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Blood test may spare kidney transplant patients from painful biopsies

NCT ID NCT06406179

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether a blood test that measures donor DNA (dd-cfDNA) can safely guide follow-up care for kidney transplant patients, potentially reducing the need for invasive biopsies. 500 adult kidney transplant recipients will be randomly assigned to standard care or a strategy where doctors use dd-cfDNA results to decide whether a biopsy is needed. The goal is to see if this approach maintains kidney function while avoiding unnecessary procedures.

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 (dd-cfDNA) blood test
What this could lead to
If successful, this could reduce the need for invasive biopsies in kidney transplant patients, making monitoring safer and more comfortable.
What could go wrong
This is a Phase 2-like trial with 500 participants, so results may not apply to all patients. The blood test may not catch all rejection cases, and some biopsies may still be needed.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 500 people

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

Started

May 2025

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

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: * All men and women, age ≥18 years old. * Subject must be a recipient of a non-combined renal transplant from a deceased or living donor. It can be a re transplantation after a graft loss of function or graft rejection * Subject is willing and able to provide signed written informed consent and willing to comply with study procedures * Women of Childbearing Potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized. Exclusion Criteria: * Subjects who are legally detained in an official institution or under legal protection * Any condition that, in the opinion of the investigator, might interfere with the patient 's participation in the study, poses an added risk for the patient, or confounds the assessment of the patient * History of multi-organ transplant (interference with rejection natural history).

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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.

Renal transplantation

How to take part

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

  1. The places running it

    3 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

  • AP-HP - Hôpital Tenon

    ACTIVE_NOT_RECRUITING

    Paris, France

  • CHU Toulouse

    NOT_YET_RECRUITING

    Toulouse, France

  • Georges Pompidou European Hospital

    ACTIVE_NOT_RECRUITING

    Paris, 75015, France

  • Hopital Saint Louis

    RECRUITING

    Paris, Île-de-France Region, 75010, France

  • Hôpital Necker-Enfants Malades

    ACTIVE_NOT_RECRUITING

    Paris, 75015, France

  • Hôpital de la Salpêtrière hôpital à Paris

    RECRUITING

    Paris, Île-de-France Region, 75013, France

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