Trifecta-Kidney cfDNA-MMDx Study

NCT04239703 · tracked via the Priya Life Science Czechia 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

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)

Facility	City	Region	Status
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

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Trifecta-Lung cfDNA-MMDx Study Recruiting

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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 Czechia