[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100310460":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":32,"locations":38,"responsibleParty":59,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":25,"eligibilityCriteria":72,"healthyVolunteers":69,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":25,"studyType":79,"phases":80,"briefSummary":83,"conditions":84,"keywords":25,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"University of Kentucky","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tacrolimus","ACTIVE_COMPARATOR","0.1 - 0.2 mg\u002Fkg\u002Fday in 2 divided doses every 12 hours orally",[13],"Drug: Tacrolimus",{"label":15,"type":16,"description":17,"interventionNames":18},"Envarsus XR","EXPERIMENTAL","0.07-0.14 mg\u002Fkg\u002Fday every morning orally",[19],"Drug: Envarsus XR",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","0.1-0.2 mg\u002Fkg\u002Fday orally divided into two doses every 12 hours orally",[9],null,{"type":22,"name":15,"description":17,"armGroupLabels":27,"otherNames":25},[15],[29],{"name":30,"affiliation":5,"role":31},"Roberto Gedaly, MD","PRINCIPAL_INVESTIGATOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":25,"email":37},"Deepa Valvi, DrPH","CONTACT","8592579443","deepa.valvi@uky.edu",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Deepa Valvi","RECRUITING","Lexington","Kentucky","40536","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-84.47772,37.98869,{"lat":51,"lon":50},[54,55,56],{"name":34,"role":35,"phone":36,"phoneExt":25,"email":37},{"name":30,"role":31,"phone":25,"phoneExt":25,"email":25},{"name":57,"role":58,"phone":25,"phoneExt":25,"email":25},"TrisAnn Rendulic, PharmD","SUB_INVESTIGATOR",{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Roberto Gedaly","Sponsor\u002FInvestigator",[64],{"name":65,"class":66},"Veloxis Pharmaceuticals","INDUSTRY","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":77,"type":78},78,"ESTIMATED","INTERVENTIONAL",[81,82],"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.",[85],"End Stage Renal Disease","2026-03-19",{"date":88,"type":89},"2026-03-24","ACTUAL",{"date":91,"type":89},"2019-03-28",{"date":93,"type":78},"2027-03-31",{"name":61,"class":6},1]