[{"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:":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100310460","phase-2-impact-of-envarsus-xr-on-kidney-biopsy-subclinical-rejection-and-blood-immunologic-profile-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":19,"type":20},78,"ESTIMATED","INTERVENTIONAL",[23,24],"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.",[27],"End Stage Renal Disease","RECRUITING","2026-03-19",{"date":31,"type":32},"2026-03-24","ACTUAL",{"date":34,"type":32},"2019-03-28",{"date":36,"type":20},"2027-03-31",{"name":38,"class":39},"Roberto Gedaly","OTHER",""]