[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570021":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":52,"collaborators":54,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":25,"maxAge":25,"enrollmentInfo":67,"targetDuration":25,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":78,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Instituto de Investigación Hospital Universitario La Paz","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of care","ACTIVE_COMPARATOR","Patients in this control group will receive treatment with any formulation of Tacrolimus authorized and commercialized in Spain. They will be administered tacrolimus according to clinical practice and the drug's product labeling.",[13],"Drug: Tacrolimus",{"label":15,"type":16,"description":17,"interventionNames":18},"Dose adjusted by guidelines","EXPERIMENTAL","Participants in this experimental group will receive treatment with any formulation of Tacrolimus authorized and commercialized in Spain. They will be administered the specific dosage of tacrolimus recommended by the Clinical Pharmacogenetics Consortium's genotype guidelines, utilizing the patient's pharmacogenetic information and characteristics.",[13],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Tacrolimus","Tacrolimus at the dosage reccomended by the \"Clinical Pharmacogenetics Implementation Consortium (CPIC) Guidelines for CYP3A5 Genotype and Tacrolimus Dosing\" based on the subjects pharmacogenetic phenotype.",[9],null,{"type":21,"name":22,"description":27,"armGroupLabels":28,"otherNames":25},"Subject allocated to this arm will receive tacrolimus according to clinical practice and the drug's product labelling. These subject will not receive a personalised dose based on their pharmacogenetic phenotype.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Alberto M. Borobia, MD, PhD","CONTACT","+34 912071466","alberto.borobia@salud.madrid.org",[36],{"facility":37,"status":38,"city":39,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Hospital La Paz","RECRUITING","Madrid","28046","Spain","ES",{"type":44,"coordinates":45},"Point",[46,47],-3.70256,40.4165,{"lat":47,"lon":46},[50],{"name":51,"role":32,"phone":25,"phoneExt":25,"email":25},"Arturo Gomez Lopez de las Huertas, MD",{"type":53,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[55],{"name":56,"class":57},"Instituto de Salud Carlos III","OTHER_GOV","100570021","phase-4-effectiveness-and-cost-effectiveness-of-a-pre-emptive-genotyping-strategy-in-patients-receiving-tacrolimus-100570021",false,"NCT06701825","Effectiveness and Cost-effectiveness of a Pre-emptive Genotyping Strategy in Patients Receiving Tacrolimus","A Multicentre, Controlled, Randomised and Single-blind, Adaptive Phase IV Protocol to Evaluate Effectiveness and Cost-effectiveness of Pre-emptive Genotyping Strategy to Optimise Tacrolimus Dosage in a Pretransplant Chronic Kidney Disease Population Cohort","TRANSPGx","Inclusion Criteria:\n\n1. Participants must be willing and able to provide written informed consent prior the initiation of any study procedures.\n2. Subject or their legally authorized representative has voluntarily signed the informed consent document.\n3. Participant is on the waiting list for a kidney transplant.\n4. Subject is able and willing to take part and be followed-up for the majority of the study duration, and adhere to the procedures specified in this protocol.\n5. Subjects must be naïve to any genotyping test of the following genes: CYP3A5.\n\nExclusion Criteria:\n\n1. Known hypersensitivity\u002Fallergy reaction to tacrolimus or any of the excipients.\n2. History of renal, heart, and\u002For liver transplant.\n3. History or clinical evidence of any disease and\u002For existence of any surgical or medical condition, which might interfere in a relevant manner with the absorption, distribution, metabolism, or excretion of the study treatment, except for renal disease.\n4. Any condition or situation precluding or interfering the compliance with the protocol.\n5. Any condition at medical discretion for which renal transplantation and\u002For study treatment should not be received.","ALL",{"count":68,"type":69},114,"ESTIMATED","INTERVENTIONAL",[72],"PHASE4","This is a phase IV multicentre adaptive single-blinded randomized clinical trial to evaluate if preemptively genotyping populations at pretransplant chronic kidney disease susceptible of receiving tacrolimus therapy is effective, cost-effective, and feasible within the Spanish National Health System when compared to the current standard of care. This trial is nested within the iPHARMGx master protocol.",[75,76,77],"Kidney Disease, Chronic","Transplant Recipient (Kidney)","Immunosuppression",[22,79,80,81,82],"Kidney transplant","Cost-effectiveness","Pharmacogenetic","Phase IV Clinical Trial","2025-09-04",{"date":85,"type":86},"2025-09-11","ACTUAL",{"date":88,"type":86},"2025-06-02",{"date":90,"type":69},"2026-12-31",{"name":5,"class":6},1]