ID-ENTITY Trial- Evaluating Serial T-ID Monitoring
1,000 participantsStarted 2026-03-31
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Participants must meet all the following criteria:
* Written informed consent and HIPAA authorization obtained prior to any study-related data collection.
* Age ≥18 years at the time of enrollment.
* Recipient of a kidney transplant, including:
* Primary or repeat kidney transplantation
* Living-donor or deceased-donor transplantation
* At 1 month post-kidney transplant at the time of enrollment.
* Receiving maintenance immunosuppressive therapy per institutional standard of care.
* Selected by the treating provider to undergo TRAC testing as part of usual post-transplant clinical monitoring.
Exclusion Criteria:
* Recipient of a combined organ transplant involving a non-renal solid organ (e.g., kidney-liver, kidney-heart) and/or islet cell transplantation.
* History of prior non-renal solid organ transplantation or islet cell transplantation.
* Known pregnancy at the time of enrollment.
* Known active viral infection at enrollment with any of the following:
* Hepatitis B surface antigen (HBsAg)-positive
* Hepatitis B virus (HBV) nucleic acid testing (NAT)-positive
* Human immunodeficiency virus (HIV) infection or HIV NAT-positive
* \*Known active BK virus-associated nephropathy (BKVAN) or CMV disease at the time of enrollment.
* Medical, psychiatric, or social condition that, in the opinion of the Investigator, would interfere with the participant's ability to provide informed consent or comply with study procedures.
* Concurrent part…
What they're measuring
1
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.