Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:56 AM
Study NCT ID:
NCT07393594
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ID-ENTITY Trial- Evaluating Serial T-ID Monitoring
Sponsor:
Transplant Genomics, Inc.
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ID-ENTITY
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.
* 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: