[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Transplant Genomics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":80},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":4},"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":20,"type":21},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).",[25,26,27,28,29],"Kidney Diseases","Kidney Injury","BK Virus Infection","CMV","TTV Virus",[31,32,33,34,35,36,37],"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":41,"type":42},"2026-02-24","ACTUAL",{"date":44,"type":21},"2026-03-31",{"date":46,"type":21},"2028-10-30",{"name":48,"class":49},"Transplant Genomics, Inc.","INDUSTRY",{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":60,"conditions":61,"keywords":66,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":4},"100610726","pioneer-trial-post-transplant-application-of-trugraf-and-trac-molecular-panel-in-renal-transplant-recipients-100610726","NCT07231328","PIONEER Trial (Post-Transplant Application of TruGraf and TRAC Molecular Panel in Renal Transplant Recipients)","Post-Transplant Application of TruGraf and TRAC Molecular Panel in Renal Transplant Recipients","PIONEER","Inclusion Criteria:\n\n* Able to understand the key components of the study as described in the written informed consent document and willing and able to provide written informed consent.\n* At least 18 years of age at the time of screening.\n* Enrollment begins 30 days prior to transplant till day 29 post-transplantation.\n* Recipient of a kidney transplant (either primary or repeat), from either deceased or living donor.\n* Receiving any immunosuppressive regimen.\n* Able and willing to comply with all study procedures, as assessed by the Investigator.\n* Selected by the treating provider to undergo TruGraf and TRAC™ testing as part of routine post-transplant care\n\nExclusion Criteria:\n\nHistory of previous non-kidney solid organ, vascular composite allograft, pancreatic islet, stem cell, or bone marrow transplant.\n\n* History of dual or en-bloc kidney transplants.\n* Recipient or donor with positive test for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis B virus (HBV) nucleic acid testing (NAT), hepatitis C virus (HCV) antibody, HCV NAT, human immunodeficiency virus (HIV), or HIV NAT.\n* Patients known to be pregnant or with plans to become pregnant over the 24 months after enrollment.\n* History or presence of coagulopathy, thrombophilia, unexplained bleeding or clotting disorders, or use of or documented plans for use of systemic anticoagulants at the time of screening, with the exception of uremic coagulopathy or prophylactic heparin preparations.\n* History or presence, upon clinical evaluation, of any illness or condition that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions",{"count":59,"type":21},600,"This is an observational, prospective, multi-center trial designed to evaluate clinical outcomes in kidney transplant recipients undergoing TruGraf and TRAC monitoring.\n\nApproximately 15 U.S. sites",[62,63,64,35,65],"Immunosuppression Management","Biomarkers \u002F Blood","Subclinical Rejection","Kidney Transplant Rejection",[67,68,69,70,71],"TRAC-ID ASSAY","Kidney Transplant rejection","TruGraf, TRAC\u002FTRAC ID biomarker panel","TruGraf","TRAC","2025-11-13",{"date":74,"type":42},"2025-11-17",{"date":76,"type":21},"2025-11-20",{"date":78,"type":21},"2029-03-31",{"name":48,"class":49},""]