[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625390":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":25,"studyPopulation":26,"armGroups":27,"interventions":33,"overallOfficials":39,"centralContacts":44,"locations":54,"responsibleParty":68,"collaborators":70,"id":75,"slug":21,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":21,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":21,"studyType":87,"phases":21,"briefSummary":88,"conditions":89,"keywords":21,"overallStatus":92,"whyStopped":21,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Baylor Research Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Understanding Tacrolimus Levels in Pregnancy","Develop a joint non-linear mixed effect population pharmacokinetic model describing bound and unbound tacrolimus pharmacokinetics in pregnant subjects.","2nd (weeks 13-26) and 3rd (weeks 27-40) trimester of pregnancy",[14,17],{"measure":15,"description":16,"timeFrame":12},"Adjusting Tacrolimus Blood Levels by Trimester","Create an equation to adjust whole blood tacrolimus concentrations for changes in drug binding during each trimester at the point of care",{"measure":18,"description":19,"timeFrame":20},"Linking the Mixed Pharmacokinetic Model and the Equation to Adjust Whold Blood Tacrolimus Concentrations to Active Tacrolimus Levels During and After Pregnancy","Correlate clinical outcomes with estimated unbound tacrolimus concentrations from uterus transplant recipients during each trimester and outside of pregnancy using whole blood trough concentrations and the model developed in Outcome 1","1 week postpartum, 4 weeks, 5 weeks and 6 weeks postpartum",null,{"allocation":21,"interventionModel":21,"interventionModelDescription":21,"primaryPurpose":21,"observationalModel":23,"timePerspective":24,"maskingInfo":21},"CASE_ONLY","PROSPECTIVE","A non-linear mixed effects model describing tacrolimus exposure in pregnant and non-pregnant subjects will be developed using prospectively collected de-identified data from pregnant uterus transplant recipients at BUMC.\n\nThe model will be analyzed to develop an estimating equation for tacrolimus unbound concentrations from whole blood concentrations, albumin and hematocrit during each trimester of pregnancy.\n\nThe estimating equation will then be applied to data from uterus transplant recipients enrolled in this study and retrospectively to uterus recipients transplanted since October 2020 to clinically validate the findings.","Uterus transplant recipient over 18 years of age receiving tacrolimus for immunosuppression.",[28],{"label":29,"type":21,"description":30,"interventionNames":31},"Pregnant Individuals","Individuals who had a uterus transplant that are using tacrolimus during pregnancy.",[32],"Biological: Modeling of unbound and whole blood tacrolimus in pregnant uterus transplant recipients",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":21},"BIOLOGICAL","Modeling of unbound and whole blood tacrolimus in pregnant uterus transplant recipients","Develop an estimating equation to correct tacrolimus whole blood concentrations given the known increase in the unbound tacrolimus concentration in pregnant patients to obtain a more accurate picture of active tacrolimus exposure (unbound drug) in pregnant uterus transplant recipients.",[29],[40],{"name":41,"affiliation":42,"role":43},"Nicole Wilson, Pharmacist","Baylor Scott and White Health","PRINCIPAL_INVESTIGATOR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":21,"email":49},"Ashley McAllister","CONTACT","214-820-1710","ashley.mcallister@bswhealth.org",{"name":51,"role":47,"phone":52,"phoneExt":21,"email":53},"Taryn Kruse","214-820-1767","taryn.kruse@bswhealth.org",[55],{"facility":56,"status":21,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":21},"Baylor University Center of Dallas","Dallas","Texas","75246","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-96.80667,32.78306,{"lat":66,"lon":65},{"type":69,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR",[71,73],{"name":72,"class":6},"Children's Hospital Medical Center, Cincinnati",{"name":74,"class":6},"University of Washington","100625390",false,"NCT07422012","Tacrolimus in Pregnancy","Optimization of Tacrolimus Management During Pregnancy: Modeling of Unbound and Whole Blood Tacrolimus in Pregnant Uterus Transplant Recipients","Inclusion Criteria:\n\n* Uterus transplant recipient\n* 18 to 50 years of age\n* receiving tacrolimus for immunosuppression.\n\nExclusion Criteria:\n\n* Individuals who have not had a uterine transplant\n* individuals over 50 years old","FEMALE","18 Years","50 Years",{"count":85,"type":86},55,"ESTIMATED","OBSERVATIONAL","To create a formula that adjusts tacrolimus blood levels. This is needed because pregnant patients have higher levels of unbound tacrolimus. The adjusted formula will give a more accurate measure of the active drug in pregnant uterus transplant patients.",[90,91],"Unbound Tacrolimus in Pregnant Uterus Transplant Recipients","Whole Blood Tacrolimus in Pregnant Uterus Transplant Recipients","NOT_YET_RECRUITING","2026-04-24",{"date":95,"type":96},"2026-04-28","ACTUAL",{"date":98,"type":86},"2026-05-31",{"date":100,"type":86},"2028-03",{"name":5,"class":6},1]