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Enrolling by invitation Observational

ID-ENTITY Trial- Evaluating Serial T-ID Monitoring

NCT07393594 · tracked via the Priya Life Science USA tracker
Sponsor
Transplant Genomics, Inc
Phase
Observational
Started
2026-05-19
Last updated
2026-10-06

Condition(s) studied

Kidney DiseasesKidney InjuryBK Virus InfectionCMVTTV Virus

Investigational drug(s) / intervention(s)

Blood tests, TRAC( cell free DNA) and T-ID

Blood tests, TRAC( cell free DNA) and T-ID: Blood collection

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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. — 12 Months
    * CMV disease will be defined according to standard clinical criteria, including CMV syndrome and/or tissue-invasive CMV disease, as determined by the treating clinician and documented in the medical record. * BK virus-associated nephropathy (BKVAN) will be defined as biopsy-proven BK virus nephropathy, characterized by histopathologic features consistent with BKVAN (including intranuclear viral inclusions and/or positive SV40 large T-antigen staining), in the setting of documented BK viral replication by standard-of-care testing (e.g., plasma or urine PCR).

Trial sites (14)

FacilityCityRegionStatus
Mayo Clinic Arizona Phoenix Arizona
Keck Hospital of USC Los Angeles California
UCLA Los Angeles California
University of Kansas Medical Center Kansas City Kansas
Henry Ford Health Detroit Michigan
Dartmouth Lebanon New Hampshire
Cooperman Barnabas Medical Center Livingston New Jersey
Erie County Medical Center Buffalo New York
Eastern Carolina University, Brody School of Medicine Greenville North Carolina
Atrium Health Wake Forest Baptist Winston-Salem North Carolina
Medical University of South Carolina Charleston South Carolina
Dallas Renal Group Dallas Texas
Intermountain Health Murray Utah
Inova Fairfax Hospital Falls Church Virginia
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07393594 on ClinicalTrials.gov ↗ ← All trials in the USA