This is an observational, prospective, multi-center trial designed to evaluate clinical outcomes in kidney transplant recipients undergoing TruGraf and TRAC monitoring. Approximately 15 U.S. sites
All subjects who meet the inclusion criteria and none of the exclusion criteria will be eligible to participate. As the study is non-interventional, no protocol-mandated treatment or management plan will be imposed. In the absence of a universally ac-cepted paradigm for post-transplant monitoring with molecular diagnostics, participat-ing sites will be encouraged to follow their usual practice, supplemented where ap-propriate by the suggested TruGraf and TRAC™ algorithms. To evaluate both the prognostic performance and the clinical utility of these bi-omarkers, a hybrid analytic framework will be used. Biomarker results will be made available to clinicians in real time, and investigators will prospectively record whether each result led to a change in clinical management. Natural History Subgroup: Test-ing events in which both TruGraf® and TRAC results are double-negative and no change in management occurred. Analyses will be anchored at the test-event level to avoid immortal time bias. This subgroup will be used to evaluate the safety and true negative predictive value (NPV) of a double-negative result, including the incidence of biopsy-proven acute rejection (BPAR) within 30 days. • Real-World Use Subgroup: Testing events in which biomarker results prompt-ed a change in clinical management (e.g., change in immunosuppression, for-cause biopsy, or enhanced monitoring). By definition, any action following a test result places the event in this subgroup, irrespective of whether the bi-omarker result was double-negative or abnormal. Because clinical actions can alter subsequent risk trajectories, analyses in this subgroup will account for treatment-confounder feedback using causal modeling strategies (e.g., marginal structural models, target trial emulation).
Study Type
OBSERVATIONAL
Enrollment
600
Investigators will prospectively record whether each results led to a change in clinical management. Participating sites will be encouraged to follow their usual practice, supplemented where appropriate by the suggested TruGraf and TRAC™ TRAC ID algorithms
To evaluate post-transplant clinical outcomes in recipients of kidney transplants who are undergoing TruGraf and TRAC™ monitoring
The primary endpoint is a composite at 24-months post-transplant, defined as the occurrence of any of the following events: • Biopsy-proven acute rejection (BPAR) on any for-cause biopsy between Month 1 to Month 24 (local read). OR • De novo Class I or Class II DSA detected at Month 12 or Month 24 (centrally read). OR • Decline in eGFR ≥20% from Month 3 to Month 24, calculated using the CKD-EPI creatinine-based equation. OR • Three or more abnormal TruGraf and TRAC results between Months 1 and 24
Time frame: 24 Months post transplant
To evaluate the overall safety of TruGraf and TRAC monitoring in post-transplant recipients of kidney transplants.
Actions taken based on tests results TruGraf, TRAC/TRAC-ID
Time frame: Month 3 to Mo 24 post transplant
To asses the safety of a double negative TruGraf/TRAC result
Quantifying the incidence of biopsy -proven acute rejection (BPAR) withing 30 days among patients for whom no change in clinical management was undertaken
Time frame: Month 3 to Mo 24 post transplant
To explore the impact of biomarker -informed clinical decision-making on outcomes such as BPAR, estimated glomerular filtration rate (eGFR) trajectory, and immunosuppressive adjustments
Quantifying the incidence of biopsy -proven acute rejection (BPAR) withing 30 days among patients for whom no change in clinical management was undertaken
Time frame: Month 3 to Mo 24 post transplant
Isioma Agboli, Assistant Director, Clinical Programs, MD
CONTACT
Iulia Movileanu, Senior Clinical Trial Manager, MS CCRP
CONTACT
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