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NCT07060716Recruiting

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

Insight Molecular Diagnostics

Start Date

9/8/2025

Completion Date

12/1/2025

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Subject is 18 years of age or older 2. At least 12 calendar days have elapsed since the subject received a kidney transplant. 3. Subject has provided legally effective informed consent 4. Subject agrees to comply with all study procedures Exclusion Criteria: 1. Kidney donor is an identical twin of the subject. 2. The subject has another previously transplanted organ in situ. 3. Subject has received a hematopoietic stem cell transplant. 4. Subject has received a bone marrow graft. 5. Subject has self-reported as pregnant. 6. 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: 1. Sample collected from someone that had an invasive graft biopsy ≤ 48 hours prior to blood draw. 2. Sample collected from subject that received immunosuppressive treatment for biopsy-proven acute rejection ≤ 30 days prior to blood draw 3. Sample collected from subject that received a blood transfusion ≤ 30 days prior to blood draw. 4. Sample collected from a subject that provided another sample for the study within the past 7 days.

Interventions

DIAGNOSTIC_TEST

donor-derived cell-free DNA test

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Conditions

Kidney Transplant RejectionCell-free DNA

Locations

University of Southern California Keck School of Medicine

Los Angeles, California 90033

United States

Mayo Clinic in Florida

Jacksonville, Florida 32224

United States

Tampa General Hospital

Tampa, Florida 33606

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania 15213

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

Baylor, Scott & White Research Institute

Dallas, Texas 75246

United States

Intermountain Health

Murray, Utah 84107

United States

Institute of Immunology - Transplantation Immunology

Heidelberg, Baden-Wurttemberg 69120

Germany

Charite Universitatsmedizin

Berlin, 10117

Germany