ID-ENTITY Trial- Evaluating Serial T-ID Monitoring
Condition(s) studied
Investigational drug(s) / intervention(s)
Blood tests, TRAC( cell free DNA) and T-ID: Blood collection
Study 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).
Eligibility
Primary outcome measure(s)
- 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. — 12 Months
* 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).
Trial sites (14)
| Facility | City | Region | Status |
|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | |
| Keck Hospital of USC | Los Angeles | California | |
| UCLA | Los Angeles | California | |
| University of Kansas Medical Center | Kansas City | Kansas | |
| Henry Ford Health | Detroit | Michigan | |
| Dartmouth | Lebanon | New Hampshire | |
| Cooperman Barnabas Medical Center | Livingston | New Jersey | |
| Erie County Medical Center | Buffalo | New York | |
| Eastern Carolina University, Brody School of Medicine | Greenville | North Carolina | |
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | |
| Medical University of South Carolina | Charleston | South Carolina | |
| Dallas Renal Group | Dallas | Texas | |
| Intermountain Health | Murray | Utah | |
| Inova Fairfax Hospital | Falls Church | Virginia |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07393594 on ClinicalTrials.gov ↗ ← All trials in the USA