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Blood test could spare kidney patients painful biopsies

NCT ID NCT04239703

Diagnosis Sponsor: University of Alberta 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether a blood test (called DD-cfDNA) can accurately detect kidney transplant rejection, potentially replacing the need for invasive kidney biopsies. Researchers will compare the blood test results with standard biopsy analysis in 300 kidney transplant recipients. If successful, this could make monitoring for rejection safer and more comfortable for 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 300 people

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

Started

Dec 2019

Expected to finish

Dec 2029

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

The study population includes patients with a functioning kidney transplant undergoing a biopsy for clinical indications as standard of care to determine the cause of their graft dysfunction (deterioration in graft function, delayed graft function, proteinuria).

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: * All kidney transplant recipients undergoing a kidney biopsy for clinical indications, as determined by their physician or surgeon, will be eligible to enroll in the study. Exclusion Criteria: * Patients will be excluded from the study if they decline participation or are unable to give informed consent or multiple organ recipients.

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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 transplant rejection

How to take part

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

  1. The places running it

    27 sites in 9 countries. 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

  • Barnes-Jewish Hospital, Washington University at St. Louis

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Centre of Nephrology, Vilnius University Hospital Santaros Klinikos

    RECRUITING

    Vilnius, LT-08661, Lithuania

  • Charite-Medical University of Berlin Department of Nephrology

    RECRUITING

    Berlin, 10117, Germany

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Department of Nephrology and Transplantation Medical University in Bialystok

    COMPLETED

    Bialystok, 15-540, Poland

  • Department of Nephrology, The Royal Melbourne Hospital 1 South East

    RECRUITING

    Melbourne, VIC 3050, Australia

  • Department of Nephrology, Transplantation and Internal Medicine, University Hospital n.2

    RECRUITING

    Szczecin, 70-111, Poland

  • Department of Nephrology, University Medical Centre

    RECRUITING

    Ljubljana, 21000, Slovenia

  • Department of Transplantation and General Surgery, Wojewodzki Hospital

    RECRUITING

    Poznan, 60-479, Poland

  • Detroit Medical Center, Harper University Hospital of Wayne State University

    NOT_YET_RECRUITING

    Detroit, Michigan, 48201, United States

  • Division of Nephrology & UW Organ Transplant Center University of Washington

    RECRUITING

    Seattle, Washington, 98195, United States

  • Henry Ford Hospital

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Institute for Clinical and Experimental Medicine (IKEM)

    RECRUITING

    Prague, 140 21 Praha 4, Czechia

  • Intermountain Transplant Services

    RECRUITING

    Murray, Utah, 84107, United States

  • Medical University of Gdańsk Klinika Nefrologii Transplantologii i Chorób Wewnętrznych

    RECRUITING

    Gdansk, 80-259, Poland

  • Medical University of Silesia

    RECRUITING

    Katowice, 40-027, Poland

  • Medical University of Warsaw, Department of Transplantation Medicine, Nephrology and Internal Diseases

    RECRUITING

    Warsaw, 02-006, Poland

  • Pomeranian Medical University, Samodzielny Publiczny Woj. Szpital Zespolony, Oddzial Nefrologii i Transplantacji Nerek

    RECRUITING

    Szczecin, 71-455, Poland

  • ST. Paul's Hospital, 6A Providence Building, 1081 Burrard Street

    RECRUITING

    Vancouver, British Columbia, V6Z 1Y6, Canada

  • Tampa General Hospital

    RECRUITING

    Tampa, Florida, 33606, United States

  • The Children's Memorial Health Institute, Department of Nephrology, Kidney Transplantation and Hypertension

    COMPLETED

    Warsaw, 04-730, Poland

  • The Johns Hopkins University, School of Medicine

    RECRUITING

    Baltimore, Maryland, 21205, United States

  • Transplant Medicine & Nephrology Clinic, Medical University of Warsaw

    RECRUITING

    Warsaw, 02-006, Poland

  • University Hospital Merkur Renal Division

    RECRUITING

    Zagreb, 1910000, Croatia

  • University Hospital Zurich

    COMPLETED

    Zurich, 8091, Switzerland

  • University Hospital nr1 Bydgoszcz, Klinika Transplantologii

    COMPLETED

    Bydgoszcz, 85-094, Poland

  • University Hospitals Cleveland Medical Ctr.

    RECRUITING

    Cleveland, Ohio, 44106-5048, United States

  • University of Alberta, Department of Medicine

    RECRUITING

    Edmonton, Alberta, T6G 2G3, Canada

  • University of Maryland School of Medicine

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • Virginia Commonwealth University Medical Center

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Wroclaw Medical University, Department of Nephrology and Transplantation Medicine

    RECRUITING

    Wroclaw, 50-556, Poland

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