[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596175":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":7,"centralContacts":8,"locations":14,"responsibleParty":47,"collaborators":49,"id":53,"slug":7,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":7,"enrollmentInfo":62,"targetDuration":7,"studyType":65,"phases":7,"briefSummary":66,"conditions":67,"keywords":7,"overallStatus":17,"whyStopped":7,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"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",[15,32],{"facility":16,"status":17,"city":18,"state":19,"zip":20,"country":21,"cosmosGeoPoint":22,"geoPoint":27,"contacts":28},"Chiesi España, Torre Realia BCN Plaza Europa 41-43","RECRUITING","L'Hospitalet de Llobregat","Barcelona","08908","Spain",{"type":23,"coordinates":24},"Point",[25,26],2.10028,41.35967,{"lat":26,"lon":25},[29],{"name":30,"role":11,"phone":31,"phoneExt":7,"email":13},"Peral Rodríguez","+34 663020512",{"facility":33,"status":17,"city":34,"state":7,"zip":35,"country":21,"cosmosGeoPoint":36,"geoPoint":40,"contacts":41},"Hospital Universitario 12 de Octubre","Madrid","28041",{"type":23,"coordinates":37},[38,39],-3.70256,40.4165,{"lat":39,"lon":38},[42,45],{"name":43,"role":11,"phone":7,"phoneExt":7,"email":44},"Alicia de Pablo de Pablo, MhD","alic1575@separ.es",{"name":43,"role":46,"phone":7,"phoneExt":7,"email":7},"PRINCIPAL_INVESTIGATOR",{"type":48,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[50],{"name":51,"class":52},"Trialance SCCL","INDUSTRY","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":63,"type":64},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.",[68,69],"Lung Trasplant","Lung Transplantation","2025-06-25",{"date":72,"type":73},"2025-06-27","ACTUAL",{"date":75,"type":73},"2024-10-29",{"date":77,"type":64},"2026-12-31",{"name":5,"class":6},2]