Active — Not RecruitingNot Applicable

PROACT Pilot Trial

Canada60 participantsStarted 2025-02-01

Plain-language summary

Kidney transplantation is considered the best option to treat end-stage kidney disease, but the recipient's immune system may respond with rejection to the transplanted organ, leading to permanent kidney damage and failure. The current standard for rejection monitoring in transplanted recipients is regular blood creatinine testing and kidney biopsies. Creatinine doesn't detect rejection until damages had occurred, causing some amount of kidney failure, and kidney biopsies are only done at set timepoints. A new test called CXCL10 is shown to be more effective in detecting rejection from previous research and can be done as often as needed. Therefore, The investigators are doing this randomized trial to test CXCL10 as part of clinical care and to help design a larger national clinical trial in the future.

Who can participate

Age range6 Months – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Prevalent pediatric kidney transplant recipients (\<19 years at transplantation) who are more than 6 months after transplant, with informed consent and assent. * Must be available to follow-up for two years after initiation of urinary CXCL10 monitoring Exclusion Criteria: * Expected transfer to adult care in the next 2 years. * In center routine follow-up interval \>3 months between visits * Non-adherence to routine transplant clinic visits. * Recent acute rejection episode in the last 3 months prior to enrolment. Patients may be enrolled if rejection was more than 3 months prior to enrolment. No exclusion for donor-specific antibody in the absence of acute cellular or antibody-mediated rejection. * Estimated glomerular filtration rate \<30 ml/min/1.73m2 (stage IV/V CKD). * Inability to reliably obtain urinary samples for monitoring purposes. * Contraindication to kidney biopsy.

What they're measuring

Capacity of Recruitment for future definitive trial

Timeframe: 8 months

Trial details

NCT IDNCT06564649

SponsorUniversity of British Columbia

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-10-31