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New test could slash misdiagnosis in kidney transplants

NCT ID NCT01299168

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study aims to improve how doctors diagnose problems in transplanted kidneys. Current methods rely on expert opinion, which can be wrong and lead to harmful treatments. Researchers have developed a new system that combines genetic information with standard biopsy results. They will test it on 500 to 1500 kidney transplant patients to see if it gives more accurate diagnoses.

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 more accurate and personalized diagnosis for kidney transplant patients, helping doctors choose the right treatment and avoid unnecessary harm.
What could go wrong
This is an observational study, not a treatment trial. The new system may not prove better than current methods, and results may not apply to all patients or centers.

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 500 people

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

Start date

May 2011

Expected to finish

Jun 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.

Who is studied

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

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 kidney transplant recipients ≥18yrs of age undergoing a kidney biopsy for clinical indications, as determined by their physician or surgeon, will be eligible to enrol in the study. Exclusion Criteria: * Patients will be excluded from the study if they decline participation or are unable to give informed consent.

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As listed by the trial registrant

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

Development of reporting system for molecular diagnosis Incorporate molecular diagnosis into diagnostic standards Validation study of molecular diagnostic system

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 in 3 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

    COMPLETED

    St Louis, Missouri, 63110, United States

  • Beaumont Hospital

    WITHDRAWN

    Dublin, Ireland

  • Charité - Universitätmedizin Berlin

    COMPLETED

    Berlin, Germany

  • Department of Medicine, University of Alberta

    RECRUITING

    Edmonton, Alberta, T6G 2S2, Canada

  • Department of Surgery, University of Usan, College of Medicine

    COMPLETED

    Seoul, 05505, South Korea

  • Hopital Necker

    COMPLETED

    Paris, France

  • Hopital St. Louis

    COMPLETED

    Paris, France

  • Institute for Experimental and Clinical Medicine (IKEM)

    RECRUITING

    Prague, Czechia

  • Manchester Royal Infirmary

    COMPLETED

    Manchester, M13 9WL, United Kingdom

  • Medical University of Vienna

    RECRUITING

    Vienna, Austria

  • Medizinische Hochschule

    COMPLETED

    Hanover, 30625, Germany

  • Montefiore Medical Center

    COMPLETED

    The Bronx, New York, United States

  • Pinnacle Transplant Associates

    COMPLETED

    Harrisburg, Pennsylvania, United States

  • Pomeranian Medical University in Szczecin

    COMPLETED

    Szczecin, Poland

  • Texas Transplant Institute - Methodist Healthcare System

    COMPLETED

    San Antonio, Texas, 78229, United States

  • University Hospital Merkur

    COMPLETED

    Zagreb, Croatia

  • University Hospital Zurich

    COMPLETED

    Zurich, 8091, Switzerland

  • University of Alabama

    COMPLETED

    Birmingham, Alabama, 35294-0006, United States

  • University of British Columbia, St. Paul's Hospital

    WITHDRAWN

    Vancouver, British Columbia, Canada

  • University of Ljubljana

    COMPLETED

    Ljubljana, Slovenia

  • University of Maryland School of Medicine

    COMPLETED

    Baltimore, Maryland, 21209, United States

  • University of Michigan Health System

    COMPLETED

    Ann Arbor, Michigan, 48109-5395, United States

  • University of Minnesota

    COMPLETED

    Minneapolis, Minnesota, 55455, United States

  • University of Wisconsin School of Medicine and Public Health

    COMPLETED

    Madison, Wisconsin, WI 53705, United States

  • Vall d'Hebron Hospital

    COMPLETED

    Barcelona, 08035, Spain

  • Virginia Commonwealth University School of Medicine

    COMPLETED

    Richmond, Virginia, 23298, United States