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
🩺 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: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (12 items).
Location: University of Southern California Keck School of Medicine — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
- donor-derived cell-free DNA test (DIAGNOSTIC_TEST)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Kidney donor is an identical twin of the subject.
- The subject has another previously transplanted organ in situ.
- Subject has received a hematopoietic stem cell transplant.
- Subject has received a bone marrow graft.
- Subject has self-reported as pregnant.
- In the opinion of the investigator, the subject's participation in the study would pose a risk to data integrity or to the subject's safety and welfare. Sample Inclusion Criteria: 1\. A graft biopsy is obtained within ±1 week of blood draw.
- If blood draw is obtained after biopsy, blood draw should be taken at least 2 days after an uncomplicated biopsy procedure. Sample Exclusion Criteria:
- Sample collected from someone that had an invasive graft biopsy ≤ 48 hours prior to blood draw.
- Sample collected from subject that received immunosuppressive treatment for biopsy-proven acute rejection ≤ 30 days prior to blood draw
- Sample collected from subject that received a blood transfusion ≤ 30 days prior to blood draw.
- Sample collected from a subject that provided another sample for the study within the past 7 days.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (10 Sites)
- University of Southern California Keck School of Medicine — Los Angeles, California
- Mayo Clinic in Florida — Jacksonville, Florida
- Tampa General Hospital — Tampa, Florida
- Cleveland Clinic — Cleveland, Ohio
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania
- Vanderbilt University Medical Center — Nashville, Tennessee
- Baylor, Scott & White Research Institute — Dallas, Texas
- Intermountain Health — Murray, Utah
- Institute of Immunology - Transplantation Immunology — Heidelberg, Baden-Wurttemberg
- Charite Universitatsmedizin — Berlin,
📞 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.
💰 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 § 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.
More studies in Kidney Transplant Rejection
- Microbiome and Immunosuppression: The Mission Study — Minneapolis, Minnesota
- Trifecta-Kidney cfDNA-MMDx Study — Tampa, Florida
- Validation of Genomic Immune-phenotyping Profiles to Predict Risk of Kidney Transplant Rejection — Chicago, Illinois
- The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive) — Birmingham, Alabama
- Treatment of Antibody-Mediated Rejection (ABMR) With CarBel — Birmingham, Alabama
Explore by condition: All Kidney Transplant Rejection clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.