GraftAssureDx Study: Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Subject is 18 years of age or older
• At least 12 calendar days have elapsed since the subject received a kidney transplant.
• Subject has provided legally effective informed consent
• Subject agrees to comply with all study procedures
Locations
United States
California
University of Southern California Keck School of Medicine
ACTIVE_NOT_RECRUITING
Los Angeles
Florida
Mayo Clinic in Florida
ACTIVE_NOT_RECRUITING
Jacksonville
Tampa General Hospital
RECRUITING
Tampa
Ohio
Cleveland Clinic
ACTIVE_NOT_RECRUITING
Cleveland
Pennsylvania
University of Pittsburgh Medical Center
ACTIVE_NOT_RECRUITING
Pittsburgh
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
Baylor, Scott & White Research Institute
ACTIVE_NOT_RECRUITING
Dallas
Utah
Intermountain Health
RECRUITING
Murray
Other Locations
Germany
Charite Universitatsmedizin
ACTIVE_NOT_RECRUITING
Berlin
Institute of Immunology - Transplantation Immunology
ACTIVE_NOT_RECRUITING
Heidelberg
Contact Information
Primary
Robert Rogers, M.S.
rrogers@imdxinc.com
14436258427
Backup
Ekkehard Schuetz, MD, PhD
eschuetz@imdxinc.com
615-927-1528
Time Frame
Start Date: 2025-09-08
Estimated Completion Date: 2025-12
Participants
Target number of participants: 125
Related Therapeutic Areas
Sponsors
Leads: Insight Molecular Diagnostics