Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring
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
| Condition(s) | Kidney Transplant Rejection, Cell-free DNA |
|---|---|
| Status | Recruiting |
| 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. |
| Who can participate | 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 b |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Insight Molecular Diagnostics |
| Locations | Los Angeles, California, United States; Jacksonville, Florida, United States; Tampa, Florida, United States; Cleveland, Ohio, United States; Pittsburgh, Pennsylvania, United States; Nashville, Tennessee, United States (+4 more sites) |
| Start date | 2025-09-08 |
| NCT ID | NCT07060716 |
| Official listing | https://clinicaltrials.gov/study/NCT07060716 |