[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Chiesi España, S.A.U.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"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":20,"type":21},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.",[25,26],"Lung Trasplant","Lung Transplantation","RECRUITING","2025-06-25",{"date":30,"type":31},"2025-06-27","ACTUAL",{"date":33,"type":31},"2024-10-29",{"date":35,"type":21},"2026-12-31",{"name":37,"class":38},"Chiesi España, S.A.U.","OTHER",2,""]