[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589931":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":45,"responsibleParty":60,"collaborators":10,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":10,"enrollmentInfo":72,"targetDuration":10,"studyType":75,"phases":10,"briefSummary":76,"conditions":77,"keywords":10,"overallStatus":79,"whyStopped":10,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Chiesi SAS","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort of patients treated",null,"Cohort of patients treated with Life-Cycle Pharma Tacrolimus-based immunosuppression: Our single-arm study addresses the primary objective.",[13,14],"Drug: Life-Cycle Pharma Tacrolimus","Procedure: Kidney transplantation",{"label":16,"type":10,"description":17,"interventionNames":18},"Reference cohort for transplants","Cohorts Transplant reference: two control groups (Tacrolimus twice daily (IR-Tac) and Tacrolimus once daily (ER-Tac)) to determine the main secondary objective.",[14],[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DRUG","Life-Cycle Pharma Tacrolimus","Patients receiving LCPT Envarsus® \\[Life-Cycle Pharma Tacrolimus\\] within 24 hours of kidney transplantation in a once-daily formulation at the discretion of the investiga-tor and in compliance with the summary of product characteristics (SmPC).",[9],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"PROCEDURE","Kidney transplantation","Kidney transplant patients using the iBox prognostic system (risk prediction system for kidney transplants)",[9,16],[31],{"name":32,"affiliation":33,"role":34},"Philippe GATAULT, MD","CHRU TOURS","PRINCIPAL_INVESTIGATOR",[36,41],{"name":32,"role":37,"phone":38,"phoneExt":39,"email":40},"CONTACT","247366392","+33","philippe.gatault@univ-tours.fr",{"name":42,"role":37,"phone":43,"phoneExt":39,"email":44},"Yoni ATHEA, Dr.","147684930","y.athea@chiesi.com",[46],{"facility":47,"status":10,"city":48,"state":10,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Chru Tours","Tours","37044","France","FR",{"type":53,"coordinates":54},"Point",[55,56],0.70398,47.39484,{"lat":56,"lon":55},[59],{"name":32,"role":37,"phone":38,"phoneExt":39,"email":40},{"type":61,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100589931","real-word-study-of-the-de-novo-extended-release-tacrolimus-in-kidney-transplantation-using-an-artificial-intelligence-100589931",false,"NCT06960824","Real-word Study of the de NOVO Extended-release tacrolimuS in Kidney Transplantation Using an ARTificial Intelligence","Real-word Study of the de NOVO Use of Once-daily Extended-release tacrolimuS (LCPT) in Kidney Transplantation Using an ARTificial Intelligence Prognostic System: a Multicenter Prospective Ob-servational Study","NOVOSTART","Inclusion Criteria:\n\n* Kidney recipients aged 18 years and older.\n* Kidney recipients were transplanted from living or deceased donors\n* Patients receiving Envarsus® \\[Life-Cycle Pharma Tacrolimus\\] within 24 hours of kidney transplantation in a once-daily formulation at the discretion of the investiga-tor and in compliance with the summary of product characteristics.\n* Patients are willing to participate in the study and do not oppose the use of their data.\n* Patients are either affiliated with or beneficiaries of a social security scheme.\n\nExclusion Criteria:\n\n* Contraindications to the use of Life-Cycle Pharma Tacrolimus (Envarsus®).\n* Pre-transplant desensitization.\n* ABO is incompatible with a living donor.\n* Combined transplant (e.g. kidney-heart transplant, kidney-liver transplant).\n* Previous bariatric (or bypass) surgery.\n* Gastrointestinal problems are likely to affect the absorption of the Life-Cycle Pharma Tacrolimus (Envarsus®).\n* Diagnosis of Parkinson's disease or any other neurological syndrome causing tremor.\n* Patients who are part of another clinical trial or in a period of exclusion from another clinical trial with a molecule under study.\n* Pregnant women or breastfeeding.\n* Patients under legal protection (guardianship, curatorship) or deprived of their liberty through judicial or administrative decisions.\n* Patients under State Medical Assistance.","ALL","18 Years",{"count":73,"type":74},165,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to assess the clinical efficacy of the LCPT En-varsus \\[Life-Cycle Pharma Tacrolimus\\] initiated in de novo (Day 0 of transplantation) using the Biopsy Proven Acute Re-jection and iBox (full and abbreviated algo-rithms).",[78],"Chronic Renal Disease","NOT_YET_RECRUITING","2025-04-29",{"date":82,"type":83},"2025-05-07","ACTUAL",{"date":85,"type":74},"2025-05",{"date":87,"type":74},"2027-12-31",{"name":5,"class":6},1]