[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556778":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":35,"centralContacts":41,"locations":46,"responsibleParty":73,"collaborators":22,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":22,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":49,"whyStopped":22,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Murdoch Childrens Research Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Prospective Cohort: Pre-emptive CYP3A5\u002F3A4 genotype combined with a Bayesian dose prediction","EXPERIMENTAL","Planned SOT recipients where initial tacrolimus dosing will be based on genotype and subsequent doses predicted using Bayesian revised dosing using NextDose. NextDose, a web-based tool is a model-informed precision dosing software tool used to optimise dosage regimens. It uses Bayesian statistics to integrate prior drug information from a population pharmacokinetic (popPK) model, individual characteristics, and drug concentrations to provide the most accurate individual pharmacokinetic (PK) estimates. The popPK model, a mathematical-statistical model developed from real patient data, captures the drug's typical pharmacokinetics, its variability among individuals and over time, and the factors influencing this variability. By leveraging prior knowledge about a drug's PK along with individual patient data and drug concentrations, the software accurately estimates individual PK parameters with minimal drug concentration data. Tacrolimus dose, form, frequency, \\& duration will be assessed",[13,14,15],"Diagnostic Test: Genotyping for CYP3A4 and CYP3A5 genes","Device: Use of NextDose platform","Drug: Tacrolimus",[17,23,28],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DIAGNOSTIC_TEST","Genotyping for CYP3A4 and CYP3A5 genes","Genotyping: Patients in the prospective (intervention) arm will undergo genotyping using Illumina's genome-wide genotyping array (Infinium Global Screening Array). Pre-transplant genotyping will test for CYP3A5 \\*3, \\*6, \\*7, \\*8 and \\*9 alleles, and will test for CYP3A4\\*22 only (with CYP3A4\\*1 reported if no variant corresponding to \\*22 was present).\n\nThe determined diplotypes for CYP3A5 will be matched with predicted phenotypes using the Clinical Pharmacogenetics Implementation Consortium (CPIC®) proposed genotype-to-phenotype translation table. The assignment of the phenotype is outlined in the CPIC guidelines which will used to predict initial dose of tacrolimus. In addition, influence of CYP3A4 will be incorporated based on recent literature and interventional trials. Initial dose in BRUNO-PIC will use allometric size scaling from adult dose, with adjustment based on genotype (CYP3A4 \\& CYP3A5)",[9],null,{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":22},"DEVICE","Use of NextDose platform","NextDose platform is a forecasting tool used to predict tacrolimus dosage. It is a freely available tool and will be used in accordance with guideline. The dosing recommendations will be led by the academic pharmacist in consultation with the PI. This tool will use genotype-informed Bayesian dosing to help predict the time course of tacrolimus concentrations in the body.",[9],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Tacrolimus","Tacrolimus is administered to all patients post SOT at The Royal Children's Hospital (RCH)",[9],[34],"Prograf (Brand)",[36,39],{"name":37,"affiliation":5,"role":38},"Rachel Conyers","PRINCIPAL_INVESTIGATOR",{"name":40,"affiliation":5,"role":38},"David Metz, MBBS, PhD",[42],{"name":37,"role":43,"phone":44,"phoneExt":22,"email":45},"CONTACT","03 9936 6770","pharmaco.genomics@mcri.edu.au",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Royal Children's Hospital","RECRUITING","Melbourne","Victoria","3052","Australia","AU",{"type":56,"coordinates":57},"Point",[58,59],144.96332,-37.814,{"lat":59,"lon":58},[62,65,69,71],{"name":63,"role":43,"phone":64,"phoneExt":22,"email":45},"Dhrita Khatri","03 9936 6087",{"name":66,"role":43,"phone":67,"phoneExt":22,"email":68},"David Metz","03 9345 5533","david.metz@rch.org.au",{"name":70,"role":38,"phone":22,"phoneExt":22,"email":22},"A\u002FProf Rachel Conyers",{"name":72,"role":38,"phone":22,"phoneExt":22,"email":22},"A\u002FProf David Metz",{"type":74,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100556778","phase-4-utilising-genotype-informed-bayesian-dosing-of-tacrolimus-in-children-post-solid-organ-transplantation-100556778",false,"NCT06529536","Utilising Genotype Informed Bayesian Dosing of Tacrolimus in Children Post Solid Organ Transplantation.","Genotype Informed Bayesian Dosing of Tacrolimus in Solid Organ Transplant- Pharmacogenomic Implementation in Children","BRUNO-PIC","Participants will be assigned to the prospective arm if treated at Royal Children's Hospital who are receiving a solid organ transplant (SOT) (excluding repeat graft in liver transplant recipients, or lung or intestinal transplant) and who will be on tacrolimus as one of the main immunosuppressants post-transplant.\n\nInclusion Criteria:\n\n* Age 1-18 years of age\n* Kidney, liver or heart transplant recipients\n* Participant and\u002For parent consent to the study (prospective arm only)\n\nExclusion Criteria:\n\n* Previous liver transplant.\n* Lung OR Intestinal transplant.\n* Insufficient time before transplant for pharmacogenomic analysis (prospective arm only)\n* Immunosuppressant regimen not containing tacrolimus immediate release product\n* Known hypersensitivity to tacrolimus and\u002For its formulation.","ALL","1 Year","18 Years",{"count":87,"type":88},45,"ESTIMATED","INTERVENTIONAL",[91],"PHASE4","This study aims to evaluate the efficacy of genotype-informed Bayesian dosing of tacrolimus in optimising drug exposure among paediatric solid organ transplant recipients. By tailoring tacrolimus dosage based on individual genetic makeup and using Bayesian modeling to predict drug levels, the researchers hope to increase the likelihood of achieving therapeutic drug concentrations while minimising the risk of adverse events associated with subtherapeutic or supratherapeutic exposure.",[94],"Solid Organ Transplant",[30,96,97,98],"Pharmacogenomics","Bayesian","Paediatrics","2026-02-22",{"date":101,"type":102},"2026-02-25","ACTUAL",{"date":104,"type":102},"2024-08-05",{"date":106,"type":88},"2027-08-02",{"name":5,"class":6},1]