[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100178345":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":11,"locations":28,"responsibleParty":50,"collaborators":52,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":11,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":81,"whyStopped":11,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Centre Hospitalier Universitaire, Amiens","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cyclosporin + Mycophenolate mofetil","ACTIVE_COMPARATOR",null,[13],"Drug: cyclosporin + mycophenolate mofetil",{"label":15,"type":16,"description":11,"interventionNames":17},"Everolimus + mycophenolate mofetil","EXPERIMENTAL",[18],"Drug: everolimus + mycophenolate mofetil",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","cyclosporin + mycophenolate mofetil","antirejection drug, renal transplantation",[9],{"type":21,"name":26,"description":23,"armGroupLabels":27,"otherNames":11},"everolimus + mycophenolate mofetil",[15],[29,41],{"facility":30,"status":11,"city":31,"state":11,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":11},"Nephrology department, Hospital University of Amiens","Amiens","80000","France","FR",{"type":36,"coordinates":37},"Point",[38,39],2.3,49.9,{"lat":39,"lon":38},{"facility":42,"status":11,"city":43,"state":11,"zip":44,"country":33,"countryCode":34,"cosmosGeoPoint":45,"geoPoint":49,"contacts":11},"Nephrology Department, University Hospital of Montpellier","Montpellier","34285",{"type":36,"coordinates":46},[47,48],3.87635,43.61093,{"lat":48,"lon":47},{"type":51,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[53],{"name":54,"class":55},"Novartis","INDUSTRY","100178345","phase-3-comparison-of-efficacy-and-safety-of-treatment-with-a-calcineurin-inhibitor-cniversus-a-cni-free-treatment-in-renal-transplantation-cime-100178345",false,"NCT01595984","Comparison of Efficacy and Safety of Treatment With a Calcineurin Inhibitor (CNI)Versus a CNI-free Treatment in Renal Transplantation (CIME)","Randomized, Multicenter, Open-label, Comparative Study of Efficacy and Safety of Treatment With a Calcineurin Inhibitor (CNI), Associating Myfortic ® and Neoral ® Compared to a CNI-free Treatment, Combining Myfortic ® and Certican ® , in Adult Patients With de Novo Renal Transplant","CIME","Inclusion Criteria:\n\n* Males and Females aged between 18 and 70.\n* Patient receiving a first or second kidney transplant from a deceased donor, living related or unrelated.\n* Patient with a maximum PRA \\\u003C20%.\n* Patient wishing and being able to participate fully to the study, and having given a written consent.\n* Patient covered by a social insurance or beneficiary of such a regime.\n* Women of childbearing age must use a recognized method of contraception throughout the study period and continue for 8 weeks after discontinuation of study treatment.\n\nExclusion Criteria:\n\n* Patient receiving a kidney from a heart attack donor , or an ABO incompatible donor or a donor with a positive T-cross match.\n* Patient with a maximum PRA\\> 20% twice.\n* Cold ischemic time \\> 36 hours.\n* Patients with thrombocytopenia (\\\u003C75000\u002Fmm3), neutropenia (\\\u003C1 500 \u002F mm3), leukopenia (\\\u003C2 500 \u002F mm3) or a hemoglobin concentration \\\u003C8 g \u002F dl, at inclusion visit.\n* Patient with severe hyperlipidemia: total cholesterol ≥ 9 mmol \u002F l (≥ 3.50 g \u002F l) and \u002F or triglycerides ≥ 8.5 mmol\u002Fl (≥ 7.5 g \u002F l) despite appropriate lipid-lowering therapy.\n* Patient with known HIV positive status, know active hepatitis B or C. Recipients of an organ from a donor with positive HIV status, hepatitis B or hepatitis C are excluded.\n* Patient with severe systemic infections requiring continued therapy.\n* Treatment with an experimental drug within 4 weeks before the first dose of study treatment.\n* Patient for whom the initial disease or other pathology requires a long-term corticosteroid treatment.\n* Patient with a history of hypersensitivity or known contra-indications for macrolide or inhibitors of mTORs drugs; drugs similar to Myfortic ® (ERL080) or other components of the formulation such as lactose, or cyclosporine, or prednisone (Cortancyl ®), or Thymoglobuline ® or Iohexol.\n* Patient with a malignant disease or a history of malignancy over the past 5 years except squamous-cell or basal cell carcinoma wich was excised.\n* Medical condition or surgical procedure, except transplantation, which could exclude the patient in the opinion of the investigator.\n* Patient with symptoms of mental or significant somatic illness. Disability to cooperate or communicate with the investigator.\n* Pregnant, sucking or of childbearing age and refusing or being unable to use a recognized contraceptive method.\n* Patient under guardianship, or any patient protected by law.","ALL","18 Years","70 Years",{"count":68,"type":69},88,"ACTUAL","INTERVENTIONAL",[72],"PHASE3","The main objective of this protocol is to compare the impact on renal function of two different immunosuppressive regimens in patients with de novo renal transplant.\n\nRenal function will be accurately evaluated by measuring the clearance of iohexol.\n\nThe protocol will also evaluate the efficacy and safety in a short term of these two different immunosuppressive regimens.",[75],"Kidney Failure",[77,78,79,80],"kidney","transplantation","graft","creatinin","COMPLETED","2026-06-10",{"date":84,"type":69},"2026-06-12",{"date":86,"type":69},"2012-05-03",{"date":88,"type":69},"2024-03-05",{"name":5,"class":6},2]