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RECRUITING
NCT07060716

Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring

Sponsor: Insight Molecular Diagnostics

View on ClinicalTrials.gov

Summary

The goal of this observational study is to learn if the donor-derived cell-free DNA (dd-cfDNA) test can assess rejection in kidney transplant recipients. Participants will have blood and urine collected at their study visit. Researchers will compare results of the GraftAssureDx to rejection detected by standard-of-care graft biopsies.

Official title: GraftAssureDx Study: Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

125

Start Date

2025-09-08

Completion Date

2025-12

Last Updated

2025-11-19

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

donor-derived cell-free DNA test

A donor-derived cell-free DNA (dd-cfDNA) test used to measure the concentration of total cell-free DNA and the fractional abundance of the dd-cfDNA.

Locations (10)

University of Southern California Keck School of Medicine

Los Angeles, California, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

Cleveland Clinic

Cleveland, Ohio, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Baylor, Scott & White Research Institute

Dallas, Texas, United States

Intermountain Health

Murray, Utah, United States

Institute of Immunology - Transplantation Immunology

Heidelberg, Baden-Wurttemberg, Germany

Charite Universitatsmedizin

Berlin, Germany