ID-ENTITY Trial- Evaluating Serial T-ID Monitoring
brief summary
To evaluate the association between time-updated CMV and BK viral loads measured monthly by T-ID and the risk of CMV disease and/or biopsy-proven BK virus-associated nephropathy (BKVAN) during the first 12 months following kidney transplantation, accounting for the net immune environment (TTV viral load) and allograft injury (donor-derived cell-free DNA, dd-cfDNA).
detailed description
* To characterize time-updated viral detection patterns (e.g., transient vs sustained CMV or BK signals) identified by T-ID prior to development of CMV disease or BKVAN. * To evaluate the clinical utility of T-ID monitoring, defined by the frequency and type of clinical management actions taken following test results. * To estimate the diagnostic performance of T-ID for clinically meaningful viral infection compared with standard-of-care (PCR) testing and clinical adjudication. * To quantify lead time between T-ID detection of viral cfDNA and standard-of-care confirmation or initiation of therapy. * To assess the safety of biomarker-informed management, including both rejection following infection-directed management and infection following rejection-directed management.
official title
A Prospective, Multicenter, Observational Study Evaluating Serial T-ID Monitoring for the Prevention of CMV Disease and BK Virus-Associated Nephropathy Following Kidney Transplantation