Recruiting

cfDNA-MMDx

Sponsor:

University of Alberta

Code:

NCT04239703

Conditions

Kidney Transplant Rejection

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

MMDx

Prospera

HLA antibody

Study Details

Brief summary:

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

Conditions

Kidney Transplant Rejection

Study ID

NCT04239703

Start date

Dec 1, 2019

Status verified date

Jun, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Kidney transplant biopsies for cause

The study population includes patients with a functioning kidney transplant undergoing a biopsy for clinical indications as standard of care.

Interventions

MMDx

Portion of kidney transplant indication biopsy

Prospera

Transplant patient blood sample

HLA antibody

Transplant patient blood sample

Primary outcome measure

  • Calibration of Prospera test for T cell-mediated rejection [ Time Frame: 18 months ]
  • Calibration of Prospera test for antibody-mediated rejection [ Time Frame: 18 months ]
  • Calibration of Prospera test for kidney injury [ Time Frame: 18 months ]
  • Report calibrated Prospera test results for rejection [ Time Frame: 6 months ]
  • Report calibrated Prospera test results for kidney injury [ Time Frame: 6 month ]

Central Contacts and Locations

Central contacts

Konrad S Famulski, PhD

1 780 492 1725konrad@ualberta.ca

Robert Polakowski, PhD

1 780 492 5091polakows@ualberta.ca

Locations

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

Contacts

Natalie Remsen

nremsen@tgh.org

Principal Investigator:

Rajendra Baliga, MD

University of Maryland School of Medicine

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Raissa Toure

RToure@som.umaryland.edu

Principal Investigator:

Jonathan Bromberg, MD PhD

The Johns Hopkins University, School of Medicine

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Darin B Ostrander, PhD

410-614-6702dostran1@jhmi.edu

Principal Investigator:

Daniel C Brennan, MD

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Iman Francis

Ifranci1@hfhs.org

Principal Investigator:

Milagros Samaniego-Picota, MD

Barnes-Jewish Hospital, Washington University at St. Louis

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Andrew Malone

amalone@wustl.edu

Principal Investigator:

Andrew Malone, MD PhD

University Hospitals Cleveland Medical Ctr.

Recruiting

Cleveland, Ohio, United States, 44106-5048

Contacts

Katherine R Carter

Katherine.carter@uhhospitals.org

Principal Investigator:

Jittirat Arksarapuk, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Debra Camino

caminod@ccf.org

Principal Investigator:

Emillio Poggio, MD

Intermountain Transplant Services

Recruiting

Murray, Utah, United States, 84107

Contacts

Jake Krong

Jake.Krong@imail.org

Principal Investigator:

Sanjiv Anand, MD

Virginia Commonwealth University Medical Center

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Gaurav Gupta, MD

ggupta@mcvh-vcu.edu

Principal Investigator:

Gaurav Gupta, MD

Division of Nephrology & UW Organ Transplant Center University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Chris Blosser, MD

CBlosser@nephrology.washington.edu

Principal Investigator:

Chris Bosser, MD

University of Alberta, Department of Medicine

Recruiting

Edmonton, Alberta, Canada, T6G 2G3

Contacts

Soroush Shojai, MD

shojai@ualberta.ca

Principal Investigator:

Soroush Shojai, MD

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

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Contacts

Angela Ogniben

AOgniben@providencehealth.bc.ca

Principal Investigator:

John S Gill, MD, MS

More Information

Sponsor

University of Alberta

Last update posted

Jun 2, 2026

Last verified

Jun, 2026

Keywords

  • donor derived cell-free DNA
  • blood
  • kidney biopsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-06-02.