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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorUniversity of British Columbia

About 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

Qualifiers

Patients ≥ 19 years old with a failed first kidney transplant and planned dialysis start date.

Disqualifiers

Previous extra-renal organ transplant, or more than one previous kidney transplant

Not prescribed tacrolimus or cyclosporine at the time of transplant failure

Active infection or cancer that precludes IMSN, or non-transplant indication to continue IMSN

Receipt of an HLA identical donor transplant kidney with low risk for sensitization

Trial design

Treatments tested in this trial

  • Prevention of Allosensitization

Treatment groups

96 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of British Columbia

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator