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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Prevention of Allosensitization

    Drug

    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.

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Arm 1Experimental treatment 1 intervention
Group B: Arm 2Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

A clinically relevant increase in sensitization

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.

Time frame
From enrollment to the study at 24 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of British Columbia

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: