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

NCT ID NCT01672164

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 are studying blood, urine, and tissue samples from people who have received a liver transplant to find early biological signs of organ rejection and liver scarring. The goal is to develop simple tests that detect these problems sooner than current methods, which often rely on invasive biopsies. The study follows about 200 liver transplant recipients over time, collecting samples to identify proteins and gene activity linked to rejection, treatment response, and kidney damage.

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 the biomarker panels work, doctors could detect liver rejection earlier through simple blood or urine tests, potentially improving organ survival and reducing the need for invasive biopsies.
What could go wrong
This is an observational study, not a treatment trial, so it cannot directly cure or prevent rejection. Biomarkers found in this group may not generalise to all transplant patients, and years of validation would be needed before any test reaches the clinic.

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

202 people

The number who actually took part.

Start date

Aug 2012

Finished

Dec 2015

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

Liver Transplant Recipients

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 deceased-donor or living donor liver transplantation; * Subject must be able to understand and provide informed consent. Exclusion Criteria: * Need for combined organ transplantation; * Previous solid organ and/or islet cell transplantation; * Infection with HIV; * Allergy to iodine; * Inability or unwillingness of a participant to 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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As listed by the trial registrant

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

Liver transplant recipients Liver transplantation

Contacts and locations

Locations

  • Baylor University Medical Center

    Dallas, Texas, 75246, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44295, United States

  • Mayo Clinic

    Phoenix, Arizona, 85054, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Mount Sinai School of Medicine

    New York, New York, 10029, United States

  • Northwestern University, Feinberg School of Medicine

    Chicago, Illinois, 60611, United States

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