Clinical Trial

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

Recruiting
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Record status
This record was last updated November 19, 2025 (before its estimated November 30, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2025-07-01; most recent amendment 2025-11-18.
Status change: Not Yet Recruiting → Recruiting 2025-07-18
Trial Details
NCT Number NCT07060716
Lead Sponsor Insight Molecular Diagnostics
Conditions Kidney Transplant Rejection, Cell-free DNA
Enrollment 125 participants
Start Date 2025-09-08
Primary Completion 2025-11-30 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-11-19