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Clinical Trials in Australia / NCT04239703
Recruiting Observational

Trifecta-Kidney cfDNA-MMDx Study

NCT04239703 · tracked via the Priya Life Science Australia tracker
Sponsor
University of Alberta
Phase
Observational
Started
2019-12-01
Last updated
2026-06-02

Condition(s) studied

Kidney Transplant Rejection

Investigational drug(s) / intervention(s)

MMDxProsperaHLA antibody

MMDx: Portion of kidney transplant indication biopsy

Prospera: Transplant patient blood sample

HLA antibody: Transplant patient blood sample

Study summary

Demonstrate the relationship between DD-cfDNA levels and HLA antibodies in blood, and the Molecular Microscope® (MMDx) Diagnostic System results in indication biopsies.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Calibration of Prospera test for T cell-mediated rejection — 18 months
    Calibration of DD-cfDNA test cut-off values against the probability of T cell-mediated rejection in the biopsy as reported by MMDx.
  • Calibration of Prospera test for antibody-mediated rejection — 18 months
    Calibration of DD-cfDNA test cut-off values against the probability of antibody-mediated rejection in the biopsy as reported by MMDx.
  • Calibration of Prospera test for kidney injury — 18 months
    Calibration of DD-cfDNA test cut-off values against the probability of acute and chronic kidney injury in the biopsy as reported by MMDx.
  • Report calibrated Prospera test results for rejection — 6 months
    Report new DD-cfDNA test cut-off values for rejection
  • Report calibrated Prospera test results for kidney injury — 6 month
    Report new DD-cfDNA test cut-off values for acute and chronic kidney injury

Trial sites (31)

FacilityCityRegionStatus
Tampa General Hospital Tampa Florida Recruiting
University of Maryland School of Medicine Baltimore Maryland Recruiting
The Johns Hopkins University, School of Medicine Baltimore Maryland Recruiting
Detroit Medical Center, Harper University Hospital of Wayne State University Detroit Michigan Not Yet Recruiting
Henry Ford Hospital Detroit Michigan Recruiting
Barnes-Jewish Hospital, Washington University at St. Louis St Louis Missouri Recruiting
University Hospitals Cleveland Medical Ctr. Cleveland Ohio Recruiting
Cleveland Clinic Cleveland Ohio Recruiting
Intermountain Transplant Services Murray Utah Recruiting
Virginia Commonwealth University Medical Center Richmond Virginia Recruiting
Division of Nephrology & UW Organ Transplant Center University of Washington Seattle Washington Recruiting
Department of Nephrology, The Royal Melbourne Hospital 1 South East Melbourne Australia Recruiting
University of Alberta, Department of Medicine Edmonton Alberta Recruiting
ST. Paul's Hospital, 6A Providence Building, 1081 Burrard Street Vancouver British Columbia 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
Department of Nephrology and Transplantation Medical University in Bialystok Bialystok Poland Completed
University Hospital nr1 Bydgoszcz, Klinika Transplantologii Bydgoszcz Poland Completed
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
The Children's Memorial Health Institute, Department of Nephrology, Kidney Transplantation and Hypertension Warsaw Poland Completed
Wroclaw Medical University, Department of Nephrology and Transplantation Medicine Wroclaw Poland Recruiting
Department of Nephrology, University Medical Centre Ljubljana Slovenia Recruiting
University Hospital Zurich Zurich Switzerland Completed

More University of Alberta trials in Australia

Diagnostic and Therapeutic Applications of Microarrays in Lung Transplantation Recruiting
Trifecta-Heart cfDNA-MMDx Study Recruiting
Diagnostic and Therapeutic Applications of Microarrays in Liver Transplantation Recruiting
Trifecta-Lung cfDNA-MMDx Study Recruiting
Lumbar Brace Deployment in the Emergency Department for Benign Low Back Pain Recruiting

Other trials for the same condition

A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation Recruiting
Australian Genomics Of Chronic Allograft Dysfunction Study Recruiting
Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04239703 on ClinicalTrials.gov ↗ ← All trials in Australia