RecruitingNCT07042035

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.

Sponsor

Chiesi España, S.A.U.

Enrollment

240 participants

Start Date

Oct 29, 2024

Study Type

OBSERVATIONAL

Conditions

Lung Trasplant Lung transplantation

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

Patients ≥18 years old.
Patients who have received a first unilateral or bilateral lung transplant.
Patients who have started oral treatment with tacrolimus using the LCPT formulation, with a once-daily dosage within the first 3 months post-transplant.
Patients with a treatment duration expected to be ≥12 months.
The patient (or their representative) can sign the informed consent to participate in the study.

Exclusion Criteria10

Patients who have received a multi-organ transplant or have a history of any organ transplant, including lung.
Patients with an estimated survival of <12 months
Patients diagnosed with cystic fibrosis
Patients diagnosed with scleroderma.
Patients diagnosed with a systemic disease affecting the digestive system.
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.
Patients who are participating or have participated in an interventional research study within 30 days prior to inclusion.
Pregnant women, those planning to become pregnant, or those who are breastfeeding.
Patients who are unable to complete the study.
Patients who have not signed the informed consent.