Trials / Recruiting
RecruitingNCT07060716
Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring
GraftAssureDx Study: Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 125 (estimated)
- Sponsor
- Insight Molecular Diagnostics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | donor-derived cell-free DNA test | A donor-derived cell-free DNA (dd-cfDNA) test used to measure the concentration of total cell-free DNA and the fractional abundance of the dd-cfDNA. |
Timeline
- Start date
- 2025-09-08
- Primary completion
- 2025-11-30
- Completion
- 2025-12-01
- First posted
- 2025-07-11
- Last updated
- 2025-11-19
Locations
10 sites across 2 countries: United States, Germany
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07060716. Inclusion in this directory is not an endorsement.