Prevent Allosensitization in Patients Who Have Failed a First Renal Transplant (PART)

Condition(s) studied

Investigational drug(s) / intervention(s)

Prevention of Allosensitization: This study evaluates the impact of two different durations of immunosuppressive therapy on kidney transplant patients who return to dialysis after a failed transplant. One group will continue immunosuppressive therapy for two years, while the other will stop the therapy six months after starting dialysis. The goal is to determine if continuing immunosuppression can reduce the risk of allosensitization and improve outcomes, compared to stopping the therapy earlier.

Study summary

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

Primary outcome measure(s)

• A clinically relevant increase in sensitization — From enrollment to the study at 24 months
  A clinically relevant increase in sensitization defined as an increase in sensitization that decreases the number of HLA compatible donors that a patient can receive a transplant from by at least 50%, is the primary outcome for the future definitive PART Trial.

Trial sites (1)

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