[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"immunosuppression-related-infectious-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:immunosuppression-related-infectious-disease":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"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":19,"type":20},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.",[24,25],"Kidney Transplant Failure and Rejection","Immunosuppression-related Infectious Disease",[27,28,29,30,31],"Kidney transplantation","Pharmacokinetic","Tacrolimus","Concentration-dose ratio","Pharmacogenetic","RECRUITING","2021-02-09",{"date":35,"type":36},"2021-02-10","ACTUAL",{"date":38,"type":36},"2020-07-28",{"date":40,"type":20},"2027-08-01",{"name":42,"class":43},"University Hospital, Grenoble","OTHER",2,""]