Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New DNA test may spot kidney rejection without a needle

NCT ID NCT07060716

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether a donor-derived cell-free DNA (dd-cfDNA) test can accurately detect rejection in kidney transplant recipients. Researchers will compare the test results to standard biopsy findings in 125 adults who are at least 12 days post-transplant. If the test works well, it could offer a less invasive way to monitor transplant health.

What this could mean

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

Active substance
donor-derived cell-free DNA test
What this could lead to
If successful, this test could offer a simpler, less invasive way to monitor kidney transplant health and catch rejection early.
What could go wrong
This is an observational study, not a treatment trial. The test may not be accurate enough to replace biopsies, and results may vary across patients.

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 125 people

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

Started

Sep 2025

Expected to finish

Dec 2025

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

Individuals who have received a kidney transplant at centers in the United States and Germany will be invited to participate.

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: 1. Subject is 18 years of age or older 2. At least 12 calendar days have elapsed since the subject received a kidney transplant. 3. Subject has provided legally effective informed consent 4. Subject agrees to comply with all study procedures Exclusion Criteria: 1. Kidney donor is an identical twin of the subject. 2. The subject has another previously transplanted organ in situ. 3. Subject has received a hematopoietic stem cell transplant. 4. Subject has received a bone marrow graft. 5. Subject has self-reported as pregnant. 6. In the opinion of the investigator, the subject's participation in the study would pose a risk to data integrity or to the subject's safety and welfare. Sample Inclusion Criteria: 1\. A graft biopsy is obtained within ±1 week of blood draw. * If blood draw is obtained after biopsy, blood draw should be taken at least 2 days after an uncomplicated biopsy procedure. Sample Exclusion Criteria: 1. Sample collected from someone that had an invasive graft biopsy ≤ 48 hours prior to blood draw. 2. Sample collected from subject that received immunosuppressive treatment for biopsy-proven acute rejection ≤ 30 days prior to blood draw 3. Sample collected from subject that received a blood transfusion ≤ 30 days prior to blood draw. 4. Sample collected from a subject that provided another sample for the study within the past 7 days.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Cell free DNA are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

transplant rejection

As listed by the trial registrant

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

Cell free DNA Kidney transplant rejection

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    6 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • Baylor, Scott & White Research Institute

    RECRUITING

    Dallas, Texas, 75246, United States

  • Charite Universitatsmedizin

    ACTIVE_NOT_RECRUITING

    Berlin, 10117, Germany

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Institute of Immunology - Transplantation Immunology

    ACTIVE_NOT_RECRUITING

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • Intermountain Health

    RECRUITING

    Murray, Utah, 84107, United States

  • Mayo Clinic in Florida

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Tampa General Hospital

    RECRUITING

    Tampa, Florida, 33606, United States

    Contact Email: •••••@•••••

  • University of Pittsburgh Medical Center

    ACTIVE_NOT_RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Southern California Keck School of Medicine

    ACTIVE_NOT_RECRUITING

    Los Angeles, California, 90033, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.