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Blood test may spot kidney transplant rejection without a biopsy

NCT ID NCT07805343

Diagnosis Sponsor: Paris Translational Research Center for Organ Transplantation 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This study tests whether a blood test measuring donor-derived cell-free DNA can reliably detect kidney transplant rejection. Researchers will compare the test results with kidney biopsy findings in 5,000 transplant recipients across multiple countries. The goal is to see if this noninvasive test works well across different patient groups and types of rejection, which could eventually reduce the need for 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
Donor-derived cell-free DNA blood test
What this could lead to
If it works, this blood test could help doctors spot kidney transplant rejection earlier and more accurately, possibly reducing the need for invasive biopsies.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly change care. The test's accuracy may vary across different patient groups and rejection types, and it might not outperform current methods in all cases.

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.

Started

Jun 2024

Expected to finish

Dec 2026

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.

Who is studied

Kidney transplant recipients of all age and sexes with at least one kidney biopsy performed concurrently with dd-cfDNA measurement.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Recipients transplanted from a deceased or living donor * Kidney allograft biopsy concomitantly with dd-cfDNA measurement * Written informed consent at the time of transplantation for inclusion the center database Exclusion Criteria: * Combined organ transplantation * Pregnant women * Grafts from monozygotic twins * Recipient of a bone marrow transplant

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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.

Kidney rejection transplant Rejection acute renal Rejection chronic renal Transplantation

Contacts and locations

Locations

  • 11- Pediatric Nephrology Department, Robert-Debré Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France

    Paris, France

  • Cleveland Clinic, 2050 East 96th Street, Cleveland, OH

    Cleveland, Ohio, 44195-0001, United States

  • Department of Medicine, Division of Nephrology, Comprehensive Transplant Center, Cedars-Sinai Medical Center, Los Angeles, CA, USA

    Los Angeles, California, 90048, United States

  • Department of Medicine, Division of Nephrology, University of Texas Southwestern Medical Center, Dallas, Texas, USA

    Dallas, Texas, 75390-8856, United States

  • Department of Medicine, Division of Nephrology, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.

    Madison, Wisconsin, 53705, United States

  • Department of Nephrology and Dialysis, Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Cité, Paris, France

    Paris, 75015, France

  • Department of Nephrology and Internal Intensive Care Medicine, Charité Universitätsmedizin Berlin

    Berlin, Germany

  • Department of Nephrology and Renal Transplantation, University Hospitals Leuven, Leuven, Belgium

    Leuven, Belgium

  • Department of Nephrology, Tampa General Hospital, Tampa, FL, USA

    Tampa, Florida, 33606, United States

  • Department of Nephrology-Dialysis-Transplantation, CHU de Toulouse, Toulouse, France

    Toulouse, France

  • Department of Pediatrics, Comprehensive Transplant Center, Cedars-Sinai Medical Center, Los Angeles, California, USA.

    Los Angeles, California, 90048, United States

  • Division of Nephrology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea

    Seoul, South Korea

  • Division of Nephrology, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA

    Los Angeles, California, 90095, United States

  • Division of Nephrology, Department of Medicine, University of Utah Health, Salt Lake City, UT, USA

    Salt Lake City, Utah, 84132, United States

  • Division of Nephrology, Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA

    St Louis, Missouri, 63110, United States

  • Division of Nephrology, Virginia Commonwealth University, Richmond, VA, USA

    Richmond, Virginia, 23219, United States

  • Division of Nephrology, Weill Cornell Medical College, NewYork-Presbyterian Hospital, New York, NY, USA

    New York, New York, 10065, United States

  • Division of Pediatric Nephrology, Emory University School of Medicine, Atlanta, GA, USA

    Atlanta, Georgia, 30322, United States

  • Division of Pediatric Nephrology, Washington University School of Medicine and St. Louis Children's Hospital, St. Louis, MO, USA

    St Louis, Missouri, 63110, United States

  • Hôpital Necker

    Paris, France

  • Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris;

    Paris, France

  • Nephrology Division, Hospital do Rim, Fundação Osvaldo Ramos, Federal University of São Paulo, São Paulo, Brazil

    São Paulo, Brazil

  • Service de Néphrologie, Département de Médecine, Hôpitaux Universitaires de Genève, Geneva, Switzerland

    Geneva, 1205, Switzerland

  • Translational Nephrology and Kidney Transplant Research Laboratory, Vall d'Hebron Research Institute (VHIR), Barcelona, Spain

    Barcelona, Spain

  • Transplant Services, Intermountain Medical Center, Murray, UT, USA

    Murray, Utah, 84107, United States

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