Trifecta-Kidney cfDNA-MMDx Study

Part of paid clinical trials in Tampa, Florida.

Sponsor
University of Alberta
Study ID
NCT04239703
Status
Recruiting
Apply to this trial

Conditions

  • Kidney Transplant Rejection

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • MMDx — DIAGNOSTIC_TEST
    Portion of kidney transplant indication biopsy
  • Prospera — DIAGNOSTIC_TEST
    Transplant patient blood sample
  • HLA antibody — DIAGNOSTIC_TEST
    Transplant patient blood sample

Study Details

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

Key Dates

Start date
Dec 1, 2019
Status verified
Jun 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Calibration of Prospera test for T cell-mediated rejection [ Time Frame: 18 months ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Tampa General HospitalTampaFlorida33606
Natalie Remsen
[email protected]
Rajendra Baliga, MD (PRINCIPAL_INVESTIGATOR)
The Johns Hopkins University, School of MedicineBaltimoreMaryland21205
Darin B Ostrander, PhD
[email protected]
410-614-6702
Daniel C Brennan, MD (PRINCIPAL_INVESTIGATOR)
University of Maryland School of MedicineBaltimoreMaryland21201
Raissa Toure
[email protected]
Jonathan Bromberg, MD PhD (PRINCIPAL_INVESTIGATOR)
Matt Weir, MD (PRINCIPAL_INVESTIGATOR)
Detroit Medical Center, Harper University Hospital of Wayne State UniversityDetroitMichigan48201
Rajeev Sharma, MD
[email protected]
Rajeev Sharma, MD (PRINCIPAL_INVESTIGATOR)
Mareena Zachariah, MD (SUB_INVESTIGATOR)
Henry Ford HospitalDetroitMichigan48202
Iman Francis
[email protected]
Milagros Samaniego-Picota, MD (PRINCIPAL_INVESTIGATOR)
Iman Francis, MD (SUB_INVESTIGATOR)
Anita Patel, MD (SUB_INVESTIGATOR)
Barnes-Jewish Hospital, Washington University at St. LouisSt LouisMissouri63110
Andrew Malone
[email protected]
Andrew Malone, MD PhD (PRINCIPAL_INVESTIGATOR)
Tarek Ahamad, MD (SUB_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Debra Camino
[email protected]
Emillio Poggio, MD (PRINCIPAL_INVESTIGATOR)
Richard Fatica, MD (PRINCIPAL_INVESTIGATOR)
Ziad Zaky, MD (PRINCIPAL_INVESTIGATOR)
University Hospitals Cleveland Medical Ctr.ClevelandOhio44106-5048
Katherine R Carter
[email protected]
Jittirat Arksarapuk, MD (PRINCIPAL_INVESTIGATOR)
Intermountain Transplant ServicesMurrayUtah84107
Sanjiv Anand, MD (PRINCIPAL_INVESTIGATOR)
Virginia Commonwealth University Medical CenterRichmondVirginia23298
Gaurav Gupta, MD
[email protected]
Gaurav Gupta, MD (PRINCIPAL_INVESTIGATOR)
Layla Camal, MD (PRINCIPAL_INVESTIGATOR)
Division of Nephrology & UW Organ Transplant Center University of WashingtonSeattleWashington98195
Chris Blosser, MD
[email protected]
Chris Bosser, MD (PRINCIPAL_INVESTIGATOR)

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Tampa General Hospital· Tampa, FLThe Johns Hopkins University, School of Medicine· Baltimore, MDUniversity of Maryland School of Medicine· Baltimore, MDDetroit Medical Center, Harper University Hospital of Wayne State University· Detroit, MIHenry Ford Hospital· Detroit, MIBarnes-Jewish Hospital, Washington University at St. Louis· St Louis, MO

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