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Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring
Sponsor: Insight Molecular Diagnostics
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
Conditions
Interventions
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