[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623204":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":13,"locations":7,"responsibleParty":23,"collaborators":7,"id":25,"slug":26,"hasResults":27,"nctId":28,"briefTitle":29,"officialTitle":30,"acronym":31,"eligibilityCriteria":32,"healthyVolunteers":27,"sex":33,"minAge":34,"maxAge":7,"enrollmentInfo":35,"targetDuration":7,"studyType":38,"phases":7,"briefSummary":39,"conditions":40,"keywords":46,"overallStatus":54,"whyStopped":7,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":7},{"fullName":5,"class":6},"Transplant Genomics, Inc.","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DIAGNOSTIC_TEST","Blood tests, TRAC( cell free DNA) and T-ID","Blood collection",[14,19],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"Isioma Agboli, MD","CONTACT","510 767 8609","isioma.agboli@tgi.eurofinsus.com",{"name":20,"role":16,"phone":21,"phoneExt":7,"email":22},"Bethany Barrick","619 643 1929","bethany.barrick@tgi.eurofinsus.com",{"type":24,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100623204","id-entity-trial--evaluating-serial-t-id-monitoring-100623204",false,"NCT07393594","ID-ENTITY Trial- Evaluating Serial T-ID Monitoring","A Prospective, Multicenter, Observational Study Evaluating Serial T-ID Monitoring for the Prevention of CMV Disease and BK Virus-Associated Nephropathy Following Kidney Transplantation","ID-ENTITY","Inclusion Criteria:\n\n* Participants must meet all the following criteria:\n\n  * Written informed consent and HIPAA authorization obtained prior to any study-related data collection.\n  * Age ≥18 years at the time of enrollment.\n  * Recipient of a kidney transplant, including:\n  * Primary or repeat kidney transplantation\n  * Living-donor or deceased-donor transplantation\n  * At 1 month post-kidney transplant at the time of enrollment.\n  * Receiving maintenance immunosuppressive therapy per institutional standard of care.\n  * Selected by the treating provider to undergo TRAC testing as part of usual post-transplant clinical monitoring.\n\nExclusion Criteria:\n\n* Recipient of a combined organ transplant involving a non-renal solid organ (e.g., kidney-liver, kidney-heart) and\u002For islet cell transplantation.\n* History of prior non-renal solid organ transplantation or islet cell transplantation.\n* Known pregnancy at the time of enrollment.\n* Known active viral infection at enrollment with any of the following:\n* Hepatitis B surface antigen (HBsAg)-positive\n* Hepatitis B virus (HBV) nucleic acid testing (NAT)-positive\n* Human immunodeficiency virus (HIV) infection or HIV NAT-positive\n* \\*Known active BK virus-associated nephropathy (BKVAN) or CMV disease at the time of enrollment.\n* 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.\n* Concurrent participation in another investigational biomarker study designed to evaluate clinical utility of post-transplant molecular diagnostics.\n\n  * 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.","ALL","18 Years",{"count":36,"type":37},1000,"ESTIMATED","OBSERVATIONAL","To evaluate the association between time-updated CMV and BK viral loads measured monthly by T-ID and the risk of CMV disease and\u002For 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).",[41,42,43,44,45],"Kidney Diseases","Kidney Injury","BK Virus Infection","CMV","TTV Virus",[47,48,49,50,51,52,53],"Biomarkers testing","Kidney transplant rejection","T-ID Assay","TRAC Assay cell free DNA","Biopsy","dd-cfDNA","T-ID","NOT_YET_RECRUITING","2026-02-20",{"date":57,"type":58},"2026-02-24","ACTUAL",{"date":60,"type":37},"2026-03-31",{"date":62,"type":37},"2028-10-30",{"name":5,"class":6}]