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New blood test could spare kidney patients painful biopsies

NCT ID NCT07006831

Knowledge-focused Sponsor: Devyser Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 21, 2026 · Updated 2 times

Summary

This study collects blood samples from 400 kidney transplant patients who need a biopsy. Researchers will use the samples to develop a non-invasive test that measures donor DNA in the blood to check the health of the transplanted kidney. The goal is to replace invasive biopsies with a simple blood draw.

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 successful, this could lead to a simple blood test to check if a kidney transplant is healthy, reducing the need for invasive biopsies.
What could go wrong
This is an early-stage sample collection study, not a treatment trial. The test may not prove accurate or may not be developed further.

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 400 people

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

Started

Nov 2025

Expected to finish

Mar 2028

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

Kidney 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: 1. Willing and able to provide written informed consent 2. Is 18 years of age or older at enrollment 3. Had a kidney transplant prior to enrollment 4. Is having an indication (for cause) biopsy as determined by clinician 5. retrospective leftover samples are available from the kidney donor(s). Exclusion Criteria: 1. Is pregnant 2. Had a blood transfusion within the past 4 weeks 3. Had a transplant from an identical (monozygotic) twin 4. Had transplants of multiple organs from the same donor (eg, kidney and liver transplant). 5. Had transplants of more than 2 organs from different donors (eg, recipient of a third kidney transplant) 6. Had a transplant of hematopoietic stem cells (eg, bone marrow) or tissue (eg, heart valve)

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Conditions

The condition(s) this trial relates to.

impaired renal function disease kidney disorder

As listed by the trial registrant

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

Cell free DNA Kidney disease Kidney transplant NGS Renal function Transplant recipient

How to take part

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

  1. The places running it

    5 sites. 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

  • Brigham & Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Piedmont Healthcare

    RECRUITING

    Atlanta, Georgia, 30309, United States

  • Scripps Health

    RECRUITING

    San Diego, California, 92037, United States

  • University of California San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Maryland Baltimore

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Utah

    COMPLETED

    Salt Lake City, Utah, 84132, United States

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