Status:
ACTIVE_NOT_RECRUITING
PROACT Pilot Trial
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
University of Toronto
University of Manitoba
Conditions:
Kidney Transplant Rejection
Eligibility:
All Genders
6-18 years
Brief 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 kid...
Detailed Description
Kidney transplant offers hope to thousands of people living with chronic kidney disease, but the average five-year-old who gets a kidney transplant should expect to need a second transplant before the...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06564649
Start Date
February 1 2025
End Date
May 31 2027
Last Update
June 15 2025
Active Locations (3)
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1
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3N1
2
The Children's Hospital of Winnipeg
Winnipeg, Manitoba, Canada, R3E 3P4
3
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1E8