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).
* 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.
Study Type
OBSERVATIONAL
Enrollment
1,000
Blood collection
The primary endpoint of the study is the time to first occurrence of either cytomegalovirus (CMV) disease or biopsy-proven BK virus-associated nephropathy (BKVAN) during the first 12 months post-kidney transplantation.
* CMV disease will be defined according to standard clinical criteria, including CMV syndrome and/or tissue-invasive CMV disease, as determined by the treating clinician and documented in the medical record. * BK virus-associated nephropathy (BKVAN) will be defined as biopsy-proven BK virus nephropathy, characterized by histopathologic features consistent with BKVAN (including intranuclear viral inclusions and/or positive SV40 large T-antigen staining), in the setting of documented BK viral replication by standard-of-care testing (e.g., plasma or urine PCR).
Time frame: 12 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.