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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Page 1 of 1 (3 locations)

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