Urine test may replace biopsies for kidney transplant patients
NCT ID NCT00337220
First seen Sep 25, 2026 ยท Last updated Sep 25, 2026
Summary
Researchers are studying whether analyzing urine samples for specific molecular markers can predict rejection in people who receive kidney transplants. The trial enrolls adults scheduled for kidney transplantation and follows them to see if the urine test matches biopsy results. The goal is to develop a noninvasive way to monitor transplant health and catch rejection early.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- urine test measuring mRNA markers
- What this could lead to
- If it works, this could give doctors a simple urine test to spot kidney transplant rejection early, reducing the need for invasive biopsies.
- What could go wrong
- The markers may not reliably predict rejection in all patients, and the test could miss cases or give false alarms. Larger studies are needed to confirm its accuracy.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
-
492 people
The number who actually took part.
- Start date
-
Jun 2006
- Finished
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Dec 2010
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients who have recently undergone kidney transplant
- Ages
-
Up to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Scheduled to undergo primary or redo deceased- or living-donor kidney transplantation * Ability to provide informed consent Exclusion Criteria: * Requires combined organ transplantation * Previously received a solid organ transplant (other than kidney transplant) or islet cell transplant * HCV infected * HIV infected
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Columbia University
New York, New York, 10032, United States
-
Cornell University
New York, New York, 10021, United States
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Northwestern University
Chicago, Illinois, 60611, United States
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University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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University of Wisconsin
Madison, Wisconsin, 53792, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- The rare transplant patients who quit Anti-Rejection drugs: can a blood test find others like them?
- Can a blood test catch kidney rejection before damage sets in?
- Can early blood tests predict Five-Year kidney transplant success?
- Can a donor Organ's gene signature foretell rejection?
- Can simple tests replace biopsies for kidney transplant patients?
- Can a new drug cocktail keep kidney transplants healthy without steroids or tacrolimus?