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Can a blood test catch kidney rejection before damage sets in?

NCT ID NCT01289717

Diagnosis Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 25, 2026 · Last updated Sep 25, 2026

Summary

Researchers want to find blood and urine tests that detect early signs of rejection in people who have received a kidney transplant. The study follows about 307 kidney transplant recipients, collecting blood, urine, and kidney tissue samples over time. By studying gene patterns in these samples, researchers hope to diagnose rejection, scarring, and other complications earlier and improve how long transplanted kidneys survive.

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 it works, this could lead to simple blood or urine tests that spot kidney rejection earlier, when treatment is more likely to save the transplanted organ.
What could go wrong
Finding reliable gene markers is hard, and markers that show up in a study may not work well in routine care. This is an observational study, so it does not test a treatment.

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

307 people

The number who actually took part.

Start date

Mar 2011

Finished

Jun 2016

Lead sponsor

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

Adults undergoing kidney transplantation.

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: * Subjects undergoing primary or subsequent deceased-donor or living donor kidney transplantation * Subject and/or parent guardian must be able to understand and provide informed consent * Female subjects of childbearing potential must have a negative pregnancy test within 6 weeks of study entry. Exclusion Criteria: * Need for combined organ transplantation with an extra-renal organ and/or islet * Recipient of previous non-renal solid organ and/or islet cell transplantation * Infection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV) * Inability or unwillingness of a participant to give written informed consent or comply with study protocol * Any condition that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.

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Conditions

The condition(s) this trial relates to.

pulmonary fibrosis

As listed by the trial registrant

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

Kidney transplant Kidney transplantation

Contacts and locations

Locations

  • Mayo Clinic, Division of Nephrology

    Phoenix, Arizona, 85054, United States

  • Medical University of South Carolina, Division of Transplant

    Charleston, South Carolina, 29425, United States

  • Northwestern University, Feinberg School of Medicine, Division of Organ Transplantation

    Chicago, Illinois, 60611, United States

  • The Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • The Scripps Research Institute, Scripps Center for Organ and Cell Transplantation,

    La Jolla, California, 92037, United States

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