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Urine test may outsmart blood test for kidney rejection

NCT ID NCT07415876

Diagnosis Sponsor: Virginia Commonwealth University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 16, 2026 · Updated 3 times

Summary

This study tests whether a urine test for a protein called CXCL10 can catch kidney transplant rejection that a standard blood test misses. Researchers will compare the urine test to biopsy results in 50 kidney transplant patients. They will also check if the urine samples can be shipped at room temperature without affecting accuracy.

What this could mean

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

Active substance
urinary CXCL10 test
What this could lead to
If successful, this could lead to a more accurate, non-invasive urine test for kidney transplant rejection, reducing the need for biopsies.
What could go wrong
This is a small, early-stage study (50 participants) focused on diagnostic accuracy, not treatment. The test may not prove reliable enough for widespread use.

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.

Participants

20 people

The number who actually took part.

Started

Jun 2026

Finished

Jul 2026

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.

Who is studied

A total of 50 kidney transplant recipients will be included in this study: * 20 retrospective subjects: will be selected from the HM20019578 VCU Kidney Transplant Prospective Registry. These individuals have biopsy-confirmed acute rejection with dd-cfDNA\<1% results. Frozen urine aliquots previously biobanked from these subjects will be used for CXCL10 testing. * 30 prospective subjects: will be enrolled at the time of a clinically indicated kidney biopsy. A single urine sample will be collected during the biopsy visit and immediately split into two equal aliquots. One aliquot will be stored and transported under refrigerated conditions, while the other will be kept under ambient conditions. Both samples will be shipped simultaneously to One Lambda for CXCL10 testing.

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.

Prospective Inclusion Criteria: * Age ≥18 years * Undergoing a clinically indicated biopsy * Able to provide informed consent * Willing to provide a urine sample and allow access to relevant clinical Retrospective Inclusion Criteria: * Age ≥18 years * Biopsy-confirmed rejection (positive histology) * Donor-derived cell-free DNA\<1% result at time of biopsy * Availability of stored urine sample collected at time of biopsy Exclusion Criteria (applies to both arms): * Individuals under 18 years of age * Individuals unable to provide informed consent (for prospective enrollment) * Pregnant women * Prisoners * Adults unable to consent

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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 rejection

Contacts and locations

Locations

  • Virginia Commonwealth University

    Richmond, Virginia, 23298, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.