[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652185":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":10,"locations":10,"responsibleParty":12,"collaborators":10,"id":16,"slug":17,"hasResults":18,"nctId":19,"briefTitle":20,"officialTitle":21,"acronym":10,"eligibilityCriteria":22,"healthyVolunteers":18,"sex":23,"minAge":24,"maxAge":10,"enrollmentInfo":25,"targetDuration":10,"studyType":28,"phases":10,"briefSummary":29,"conditions":30,"keywords":32,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":10},{"fullName":5,"class":6},"Children's Hospital Medical Center, Cincinnati","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Longitudinal Self-Sampling for Immunosuppression Pharmacokinetics",null,"Cohort of pediatric kidney transplant recipients self-collecting blood samples for assessment of intrapatient pharmacokinetic variability over 1 year",{"type":13,"investigatorFullName":14,"investigatorTitle":15,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Abbie Leino","Assistant Professor","100652185","optimization-of-therapeutic-drug-monitoring-in-pediatric-kidney-transplant-100652185",false,"NCT07769567","Optimization of Therapeutic Drug Monitoring in Pediatric Kidney Transplant","Optimization of Therapeutic Drug Monitoring for Tacrolimus and Mycophenolate in Pediatric Kidney Transplant Recipients: a PK\u002FPD Study","Inclusion Criteria:\n\n* Recipient of a solid organ transplant and at least 1 year of age\n* Receiving tacrolimus and\u002For mycophenolate\n* Patient and\u002For caregiver is willing to receive text notifications and has a mobile device capable of receiving and sending text and multimedia messages.\n* Ability to understand and willingness to sign a written informed consent\n* Ability to understand, read, and speak English.\n\nExclusion Criteria:\n\n* History of allergy to tape adhesives","ALL","1 Year",{"count":26,"type":27},25,"ESTIMATED","OBSERVATIONAL","The goal of this observational, pharmacokinetic study is to evaluate factors that change drug exposure in pediatric kidney transplant recipients so investigators can make better dosing decisions. The main question it aims to answer is:\n\nCan investigators quantify the impact of factors that change with time (like food intake and medication adherence) on tacrolimus and mycophenolate? Our hypothesis is that inconsistent drug and food intake will increase day to day variability in drug exposure, and investigators can use this information to help us make decisions about what is the best dose.\n\nParticipants will participate in the study on 7 days over the course of 1 year. On day 1, participants will be asked questions to see if participants are able to be in this study. Investigators will ask what immunosuppression participants are taking, how tall and how much participants weigh.\n\nOn day 2, participants and their parent\u002Fguardian will be taught how to use the device to collect the blood samples and decide on which days to collect them.\n\nOn days 3-6, participants will collect blood samples 4 separate times over about 1 year. Collection days should try to be scheduled every 3 months (+\u002F- 2 weeks).\n\nOn each collection day, participants will collect a sample 7 different times over 9 hours. Each collection will only take approximately 5 minutes. Participants will be asked to collect a blood sample immediately before the morning dose of tacrolimus or mycophenolate, and 20 min, 1hr, 3hr, 4hr, 6hr, 9hr after the dose.\n\nAlso on collection days, participants will receive text messages and be asked to complete different assessments about their medications, diet, and how they feel by responding to the texts.\n\nOn day 7, participants will have the opportunity to participate in an interview where investigators will ask about participants' experience in the study.",[31],"Kidney Transplant",[33,34,35,36,37],"tacrolimus","mycophenolate","pharmacokinetics","pediatrics","microsampling","NOT_YET_RECRUITING","2026-08-17",{"date":41,"type":42},"2026-08-19","ACTUAL",{"date":44,"type":27},"2026-09-01",{"date":46,"type":27},"2028-12-31",{"name":5,"class":6}]