๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-11-18

Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring (NCT07060716)

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

๐ŸŸข Recruiting Interventional Protocol ๐Ÿ“Š Observational Clinical Research Sponsor: Insight Molecular Diagnostics

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: University of Southern California Keck School of Medicine โ€” Los Angeles, California

Age range: 18 Years

๐Ÿงช Interventions in This Study

  • donor-derived cell-free DNA test (DIAGNOSTIC_TEST)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (10 Sites)

  • University of Southern California Keck School of Medicine โ€” Los Angeles, California
  • Mayo Clinic in Florida โ€” Jacksonville, Florida
  • Tampa General Hospital โ€” Tampa, Florida
  • Cleveland Clinic โ€” Cleveland, Ohio
  • University of Pittsburgh Medical Center โ€” Pittsburgh, Pennsylvania
  • Vanderbilt University Medical Center โ€” Nashville, Tennessee
  • Baylor, Scott & White Research Institute โ€” Dallas, Texas
  • Intermountain Health โ€” Murray, Utah
  • Institute of Immunology - Transplantation Immunology โ€” Heidelberg, Baden-Wurttemberg
  • Charite Universitatsmedizin โ€” Berlin,

๐Ÿ“ž Contact the Study Coordinator

Phone: (443) 625-8427

Email: rrogers@imdxinc.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—