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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.