[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100402910":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":31,"locations":39,"responsibleParty":75,"collaborators":77,"id":80,"slug":10,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":10,"enrollmentInfo":89,"targetDuration":10,"studyType":92,"phases":10,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":42,"whyStopped":10,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"University Hospital, Grenoble","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tacrolimus once-daily",null,"Patients receiving tacrolimus as a once-daily formulation (Envarsus)",[13],"Drug: Dosage Forms Oral",{"label":15,"type":10,"description":16,"interventionNames":17},"Tacrolimus bid","Patients receiving tacrolimus as a twice-a-day formulation.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DRUG","Dosage Forms Oral","Dosage form of tacrolimus (extended release tacrolimus or immediate release tacrolimus)",[15,9],[25,28],{"name":26,"affiliation":5,"role":27},"Thomas JOUVE, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":29,"affiliation":5,"role":30},"Lionel ROSTAING, MD, PhD","STUDY_CHAIR",[32,36],{"name":26,"role":33,"phone":34,"phoneExt":10,"email":35},"CONTACT","+33476765460","tjouve@chu-grenoble.fr",{"name":37,"role":33,"phone":34,"phoneExt":10,"email":38},"Johan NOBLE, MD","jnoble@chu-grenoble.fr",[40,60],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Grenoble University Hospital","RECRUITING","Grenoble","Auvergne-Rhône-Alpes","38043","France",{"type":48,"coordinates":49},"Point",[50,51],5.71479,45.17869,{"lat":51,"lon":50},[54,57],{"name":55,"role":33,"phone":34,"phoneExt":10,"email":56},"Mathilde BUGNAZET","mbugnazet@chu-grenoble.fr",{"name":58,"role":33,"phone":34,"phoneExt":10,"email":59},"David TARTRY","dtartry@chu-grenoble.fr",{"facility":61,"status":62,"city":63,"state":44,"zip":64,"country":46,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Saint Etienne University Hospital","NOT_YET_RECRUITING","Saint-Etienne","42000",{"type":48,"coordinates":66},[67,68],4.39,45.43389,{"lat":68,"lon":67},[71],{"name":72,"role":33,"phone":73,"phoneExt":10,"email":74},"Guillaume CLAISSE, MD","+33477828380","guillaume.claisse@chu-st-etienne.fr",{"type":76,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[78],{"name":79,"class":6},"Chiesi SA\u002FNV","100402910",false,"NCT04526431","Tacrolimus Pharmacokinetic Subpopulations","Tacrolimus Pharmacokinetic Subpopulations: Prospective Mechanistic Investigations of the Tacrolimus C\u002FD Ratio","TIPS","Inclusion Criteria:\n\n* Kidney transplant patients at the CHUGA, CHU Saint-Etienne or CHU Clermont-Ferrand, whose new transplant is no more than 7 days old (inclusive)\n* Patients initially treated with tacrolimus as an immunosuppressant, combined with mycophenolate (MMF), mycophenolic acid (MPA) or everolimus (EVR), with or without corticotherapy.\n* No plans to remove tacrolimus from the patient's immunosuppressive treatment (e.g. no plans to switch to belatacept a priori), during the first 4 years post-transplantation.\n* Affiliation to or beneficiary of a social security scheme\n* Able to read and understand the terms of the protocol\n* Informed consent obtained, including specific consent for genetic analysis of target genes.\n* For women of childbearing potential, presence of effective contraception (already acquired for patients treated with mycophenolic acid as an immunosuppressant).\n\nExclusion Criteria:\n\n* Contraindication to the use of tacrolimus\n* Patient already treated with tacrolimus at the time of transplantation\n* Pregnant, parturient or breastfeeding women\n* Patient deprived of liberty by judicial or administrative decision\n* Patient under guardianship or curatorship, or receiving forced psychiatric care\n* Person admitted to a health or social institution\n* Subject cannot be contacted in case of emergency\n* Subject in period of exclusion from another study","ALL","18 Years",{"count":90,"type":91},180,"ESTIMATED","OBSERVATIONAL","This prospective study will investigate the concentrations of tacrolimus metabolites (M-I and M-III) over the four first years post-transplantation.\n\nA differential metabolism might result in different metabolites' concentration and explain a kidney survival difference between \"high rate metabolism\" (defined as a concentration\u002Fdose ratio, C\u002FD ratio, lower than 1.04 µg\u002Fl\u002Fmg) and other patients.\n\nThe primary endpoint is therefore to compare tacrolimus metabolites' concentrations with respect to the group, either \\\u003C or \\>= 1.04 µg\u002Fl\u002Fmg, in order to detect differences in tacrolimus metabolization between these groups.",[95,96],"Kidney Transplant Failure and Rejection","Immunosuppression-related Infectious Disease",[98,99,100,101,102],"Kidney transplantation","Pharmacokinetic","Tacrolimus","Concentration-dose ratio","Pharmacogenetic","2021-02-09",{"date":105,"type":106},"2021-02-10","ACTUAL",{"date":108,"type":106},"2020-07-28",{"date":110,"type":91},"2027-08-01",{"name":5,"class":6},2]