PROACT Pilot Trial (NCT06564649) | Clinical Trial Compass
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 range
6 Months – 18 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Capacity of Recruitment for future definitive trial