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

NCT06802822 | Not Yet Recruiting DMC

• 1 other identifier: H24-02541
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Transplant; Kidney Transplant Failure; Immunosuppresion

Keywords

kidney transplant; kidney transplant failure; immunosuppression; sensitization

Outcome Measures

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.

  From enrollment to the study at 24 months

Study Arms (2)

Arm 1

EXPERIMENTAL

Patients will withdraw from immunosuppressant after 6 months post dialysis initiation

Drug: Prevention of Allosensitization

Arm 2

ACTIVE COMPARATOR

Patients will withdraw from immunosuppressant after 24 months post dialysis initiation

Drug: Prevention of Allosensitization

Interventions

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.

Arm 1; Arm 2

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Patients without archived donor samples to determine eplet mismatch and donor specific antibodies
• Planned nephrectomy of the failed allograft
• Graft survival of ≤ 12 months due to rejection
• Designated as non-repeat transplant candidates by their transplant center or cPRA ≥ 90% at the time of enrollment in whom further increase in cPRA may permanently preclude repeat transplantation
• Planned living donor transplant or planned move away from study center

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Kidney Transplant Research

Vancouver, British Columbia, V6Z1Y6, Canada

Location

Central Study Contacts

Gurvir Thind

CONTACT

604-441-1102; gthind@providencehealth.bc.ca

Breanna Riou-Green

CONTACT

604-682-2344; briougreen@providencehealth.bc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Transplant Nephrologist

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 31, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)