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Clinical trial Recruiting at 3 sites Observational Ages 18 and up

Improving kidney transplant diagnosis using molecular techniques

Official title: Multi-centric Observational Study to Analyse the Diagnostic Molecular Features in the Clinical Setting of Kidney Allograft Biopsies

Run by University of Alberta · NCT01299168 · Data updated 2026-11-12

This study is testing a new way to diagnose kidney transplant issues by combining advanced lab techniques with patient information to see if it can provide more accurate results for better care.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment500 (estimated)
SponsorUniversity of Alberta
Academic / other
Locations26 sites (Birmingham, Alabama and 25 other locations)
StatusRecruiting
StartedMay 2011
Main results expectedDecember 2027
Study endsJune 2028
Registry record updatedJune 2, 2026
Trial IDNCT01299168 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are kidney transplant recipients aged 18 years and older who are undergoing a biopsy for clinical reasons.

Probably not a fit

Patients who decline participation or are unable to provide informed consent will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to validate a new diagnostic system that integrates molecular and histopathological features of kidney transplant biopsies with clinical and laboratory parameters. The Alberta Transplant Applied Genomics Centre has developed this Integrated Diagnostic System to address the limitations of the current Banff Classification, which often leads to incorrect diagnoses. The study will analyze 500 prospectively collected biopsies from various centers in North America and Europe, in addition to 300 previously collected samples. By refining this system, the study seeks to enhance the accuracy of kidney transplant diagnostics and improve patient outcomes.

Why it matters

Potential benefit: If successful, this study could lead to more accurate diagnoses and better treatment decisions for kidney transplant recipients.

How similar studies have gone: Other studies have shown promise in using molecular diagnostic approaches in organ transplantation, indicating potential for success in this novel application.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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.

Where it's running

  • Medical University of Vienna
    Vienna, Austria     Recruiting
  • Department of Medicine, University of Alberta
    Edmonton, Alberta, Canada     Recruiting
  • Institute for Experimental and Clinical Medicine (IKEM)
    Prague, Czechia     Recruiting
  • University of Alabama
    Birmingham, Alabama, United States     Completed
  • University of Maryland School of Medicine
    Baltimore, Maryland, United States     Completed
  • University of Michigan Health System
    Ann Arbor, Michigan, United States     Completed
Show 20 more locations
  • University of Minnesota
    Minneapolis, Minnesota, United States     Completed
  • Barnes-Jewish Hospital
    St Louis, Missouri, United States     Completed
  • Montefiore Medical Center
    The Bronx, New York, United States     Completed
  • Pinnacle Transplant Associates
    Harrisburg, Pennsylvania, United States     Completed
  • Texas Transplant Institute - Methodist Healthcare System
    San Antonio, Texas, United States     Completed
  • Virginia Commonwealth University School of Medicine
    Richmond, Virginia, United States     Completed
  • University of Wisconsin School of Medicine and Public Health
    Madison, Wisconsin, United States     Completed
  • University of British Columbia, St. Paul's Hospital
    Vancouver, British Columbia, Canada     Withdrawn
  • University Hospital Merkur
    Zagreb, Croatia     Completed
  • Hopital Necker
    Paris, France     Completed
  • Hopital St. Louis
    Paris, France     Completed
  • Charité - Universitätmedizin Berlin
    Berlin, Germany     Completed
  • Medizinische Hochschule
    Hanover, Germany     Completed
  • Beaumont Hospital
    Dublin, Ireland     Withdrawn
  • Pomeranian Medical University in Szczecin
    Szczecin, Poland     Completed
  • University of Ljubljana
    Ljubljana, Slovenia     Completed
  • Department of Surgery, University of Usan, College of Medicine
    Seoul, South Korea     Completed
  • Vall d'Hebron Hospital
    Barcelona, Spain     Completed
  • University Hospital Zurich
    Zurich, Switzerland     Completed
  • Manchester Royal Infirmary
    Manchester, United Kingdom     Completed

Study contacts

  • Principal investigator: Philip F Halloran, MD PhD — University of Alberta
  • Study coordinator: Philip F Halloran, MD PhD
  • Email: phallora@ualberta.ca
  • Phone: 1 780 492-6160

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.