ID-ENTITY Trial- Evaluating Serial T-ID Monitoring

Starting soon

Conditions studied: Kidney Diseases, Kidney Injury, BK Virus Infection, CMV, TTV Virus

In brief

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).

Key facts

Study ID: NCT07393594
Run by: Transplant Genomics, Inc.
People needed: 1000
Starts: 2026-03-31
Expected to finish: 2028-10-30
Last updated by the study team: 2026-02-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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 participation in another investigational biomarker study designed to evaluate clinical utility of post-transplant molecular diagnostics.
Participants with asymptomatic or low-level viral replication detected during routine clinical monitoring are eligible, provided there is no evidence of established CMV disease or BK virus-associated nephropathy at enrollment.

Full record on ClinicalTrials.gov

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