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Pee power: urine test may spare kids painful kidney biopsies

NCT ID NCT03719339

Knowledge-focused Sponsor: Children's Hospital of Philadelphia 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times

Summary

This study is testing whether a simple urine test can detect signs of kidney transplant rejection in children. Researchers are looking for specific molecules in urine that signal the body is attacking the new kidney. If the test works, it could help doctors spot problems early without needing a needle biopsy. The study involves 445 children aged 2 to 18 who have had a kidney transplant.

What this could mean

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

What this could lead to
If successful, this could lead to a non-invasive urine test to monitor kidney transplant health in children, replacing some painful biopsies.
What could go wrong
This is an observational study, not a treatment trial. The urine test may not be accurate enough to replace biopsies, and results may not apply to all children.

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

445 people

The number who actually took part.

Started

Aug 2017

Finished

Apr 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

Subjects 2 to 18 years of age meeting inclusion criteria will be recruited from the participating sites' Nephrology outpatient clinics or inpatient settings. All sites may choose to enroll Spanish speaking subjects pending the site has necessary resources to translate/interpret study related information. Sites choosing to enroll Spanish speaking subjects will have a native speaking translator or interpreter available to prevent any miscommunication during the consent process.

Ages

2 to 18 years

Sex

Anyone

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: * Males or females between 2 to 18 years at the time of recruitment * Receiving the first, or additional, incident kidney transplants. * Have an existing/prevalent transplant with a scheduled kidney allograft biopsy. * Parental/guardian permission (informed consent) and, if appropriate, child assent. Exclusion Criteria: • Patient's primary medical team feels the subject's participation is not safe.

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Conditions

The condition(s) this trial relates to.

acute transplant rejection BK-virus nephropathy chronic kidney disease end stage renal failure kidney disorder transplant rejection

As listed by the trial registrant

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

Acute cellular graft rejection Antibody-mediated rejection BK virus nephropathy End-stage renal disease Nephropathy Pediatric kidney disease Renal transplant rejection

Contacts and locations

Locations

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611, United States

  • CHOP

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027, United States

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010-291, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Joan & Sanford I. Weill Medical College of Cornelle University

    New York, New York, 10065-4805, United States

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • Stanford University

    Palo Alto, California, 94304, United States

  • University of California

    Los Angeles, California, 90095, United States

  • University of California-San Diego, Rady Children's Hospital

    La Jolla, California, 92093-0894, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Vancouver Children's Hospital

    Vancouver, British Columbia, V6T 1Z3, Canada

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