[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100445771":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":50,"collaborators":10,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":10,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":10,"enrollmentInfo":61,"targetDuration":10,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":10,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Loma Linda University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Rejection of kidney transplant",null,"Diagnostic test: measurement of regulatory T cell and donor-derived cell-free DNA",[13],"Diagnostic Test: Donor-derived cell-free DNA",{"label":15,"type":10,"description":11,"interventionNames":16},"No rejection of kidney transplant",[13],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DIAGNOSTIC_TEST","Donor-derived cell-free DNA","As mentioned previously",[15,9],[24],"Regulatory T cell",[26],{"name":27,"affiliation":5,"role":28},"Minh-Tri Nguyen, MD PhD","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":10,"email":34},"Ryan Evans, CCRP","CONTACT","9095583870","rlevans@llu.edu",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":10},"Loma Linda University Health","RECRUITING","Loma Linda","California","92354","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-117.26115,34.04835,{"lat":48,"lon":47},{"type":51,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100445771","dd-cfdna-and-treg-in-prediction-of-kidney-transplant-acute-rejection-100445771",false,"NCT05084768","Dd-cfDNA and Treg in Prediction of Kidney Transplant Acute Rejection","Integration of Donor-derived Cell-free DNA With HLA-DR+TNFR2+ Regulatory T Cell in the Prediction of Acute Rejection and Graft Function After Kidney Transplantation","Inclusion Criteria:\n\n* Adult kidney transplant candidates\u002Frecipients\n\nExclusion Criteria:\n\n* Age less than 18\n* Multi-organ transplants\n* Kidney transplant candidates\u002Frecipients with HIV\n* Kidney transplant candidates\u002Frecipients with HCV","ALL","18 Years",{"count":62,"type":63},150,"ESTIMATED","OBSERVATIONAL","Acute rejection after kidney transplantation should ideally be diagnosed prior to immunologic injury in a non-invasive fashion in order to improve long-term graft function. Donor-derived cell-free DNA (ddcfDNA) is a promising method to do so as it is elevated prior to acute rejection and has good predictive performance especially for antibody-mediated and high severity T-cell mediated rejection. Its ability to predict low severity T-cell mediated rejection and future graft function remains equivocal. Regulatory T cells (Tregs) are essential in transplant tolerance by suppressing effector immune responses. Circulating post-transplant highly suppressive HLA-DR+ Tregs were reduced in recipients who developed acute rejection. Preliminary results in a cohort including predominantly low severity T-cell mediated rejection also showed that pre-transplant circulating highly suppressive TNFR2+ Tregs were reduced in and could predict acute rejection. Integrating dd-cfDNA with HLA-DR+TNFR2+ Treg could improve the predictive performance for acute rejection especially of low severity and potentially predict graft function. Plasma dd-cfDNA and HLA-DR+TNFR2+ Tregs will be measured in 150 kidney transplant recipients at scheduled intervals during the first 6 months post-transplant. Predictive accuracy of a model integrating ddcfDNA and HLA-DR+TNFR2+ Treg for acute rejection will be tested using ROC curve analysis and multivariate logistic regression. Predictive accuracy for 1-year graft function will be tested using multivariate linear regression. High predictive performance for acute rejection and graft function using a model integrating dd-cfDNA and HLA-DR+TNFR2+ Treg would help identify kidney transplant recipients at immunologic risk early on and allow personalization of immunosuppression accordingly.",[67,68],"Acute Rejection of Renal Transplant","Graft Failure","2025-08-06",{"date":71,"type":72},"2025-08-07","ACTUAL",{"date":74,"type":72},"2020-12-07",{"date":76,"type":63},"2026-10-01",{"name":5,"class":6},1]