[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100261749":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":55,"centralContacts":59,"locations":60,"responsibleParty":194,"collaborators":59,"id":196,"slug":197,"hasResults":198,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":59,"eligibilityCriteria":202,"healthyVolunteers":198,"sex":203,"minAge":204,"maxAge":205,"enrollmentInfo":206,"targetDuration":59,"studyType":209,"phases":210,"briefSummary":212,"conditions":213,"keywords":59,"overallStatus":215,"whyStopped":59,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":225},{"fullName":5,"class":6},"Hoffmann-La Roche","INDUSTRY",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Mycophenolate Mofetil + Cyclosporine","ACTIVE_COMPARATOR","Participants will receive mycophenoate mofetil, daclizumab, cyclosporine, and corticosteroids (prednisolone) for 3 to 12 months.",[13,14,15,16],"Drug: Cyclosporine","Drug: Daclizumab","Drug: Mycophenoate Mofetil","Drug: Prednisolone",{"label":18,"type":19,"description":20,"interventionNames":21},"Mycophenolate Mofetil + Sirolimus","EXPERIMENTAL","Participants will receive mycophenoate mofetil, daclizumab, and corticosteroids (prednisolone) for 3 to 12 months. Participants will also receive cyclosporine which will be replaced with sirolimus at later stage of the study.",[13,14,15,16,22],"Drug: Sirolimus",[24,31,37,43,49],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Cyclosporine","Cyclosporine tablets orally once daily at dose level adapted to maintain concentration at 2 hours after administration (C2): 1000-1500 nanogram per milliliter (ng\u002FmL) during Day 0 to Week 4, and 800-1200 ng\u002FmL during Week 4 to Week 52. For Mycophenoate Mofetil + Sirolimus treatment arm, at Week 12, dose of cyclosporine will be reduced by 50% for 3 days, followed by 1\u002F4 of the dose for 3 days, and then cyclosporine will be stopped.",[9,18],[30],"Neoral",{"type":25,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Daclizumab","Daclizumab 2 milligram (mg) per kilogram (kg) will be administered as intravenous infusion over 15 minute on Day 0 (during the 24 hours preceding renal transplantation) and at a dose of 1 mg\u002Fkg on Day14.",[9,18],[36],"Zenapax",{"type":25,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Mycophenoate Mofetil","Mycophenoate mofetil 1 gram (g) (2\\*500mg tablets or 4\\*250mg capsules) will be given twice daily (daily dose of 2 g) orally for 12 months.",[9,18],[42],"CellCept",{"type":25,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Prednisolone","Prednisolone 250 mg intravenously on Day 0, followed by 0.5 mg\u002Fkg orally daily (maximum 40 mg daily) from Day 1 to Day 7, then 0.25 mg\u002Fkg orally daily (maximum 20 mg daily), then dose will be stepwise reduced by 2.5 mg per week to reach to a dose level of 10 mg daily and continued up to 6 months and finally drug will be discontinued after 8 months.",[9,18],[48],"Solupred",{"type":25,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"Sirolimus","Sirolimus tablets will be given orally from week 12 to week 52, starting with loading dose of 10 mg daily for 2 days followed by 6 mg daily to adapt to trough concentrations of 8-15 ng\u002FmL from week 12 to week 39, and 5-10 ng\u002FmL from week 39 to week 52.",[18],[54],"Rapamycin",[56],{"name":57,"affiliation":5,"role":58},"Clinical Trials","STUDY_CHAIR",null,[61,72,80,88,96,104,112,120,128,133,138,146,154,162,170,178,186],{"facility":59,"status":59,"city":62,"state":59,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":59},"Angers","49933","France","FR",{"type":67,"coordinates":68},"Point",[69,70],-0.55202,47.47156,{"lat":70,"lon":69},{"facility":59,"status":59,"city":73,"state":59,"zip":74,"country":64,"countryCode":65,"cosmosGeoPoint":75,"geoPoint":79,"contacts":59},"Caen","14033",{"type":67,"coordinates":76},[77,78],-0.35912,49.18585,{"lat":78,"lon":77},{"facility":59,"status":59,"city":81,"state":59,"zip":82,"country":64,"countryCode":65,"cosmosGeoPoint":83,"geoPoint":87,"contacts":59},"Clermont-Ferrand","63000",{"type":67,"coordinates":84},[85,86],3.08682,45.77969,{"lat":86,"lon":85},{"facility":59,"status":59,"city":89,"state":59,"zip":90,"country":64,"countryCode":65,"cosmosGeoPoint":91,"geoPoint":95,"contacts":59},"La Tronche","38700",{"type":67,"coordinates":92},[93,94],5.74629,45.20507,{"lat":94,"lon":93},{"facility":59,"status":59,"city":97,"state":59,"zip":98,"country":64,"countryCode":65,"cosmosGeoPoint":99,"geoPoint":103,"contacts":59},"Lille","59037",{"type":67,"coordinates":100},[101,102],3.05512,50.63391,{"lat":102,"lon":101},{"facility":59,"status":59,"city":105,"state":59,"zip":106,"country":64,"countryCode":65,"cosmosGeoPoint":107,"geoPoint":111,"contacts":59},"Limoges","87042",{"type":67,"coordinates":108},[109,110],1.24759,45.83362,{"lat":110,"lon":109},{"facility":59,"status":59,"city":113,"state":59,"zip":114,"country":64,"countryCode":65,"cosmosGeoPoint":115,"geoPoint":119,"contacts":59},"Lyon","69437",{"type":67,"coordinates":116},[117,118],4.84789,45.74906,{"lat":118,"lon":117},{"facility":59,"status":59,"city":121,"state":59,"zip":122,"country":64,"countryCode":65,"cosmosGeoPoint":123,"geoPoint":127,"contacts":59},"Paris","75018",{"type":67,"coordinates":124},[125,126],2.3488,48.85341,{"lat":126,"lon":125},{"facility":59,"status":59,"city":121,"state":59,"zip":129,"country":64,"countryCode":65,"cosmosGeoPoint":130,"geoPoint":132,"contacts":59},"75475",{"type":67,"coordinates":131},[125,126],{"lat":126,"lon":125},{"facility":59,"status":59,"city":121,"state":59,"zip":134,"country":64,"countryCode":65,"cosmosGeoPoint":135,"geoPoint":137,"contacts":59},"75743",{"type":67,"coordinates":136},[125,126],{"lat":126,"lon":125},{"facility":59,"status":59,"city":139,"state":59,"zip":140,"country":64,"countryCode":65,"cosmosGeoPoint":141,"geoPoint":145,"contacts":59},"Poitiers","86021",{"type":67,"coordinates":142},[143,144],0.34348,46.58261,{"lat":144,"lon":143},{"facility":59,"status":59,"city":147,"state":59,"zip":148,"country":64,"countryCode":65,"cosmosGeoPoint":149,"geoPoint":153,"contacts":59},"Reims","51092",{"type":67,"coordinates":150},[151,152],4.02853,49.26526,{"lat":152,"lon":151},{"facility":59,"status":59,"city":155,"state":59,"zip":156,"country":64,"countryCode":65,"cosmosGeoPoint":157,"geoPoint":161,"contacts":59},"Rennes","35033",{"type":67,"coordinates":158},[159,160],-1.67431,48.11109,{"lat":160,"lon":159},{"facility":59,"status":59,"city":163,"state":59,"zip":164,"country":64,"countryCode":65,"cosmosGeoPoint":165,"geoPoint":169,"contacts":59},"Rouen","76031",{"type":67,"coordinates":166},[167,168],1.09932,49.44313,{"lat":168,"lon":167},{"facility":59,"status":59,"city":171,"state":59,"zip":172,"country":64,"countryCode":65,"cosmosGeoPoint":173,"geoPoint":177,"contacts":59},"Salouël","80480",{"type":67,"coordinates":174},[175,176],2.2434,49.86988,{"lat":176,"lon":175},{"facility":59,"status":59,"city":179,"state":59,"zip":180,"country":64,"countryCode":65,"cosmosGeoPoint":181,"geoPoint":185,"contacts":59},"Strasbourg","67091",{"type":67,"coordinates":182},[183,184],7.74553,48.58392,{"lat":184,"lon":183},{"facility":59,"status":59,"city":187,"state":59,"zip":188,"country":64,"countryCode":65,"cosmosGeoPoint":189,"geoPoint":193,"contacts":59},"Tours","37044",{"type":67,"coordinates":190},[191,192],0.70398,47.39484,{"lat":192,"lon":191},{"type":195,"investigatorFullName":59,"investigatorTitle":59,"investigatorAffiliation":59,"oldNameTitle":59,"oldOrganization":59},"SPONSOR","100261749","phase-3-study-comparing-efficacy-and-safety-of-mycophenolate-mofetil-cellcept-with-delayed-introduction-of-sirolimus-and-discontinuation-of-cyclosporine-with-those-of-mycophenolate-mofetil-and-long-term-continuation-of-cyclosporine-in-renal-transplant-recipients-100261749",false,"NCT02686619","Study Comparing Efficacy and Safety of Mycophenolate Mofetil (Cellcept) With Delayed Introduction of Sirolimus and Discontinuation of Cyclosporine, With Those of Mycophenolate Mofetil and Long Term Continuation of Cyclosporine in Renal Transplant Recipients","Multicentre, Prospective, Randomized, Open-label Study Comparing the Efficacy and Safety of CellCept With Delayed Introduction of Sirolimus and Discontinuation of Cyclosporine, With Those of Standard Immunosuppression Comprising CellCept and Long-term Continuation of Cyclosporine in Renal Transplant Recipients Receiving Induction by Zenapax and Treated With Corticosteroids for 8 Months","Inclusion Criteria:\n\n* Receipt of a first cadaveric kidney graft\n* Antilymphocyte antibodies and panel reactive antibodies (PRA) less than 30 percent (%) (historical peak and\u002For current value)\n* Cold ischaemia time less than or equal to 36 hours\n\nExclusion Criteria:\n\n* Kidney from a living donor; donor greater than (\\>) 65 years of age; second renal graft, or more; or multiple organ transplant\n* Known hypersensitivity to any of the drugs in the study or their components\n* History of cancer or malignancy during previous 5 years, other than successfully treated spinocellular or basal cell cancer\n* Participant presenting, on inclusion, either symptoms suggestive of active gastroduodenal ulcer, or gastroduodenal ulcer confirmed by fibroscopy and biopsy, and requiring treatment\n* Participant with severe refractory hyperlipidaemia\n* Pregnant woman or nursing mother\n\nExclusion Criteria for Follow-up Phase:\n\n* Episode of acute rejection greater than or equal to grade I (Banff classification)\n* Estimated creatinine clearance (CrCl) at week 12 less than (\\\u003C) 40 milliliter per minute (mL\u002Fmin) (Cockcroft-Gault formula)\n* Serum creatinine variations \\>30% during the 15 days before randomization\n* Proteinuria \\>1 gram\u002F24 hour, or mean mycophenolate mofetil dose \\\u003C 1.5 gram\u002Fday during the week before randomization","ALL","18 Years","75 Years",{"count":207,"type":208},237,"ACTUAL","INTERVENTIONAL",[211],"PHASE3","This multicentre, prospective, randomized, open-label study will compare the safety and efficacy of mycophenolate mofetil with delayed introduction of sirolimus and discontinuation of cyclosporine, with those of mycophenolate mofetil and long term continuation of cyclosporine in renal transplant recipients receiving daclizumab (Zenapax) as induction treatment and followed by 8 month treatment with corticosteroids. The anticipated time on study treatment is 12 months. Participants who will complete the initial 12-month study and who will provide written informed consent will be eligible to participate in a 60-month follow-up phase.",[214],"Renal Transplantation","COMPLETED","2016-02-16",{"date":218,"type":219},"2016-02-19","ESTIMATED",{"date":221,"type":59},"2004-11",{"date":223,"type":208},"2011-01",{"name":5,"class":6},17]