NCT07393594

ID-ENTITY Trial- Evaluating Serial T-ID Monitoring

A Prospective, Multicenter, Observational Study Evaluating Serial T-ID Monitoring for the Prevention of CMV Disease and BK Virus-Associated Nephropathy Following Kidney Transplantation

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Transplant Genomics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Diseases
• Kidney Injury
• BK Virus Infection
• CMV
• TTV Virus

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood tests, TRAC( cell free DNA) and T-ID	Blood collection

Timeline

• Start date: 2026-03-31
• Primary completion: 2028-04-30
• Completion: 2028-10-30
• First posted: 2026-02-06
• Last updated: 2026-02-24