[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Roberto Gedaly\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":39},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":12,"acronym":4,"eligibilityCriteria":13,"healthyVolunteers":10,"sex":14,"minAge":15,"maxAge":16,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":5},"100310460",false,"NCT03321656","Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile","Inclusion Criteria:\n\n* Fluent in English able to understand and provide informed consent.\n* End stage renal disease listed for primary solitary kidney transplant.\n* Willing to participate in the study and comply with study requirements as evidenced by signed IRB-approved informed consent.\n* Female who are of childbearing potential will be asked to use 2 different medically acceptable methods of contraception for the duration of the study and at least 1 year post-infusion.\n\nExclusion Criteria:\n\n* Previously undergone organ, tissue or cell transplant\n* Allergic to Tacrolimus or MMF (Cellcept)\n* Chronic use of blood thinners\n* Previous chronic use of glucocorticoids or other immunosuppression, or biologic immunomodulators (prescribed for the treatment of serious inflammatory disorders)\n* Significant or active infection\n* Diagnosed with HIV, Hepatitis B or C, Herpes simplex virus, Varicella-Zoster virus, Epstein-Barr virus\n* Have or have had cancer with in the past 3 years\n* Have taken part in another study that involved an investigational drug within the last 12 months.\n* Have a history of delayed or abnormal wound healing\n* Are pregnant or breastfeeding\n* Had a transfusion within the past 3 months\n* Have or plan to be receive a live vaccination (intranasal influenza measles, mumps, rubella, oral polio, yellow fever, varicella)\n* Are unable or unwilling to comply with study protocol or procedures.\n* Current use anticoagulation medication","ALL","18 Years","75 Years",{"count":18,"type":19},78,"ESTIMATED","INTERVENTIONAL",[22,23],"PHASE2","PHASE3","This will be a single center, prospective, open-label, randomized, controlled trial comparing Envarsus XR® to twice-daily tacrolimus. The targeted population will be patients with end stage renal disease listed for primary solitary kidney transplant. Transplant Surgery is not part of the study.",[26],"End Stage Renal Disease","RECRUITING","2026-03-19",{"date":30,"type":31},"2026-03-24","ACTUAL",{"date":33,"type":31},"2019-03-28",{"date":35,"type":19},"2027-03-31",{"name":37,"class":38},"Roberto Gedaly","OTHER",""]