot trial tests whether continuing immunosuppressants for two years after a failed kidney transplant reduces allosensitization, compared to stopping at six months. The safety of prolonged use will also be assessed across 12 research centers with about 96 participants.

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 1Experimental Treatment1 Intervention

Patients will withdraw from immunosuppressant after 6 months post dialysis initiation

Group II: Arm 2Active Control1 Intervention

Patients will withdraw from immunosuppressant after 24 months post dialysis initiation