[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100070528":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":41,"centralContacts":30,"locations":44,"responsibleParty":55,"collaborators":30,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":30,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":30,"enrollmentInfo":67,"targetDuration":30,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":78,"whyStopped":30,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":89},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8,16,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A: No RAD","ACTIVE_COMPARATOR","Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)\u002FAzathioprine (AZA) ± Steroids",[13,14,15],"Drug: Calcineurin Inhibitors (CNI)","Drug: Mycophenolate acid (MPA)\u002FAzathioprine (AZA)","Drug: Steroids",{"label":17,"type":18,"description":19,"interventionNames":20},"Group B : CNI Withdrawal","EXPERIMENTAL","Initiation of everolimus (8-12 ng\u002FmL) with discontinuation of CNI. Everolimus(RAD001) 4 mg initial daily dose.",[21,14,15],"Drug: Everolimus (RAD001)",{"label":23,"type":18,"description":24,"interventionNames":25},"Group C: CNI Reduction","Initiation of everolimus (3-8 ng\u002FmL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.",[21,13,14,15],[27,32,35,38],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":30},"DRUG","Everolimus (RAD001)",null,[17,23],{"type":28,"name":33,"description":30,"armGroupLabels":34,"otherNames":30},"Calcineurin Inhibitors (CNI)",[9,23],{"type":28,"name":36,"description":30,"armGroupLabels":37,"otherNames":30},"Mycophenolate acid (MPA)\u002FAzathioprine (AZA)",[9,17,23],{"type":28,"name":39,"description":30,"armGroupLabels":40,"otherNames":30},"Steroids",[9,17,23],[42],{"name":5,"affiliation":5,"role":43},"STUDY_DIRECTOR",[45],{"facility":5,"status":30,"city":46,"state":30,"zip":30,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":30},"Basel","Switzerland","CH",{"type":50,"coordinates":51},"Point",[52,53],7.57327,47.55839,{"lat":53,"lon":52},{"type":56,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100070528","phase-4-ascertain-assessment-of-everolimus-in-addition-to-calcineurin-inhibitor-reduction-in-the-maintenance-of-renal-transplant-recipients-100070528",true,"NCT00170846","ASCERTAIN: Assessment of Everolimus in Addition to Calcineurin Inhibitor Reduction in the Maintenance of Renal Transplant Recipients","Assessment of Everolimus in Addition to Calcineurin Inhibitors Reduction in Maintenance Renal Transplant Recipients","Inclusion Criteria:\n\n* Male or female patient at least 18 years of age.\n* Patient who has undergone a primary or secondary renal transplant 12-96 months ago from a living related or unrelated donor or a cadaveric donor.\n* Patient receiving cyclosporine microemulsion with a C2-h level ≥ 400 ng\u002FmL or tacrolimus with a C0-h level ≥ 4 ng\u002FmL with or without mycophenolic acid or azathioprine plus or minus steroids.\n* The immunosuppressive regimen must remain unchanged within the last 3 months.\n* Patient with renal impairment defined as GFR between 30 and 70 mL\u002Fmin\u002F1.73 m\\^2 by Cockcroft-Gault formula.\n\nExclusion Criteria:\n\n* Patient who is recipient of multiple organ transplants.\n* Patient with protein\u002Fcreatinine ratio ≥ 150 (mg\u002Fmmol).\n* Patient with a treated acute rejection episode within the last 3 months.\n* Patient with any past or present BK-polyomavirus nephropathy.\n* Patient with de novo or recurrent glomerular nephritis.\n\nOther protocol defined inclusion\u002Fexclusion criteria may apply.",false,"ALL","18 Years",{"count":68,"type":69},394,"ACTUAL","INTERVENTIONAL",[72],"PHASE4","The study is designed to evaluate whether the initiation of everolimus together with the reduction or discontinuation of calcineurin inhibitors (CNIs) will improve graft function in the maintenance of renal transplant recipients with renal impairment by reducing the progression of chronic allograft nephropathy. The development of atherosclerosis in the native arteries of the patients will also be explored.",[75],"Renal Transplantation",[77],"Renal transplantation, everolimus, calcineurin inhibitors, GFR","COMPLETED","2015-01-15",{"date":81,"type":82},"2015-01-27","ESTIMATED",{"date":84,"type":30},"2005-02",{"date":86,"type":69},"2009-10",{"name":88,"class":6},"Novartis Pharmaceuticals",1]