Study of Tacrolimus Melt-Dose LCPT as an Immunosuppressive Treatment for Adults After Lung Transplant with 12-Month Follow-Up

What this Trial Is About

This research aims to study the pharmacokinetics and safety of tacrolimus in a specific formulation called LCPT, used as immunosuppressive treatment for patients who have recently undergone unilateral or bilateral lung transplantation. The study observes how tacrolimus is metabolized and its clinical effects over a one-year follow-up period under usual clinical conditions. Participants are those who have started oral tacrolimus with the LCPT formulation within the first three months after lung transplant, taking it once daily. The study monitors patients for at least 12 months while they continue their treatment as part of routine care. During the study, researchers will evaluate key pharmacokinetic parameters of tacrolimus, clinical effectiveness including acute rejection episodes, lung function via spirometry, kidney function measured by glomerular filtration rate, common complications after lung transplant, and any adverse events. The total participation duration is one year from treatment start, with ongoing safety and effectiveness assessments.

Study of Tacrolimus Melt-Dose® for Lung Transplant Patients