[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-rejection-of-renal-transplant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-rejection-of-renal-transplant":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"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":19,"type":20},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.",[24,25],"Acute Rejection of Renal Transplant","Graft Failure","RECRUITING","2025-08-06",{"date":29,"type":30},"2025-08-07","ACTUAL",{"date":32,"type":30},"2020-12-07",{"date":34,"type":20},"2026-10-01",{"name":36,"class":37},"Loma Linda University","OTHER",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":48,"targetDuration":50,"studyType":21,"phases":4,"briefSummary":51,"conditions":52,"keywords":61,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":4},"100251946","european-transplant-registry-of-senior-renal-transplant-recipients-on-advagraf-100251946","NCT02558452","European Transplant Registry of Senior Renal Transplant Recipients on Advagraf","European Transplant Registry of Senior Renal Transplant Recipients Receiving Initial Immunosuppression With Tacrolimus Once Daily, Mycophenolate and Steroids","SENIOR","Inclusion Criteria:\n\n* Males or females, aged ≥65 years\n* Patients who received a renal allograft\n* Patients who are willing and able to participate in the study and from whom written informed consent has been obtained\n* Patients on an intended standard triple therapy with tacrolimus once daily (Advagraf with trough level ≥5ng\u002Fml) in combination with mycophenolate (either ≥1.0g\u002Fday MMF or ≥720mg\u002Fd EC-MPS) and Steroids (≥5mg prednisolone or equivalent)\n* Patient must have received primary or secondary renal allograft from a blood group compatible donor (either deceased or living)\n* Patients with low to standard immunological risk, who had a PRA 20% (PRA testing according to center's practice) or no known donor specific antibodies at transplantation\n\nExclusion Criteria:\n\n* Multi-organ recipients (solid organ or bone marrow)\n* More than secondary renal allograft recipients\n* Blood group A,B,O-incompatible allografts\n* Documented presence of donor specific antibodies (DSA)\n* Panel reactive antibody (PRA) \\>20% prior to transplantation (PRA testing according to center's practice)\n* Patients having received any other induction therapy than Basiliximab or depleting polyclonal antithymocyte antibodies (ATG) (e.g. OKT3, Campath)\n* Patients receiving Sirolimus, Everolimus, Azathioprine, Belatacept or Cyclophosphamide within 3 months prior to or at enrolment\n* History of alcohol or drug abuse with less than 6 months of sobriety\n* Patient with any condition that may affect absorption of immunosuppressives, (e.g. severe diarrhoea, gastrectomy, active peptic ulcer disease or clinically significant diabetic gastroenteropathy) or tacrolimus metabolism (e.g. liver cirrhosis)\n* Patient with mental dysfunction or inability to cooperate within the study\n* Patients who have been institutionalized by official or court order","65 Years",{"count":49,"type":20},1000,"10 Years","SENIOR transplant Registry European transplant registry of senior renal transplant recipients (above the age of 65 years) receiving initial immunosuppression with tacrolimus once daily, mycophenolate and steroids to investigate long term outcomes on an observational basis.",[25,53,24,54,55,56,57,58,59,60],"Death","Infections","Bone Disease","Post Transplant Diabetes Mellitus","Quality of Life","HLA Antibody Production","Cardiovascular Risk Factors","Non-HLA Antibody Production",[62,63,64],"elderly kidney transplant recipient","registry","tacrolimus once daily","NOT_YET_RECRUITING","2016-08-11",{"date":68,"type":20},"2016-08-12",{"date":70,"type":4},"2016-12",{"date":72,"type":20},"2028-01",{"name":74,"class":37},"Klemens Budde"]