RecruitingNCT04239703

Trifecta-Kidney cfDNA-MMDx Study

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

Sponsor

University of Alberta

Enrollment

300 participants

Start Date

Dec 1, 2019

Study Type

OBSERVATIONAL

Conditions

Kidney Transplant Rejection

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

Inclusion Criteria1

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 Criteria1

Patients will be excluded from the study if they decline participation or are unable to give informed consent or multiple organ recipients.

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Interventions

DIAGNOSTIC_TESTMMDx

Portion of kidney transplant indication biopsy

DIAGNOSTIC_TESTProspera

Transplant patient blood sample

DIAGNOSTIC_TESTHLA antibody

Transplant patient blood sample

Locations(31)

Tampa General Hospital

Tampa, Florida, United States

University of Maryland School of Medicine

Baltimore, Maryland, United States

The Johns Hopkins University, School of Medicine

Baltimore, Maryland, United States

Detroit Medical Center, Harper University Hospital of Wayne State University

Detroit, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Barnes-Jewish Hospital, Washington University at St. Louis

St Louis, Missouri, United States

University Hospitals Cleveland Medical Ctr.

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Intermountain Transplant Services

Murray, Utah, United States

Virginia Commonwealth University Medical Center

Richmond, Virginia, United States

Division of Nephrology & UW Organ Transplant Center University of Washington

Seattle, Washington, United States

Department of Nephrology, The Royal Melbourne Hospital 1 South East

Melbourne, Australia

University of Alberta, Department of Medicine

Edmonton, Alberta, Canada

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

Vancouver, British Columbia, Canada

University Hospital Merkur Renal Division

Zagreb, Croatia

Institute for Clinical and Experimental Medicine (IKEM)

Prague, Czechia

Charite-Medical University of Berlin Department of Nephrology

Berlin, Germany

Centre of Nephrology, Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania

Department of Nephrology and Transplantation Medical University in Bialystok

Bialystok, Poland

University Hospital nr1 Bydgoszcz, Klinika Transplantologii

Bydgoszcz, Poland

Medical University of Gdańsk Klinika Nefrologii Transplantologii i Chorób Wewnętrznych

Gdansk, Poland

Medical University of Silesia

Katowice, Poland

Department of Transplantation and General Surgery, Wojewodzki Hospital

Poznan, Poland

Department of Nephrology, Transplantation and Internal Medicine, University Hospital n.2

Szczecin, Poland

Pomeranian Medical University, Samodzielny Publiczny Woj. Szpital Zespolony, Oddzial Nefrologii i Transplantacji Nerek

Szczecin, Poland

Medical University of Warsaw, Department of Transplantation Medicine, Nephrology and Internal Diseases

Warsaw, Poland

Transplant Medicine & Nephrology Clinic, Medical University of Warsaw

Warsaw, Poland

The Children's Memorial Health Institute, Department of Nephrology, Kidney Transplantation and Hypertension

Warsaw, Poland

Wroclaw Medical University, Department of Nephrology and Transplantation Medicine

Wroclaw, Poland

Department of Nephrology, University Medical Centre

Ljubljana, Slovenia

University Hospital Zurich

Zurich, Switzerland

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