New study eyes monthly virus tests to shield transplant kidneys
NCT ID NCT07393594
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study will follow 1000 kidney transplant patients for one year to see if monthly blood tests for certain viruses (CMV, BK, and TTV) can help predict and prevent serious infections and kidney damage. The goal is to learn how the body's immune system and virus levels relate to transplant outcomes, not to test a new treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 1,000 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
All subjects who meet eligibility criteria will be enrolled. As this is a non-interventional study, the protocol does not mandate any specific diagnostic, therapeutic, or management interventions. Clinical management decisions, including adjustments to immunosuppression, antiviral therapy, diagnostic testing, and biopsy decisions, remain entirely at the discretion of the treating clinicians.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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