Urine CXCL10 Monitoring for Kidney Transplant Rejection

Recruiting in Palo Alto (17 mi)

+8 other locations

Overseen byJulie Ho, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: University of Manitoba

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This is a Phase II-III multi-center prospective randomized controlled clinical trial of incident adult renal transplant patients. The primary objective of this study is to determine if the early treatment of rejection, as detected by urinary CXCL10, will improve renal allograft outcomes.

Eligibility Criteria

Adults over 18 who've recently had a kidney transplant can join this trial. They must understand the study, agree to follow its rules, and be available for its duration. Participants need an elevated urine CXCL10 level without infection or significant bleeding in their urine. Those with certain immune mismatches, other organ transplants, conditions affecting safe participation or data quality, incompatible blood types, high antibody levels against the donor kidney, or not following standard anti-rejection drugs cannot join.

Inclusion Criteria

Participants must be able to understand and provide written informed consent

Confirmed elevated urine CXCL10:Cr without a urinary tract infection or gross hematuria.

Stated willingness to comply with all study procedures and availability for the duration of the study

+2 more

Exclusion Criteria

I have antibodies against the transplant donor.

I have had an organ transplant.

My organ transplant has failed to work.

+7 more

Participant Groups

The trial is testing if treating kidney transplant rejection early based on urinary CXCL10 levels improves long-term outcomes of the new kidney. It's a controlled study where some patients will receive treatment based on these biomarker levels while others may follow standard care protocols.

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

Participants with high urine CXCL10 randomized to the Intervention Arm will undergo a kidney transplant biopsy to check for rejection. Biopsy-proven subclinical rejection will be treated per study protocol.

Group II: ControlActive Control1 Intervention

Participants with high urine CXCL10 randomized to the Control Arm will continue routine post-transplant surveillance with serum creatinine and proteinuria; serial urine samples will continue to be collected and analyzed (blinded), but not used to direct care.