Clinical trial Recruiting at 26 sites Observational

Monitoring kidney transplant rejection using blood tests

Official title: Trifecta-Kidney cfDNA-MMDx Study: Comparing the DD-cfDNA Test to MMDx Microarray Test, Central HLA Antibody Test, and Histology.

Run by University of Alberta · NCT04239703 · Data updated 2026-11-12

This study is testing if measuring certain DNA levels in the blood can help doctors better detect kidney transplant rejection in patients who are already having biopsies.

Quick facts

Study typeObservational
SexAll
Enrollment300 (estimated)
SponsorUniversity of Alberta
Academic / other
Locations31 sites (Tampa, Florida and 30 other locations)
StatusRecruiting
StartedDecember 1, 2019
Main results expectedDecember 2028
Study endsDecember 2029
Registry record updatedJune 2, 2026
Trial IDNCT04239703 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are kidney transplant recipients who are undergoing a biopsy for clinical indications.

Probably not a fit

Patients who decline participation, are unable to give informed consent, or are multiple organ recipients may 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 observational study aims to explore the relationship between donor-derived cell-free DNA (DD-cfDNA) levels and HLA antibodies in the blood of kidney transplant recipients. It seeks to improve the detection of kidney transplant rejection by utilizing the Molecular Microscope® Diagnostic System (MMDx) alongside the Prospera® test, which quantifies DD-cfDNA through advanced sequencing techniques. The study will involve kidney transplant patients who are undergoing biopsies for clinical reasons, allowing for a comprehensive assessment of rejection and injury. By comparing traditional methods with molecular diagnostics, the study hopes to enhance the accuracy of rejection detection.

Why it matters

Potential benefit: If successful, this study could lead to more accurate and timely detection of kidney transplant rejection, improving patient outcomes.

How similar studies have gone: Other studies have shown promise in using molecular diagnostics for transplant rejection, indicating that this approach may be effective.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Tampa General Hospital
    Tampa, Florida, United States
    Recruiting
  • University of Maryland School of Medicine
    Baltimore, Maryland, United States
    Recruiting
  • The Johns Hopkins University, School of Medicine
    Baltimore, Maryland, United States
    Recruiting
  • Henry Ford Hospital
    Detroit, Michigan, United States
    Recruiting
  • Barnes-Jewish Hospital, Washington University at St. Louis
    St Louis, Missouri, United States
    Recruiting
  • University Hospitals Cleveland Medical Ctr.
    Cleveland, Ohio, United States
    Recruiting
Show 25 more locations
  • Cleveland Clinic
    Cleveland, Ohio, United States
    Recruiting
  • Intermountain Transplant Services
    Murray, Utah, United States
    Recruiting
  • Virginia Commonwealth University Medical Center
    Richmond, Virginia, United States
    Recruiting
  • Division of Nephrology & UW Organ Transplant Center University of Washington
    Seattle, Washington, United States
    Recruiting
  • Department of Nephrology, The Royal Melbourne Hospital 1 South East
    Melbourne, Australia
    Recruiting
  • University of Alberta, Department of Medicine
    Edmonton, Alberta, Canada
    Recruiting
  • ST. Paul's Hospital, 6A Providence Building, 1081 Burrard Street
    Vancouver, British Columbia, Canada
    Recruiting
  • University Hospital Merkur Renal Division
    Zagreb, Croatia
    Recruiting
  • Institute for Clinical and Experimental Medicine (IKEM)
    Prague, Czechia
    Recruiting
  • Charite-Medical University of Berlin Department of Nephrology
    Berlin, Germany
    Recruiting
  • Centre of Nephrology, Vilnius University Hospital Santaros Klinikos
    Vilnius, Lithuania
    Recruiting
  • Medical University of Gdańsk Klinika Nefrologii Transplantologii i Chorób Wewnętrznych
    Gdansk, Poland
    Recruiting
  • Medical University of Silesia
    Katowice, Poland
    Recruiting
  • Department of Transplantation and General Surgery, Wojewodzki Hospital
    Poznan, Poland
    Recruiting
  • Department of Nephrology, Transplantation and Internal Medicine, University Hospital n.2
    Szczecin, Poland
    Recruiting
  • Pomeranian Medical University, Samodzielny Publiczny Woj. Szpital Zespolony, Oddzial Nefrologii i Transplantacji Nerek
    Szczecin, Poland
    Recruiting
  • Medical University of Warsaw, Department of Transplantation Medicine, Nephrology and Internal Diseases
    Warsaw, Poland
    Recruiting
  • Transplant Medicine & Nephrology Clinic, Medical University of Warsaw
    Warsaw, Poland
    Recruiting
  • Wroclaw Medical University, Department of Nephrology and Transplantation Medicine
    Wroclaw, Poland
    Recruiting
  • Department of Nephrology, University Medical Centre
    Ljubljana, Slovenia
    Recruiting
  • Detroit Medical Center, Harper University Hospital of Wayne State University
    Detroit, Michigan, United States
    Not yet recruiting
  • Department of Nephrology and Transplantation Medical University in Bialystok
    Bialystok, Poland
    Completed
  • University Hospital nr1 Bydgoszcz, Klinika Transplantologii
    Bydgoszcz, Poland
    Completed
  • The Children's Memorial Health Institute, Department of Nephrology, Kidney Transplantation and Hypertension
    Warsaw, Poland
    Completed
  • University Hospital Zurich
    Zurich, Switzerland
    Completed

Study contacts

  • Principal investigator: Philip F Halloran, MD, PhD — University of Alberta
  • Study coordinator: Konrad S Famulski, PhD
  • Email: konrad@ualberta.ca
  • Phone: 1 780 492 1725

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.
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.