Study of Tacrolimus Melt-Dose® for Lung Transplant Patients

Launched by CHIESI ESPAÑA, S.A.U. · Jun 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medicine called Tacrolimus Melt-Dose® (also known as LCPT) in people who have recently received a lung transplant, either one lung or both. The goal is to understand how the body processes this medicine and to check its safety over a year of regular use. Tacrolimus helps prevent the body from rejecting the new lung, and this study wants to see how well the once-daily dose works in real-life settings.

People eligible for this trial are adults who have had their first lung transplant and have started taking this specific form of tacrolimus within three months after surgery. They should plan to continue treatment for at least a year and be able to give consent to participate. The study does not include those with certain health conditions like cystic fibrosis or who have had other organ transplants. Participants will be followed for 12 months to monitor how their body handles the medicine and to make sure it’s safe. This study is currently recruiting patients, and it offers an opportunity to help doctors learn more about improving care for lung transplant patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.