[{"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":46},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100402910","tacrolimus-pharmacokinetic-subpopulations-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":20,"type":21},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.",[25,26],"Kidney Transplant Failure and Rejection","Immunosuppression-related Infectious Disease",[28,29,30,31,32],"Kidney transplantation","Pharmacokinetic","Tacrolimus","Concentration-dose ratio","Pharmacogenetic","RECRUITING","2021-02-09",{"date":36,"type":37},"2021-02-10","ACTUAL",{"date":39,"type":37},"2020-07-28",{"date":41,"type":21},"2027-08-01",{"name":43,"class":44},"University Hospital, Grenoble","OTHER",2,"Immunosuppression Related Infectious Disease"]