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Urine test may catch kidney rejection before it's too late

NCT ID NCT03206801

Disease control Sponsor: University of Manitoba Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether monitoring a substance in urine called CXCL10 can help detect kidney transplant rejection earlier. 260 adult kidney transplant patients were randomly assigned to either have their CXCL10 levels checked or receive standard care. If CXCL10 was high, patients got a biopsy to check for rejection. The goal was to see if early detection and treatment could improve kidney survival and function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
urine CXCL10 monitoring (a urine test to detect early signs of rejection)
What this could lead to
If successful, this approach could help doctors detect kidney transplant rejection earlier, potentially preventing long-term damage and improving graft survival.
What could go wrong
This is a mid-stage trial, so results may not be definitive. The test may not reliably predict rejection in all patients, and early treatment might not improve overall outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

260 people

The number who actually took part.

Started

Apr 2018

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participants must be able to understand and provide written informed consent 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. All ethnic and gender groups will have equal access to the study 4. Incident adult (age ≥18) renal transplant patients with a living or deceased donor kidney transplant 5. Confirmed elevated urine CXCL10:Cr without a urinary tract infection or gross hematuria. Exclusion Criteria: 1. Primary non-function 2. Blood group (ABO) incompatible 3. Pre-transplant donor specific antibody (DSA) positive (MFI\>1000 OR positive flow crossmatch) 4. Human leukocyte (HLA) 0 HLA antigen D-related (DR) + 0 major HLA class 2 (DQ) mismatch 5. Presence of other transplanted organ or co-transplanted organ 6. Medical contraindication to biopsy or rejection treatment 7. Followed outside of investigational center 8. Participation in other interventional trials within 4-weeks post-transplant or anytime post-transplant till study end at 12-months 9. Intention to not use a maintenance immunosuppression regimen consisting of calcineurin inhibitor (CNI) and anti-proliferative agents 10. Any condition that, in the opinion of the investigator, would pose risk to the subject's safe participation, or interfere with their ability to comply with the study requirements, or may impact the quality of interpretation of the data.

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Conditions

The condition(s) this trial relates to.

transplant rejection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Kidney transplant; complications Rejection of renal transplant

Contacts and locations

Locations

  • Centre de recherche du CHUM (CRCHUM)

    Montreal, Quebec, Canada

  • McGill

    Montreal, Quebec, Canada

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • University Health Network, University of Toronto

    Toronto, Ontario, Canada

  • University of Calgary

    Calgary, Alberta, Canada

  • University of Manitoba, Transplant Manitoba Adult Kidney Program

    Winnipeg, Manitoba, R3A 1R9, Canada

  • University of Ottawa

    Ottawa, Ontario, Canada

  • Université Laval

    Québec, Quebec, Canada

  • Western University

    London, Ontario, Canada

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