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Simple blood test could replace biopsies for kidney transplant patients

NCT ID NCT07551531

Diagnosis Sponsor: Insight Molecular Diagnostics 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 31, 2026 · Updated 2 times

Summary

This study will test a new blood test called GraftAssure that measures DNA from the donor kidney in the recipient's blood. The goal is to see if this test can detect rejection more accurately than current methods. Researchers will enroll 5,000 kidney transplant patients and follow them over time. If the test works well, it could help doctors catch rejection earlier and avoid some invasive biopsies.

What this could mean

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

Active substance
GraftAssure blood test (measures donor-derived cell-free DNA)
What this could lead to
If successful, this test could help doctors detect kidney rejection earlier and more accurately, potentially reducing the need for invasive biopsies.
What could go wrong
This is an observational registry study, not a treatment trial. The test may not prove superior to existing methods, and results may not change patient outcomes.

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

About 5,000 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 2033

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult kidney transplant recipients across up to 60 student centers in the United States.

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: Prospective Participant 1. 18 years of age or older. 2. ≥ 2 weeks post-kidney transplant at the time of first sample collection. 3. Provides legally effective informed consent. 4. Agrees to comply with all study procedures. Inclusion Criteria: Historical Control Participant 1. 18 years of age or older 2. Has a minimum of three clinical evaluations per year post-transplant. Exclusion Criteria: Prospective Participant 1. Has received transplanted kidney from their identical twin. 2. Has a history of another previously transplanted organ in situ, other than a prior kidney transplant. 3. Has received an allogenic bone marrow graft or hematopoietic stem cell transplantation (HSCT). 4. Self-reports as pregnant. 5. Has a current malignancy, other than low-grade malignancy. 6. Actively enrolled in another cfDNA assay-based trial. 7. In the opinion of the investigator, participation in this study would pose a risk to data integrity or to the participant's safety and welfare. Exclusion Criteria: Historical Control Participant 1. Has received a kidney transplant from their identical twin. 2. Has a history of another previously transplanted organ in situ, excluding previous kidney transplant. 3. Has a current malignancy, other than low-grade malignancy. 4. Self-reported pregnancy during the historical data time period.

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Conditions

The condition(s) this trial relates to.

Rejection, Psychology

As listed by the trial registrant

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

Kidney transplant

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cooperman Barnabas Medical Center

    Livingston, New Jersey, 07039, United States

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