[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596175":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":7,"centralContacts":8,"locations":14,"responsibleParty":48,"collaborators":50,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":7,"enrollmentInfo":64,"targetDuration":7,"studyType":67,"phases":7,"briefSummary":68,"conditions":69,"keywords":7,"overallStatus":17,"whyStopped":7,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Chiesi España, S.A.U.","OTHER",null,[9],{"name":10,"role":11,"phone":12,"phoneExt":7,"email":13},"Peral Roddriguez","CONTACT","+34 663 0205 12","m.peral@chiesi.com",[15,33],{"facility":16,"status":17,"city":18,"state":19,"zip":20,"country":21,"countryCode":22,"cosmosGeoPoint":23,"geoPoint":28,"contacts":29},"Chiesi España, Torre Realia BCN Plaza Europa 41-43","RECRUITING","L'Hospitalet de Llobregat","Barcelona","08908","Spain","ES",{"type":24,"coordinates":25},"Point",[26,27],2.10028,41.35967,{"lat":27,"lon":26},[30],{"name":31,"role":11,"phone":32,"phoneExt":7,"email":13},"Peral Rodríguez","+34 663020512",{"facility":34,"status":17,"city":35,"state":7,"zip":36,"country":21,"countryCode":22,"cosmosGeoPoint":37,"geoPoint":41,"contacts":42},"Hospital Universitario 12 de Octubre","Madrid","28041",{"type":24,"coordinates":38},[39,40],-3.70256,40.4165,{"lat":40,"lon":39},[43,46],{"name":44,"role":11,"phone":7,"phoneExt":7,"email":45},"Alicia de Pablo de Pablo, MhD","alic1575@separ.es",{"name":44,"role":47,"phone":7,"phoneExt":7,"email":7},"PRINCIPAL_INVESTIGATOR",{"type":49,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[51],{"name":52,"class":53},"Trialance SCCL","INDUSTRY","100596175","study-of-tacrolimus-melt-dose-for-lung-transplant-patients-100596175",false,"NCT07042035","Study of Tacrolimus Melt-Dose® for Lung Transplant Patients","Pharmacokinetic Study, Effectiveness, and Safety of the Tacrolimus Formulation Based on Melt-Dose® Technology (LCPT) as an Immunosuppressive Treatment for Lung Transplant Patients, Under Usual Clinical Practice Conditions.","ESENCIAL","Inclusion Criteria:\n\n* Patients ≥18 years old.\n* Patients who have received a first unilateral or bilateral lung transplant.\n* Patients who have started oral treatment with tacrolimus using the LCPT formulation, with a once-daily dosage within the first 3 months post-transplant.\n* Patients with a treatment duration expected to be ≥12 months.\n* The patient (or their representative) can sign the informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Patients who have received a multi-organ transplant or have a history of any organ transplant, including lung.\n* Patients with an estimated survival of \\\u003C12 months\n* Patients diagnosed with cystic fibrosis\n* Patients diagnosed with scleroderma.\n* Patients diagnosed with a systemic disease affecting the digestive system.\n* Patients in any situation or condition that, in the investigator's opinion, makes participation inadvisable, such as any treatment that may interfere with the study.\n* Patients who are participating or have participated in an interventional research study within 30 days prior to inclusion.\n* Pregnant women, those planning to become pregnant, or those who are breastfeeding.\n* Patients who are unable to complete the study.\n* Patients who have not signed the informed consent.","ALL","18 Years",{"count":65,"type":66},240,"ESTIMATED","OBSERVATIONAL","To evaluate, under usual clinical practice conditions and with a 12-month follow-up , the most relevant pharmacokinetic parameters of tacrolimus metabolism and safety, in patients with recent lung transplant (unilateral or bilateral) treated with LCPT.",[70,71],"Lung Trasplant","Lung Transplantation","2025-06-25",{"date":74,"type":75},"2025-06-27","ACTUAL",{"date":77,"type":75},"2024-10-29",{"date":79,"type":66},"2026-12-31",{"name":5,"class":6},2]