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.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 240 (estimated)
• Sponsor: Chiesi España, S.A.U. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Trasplant
• Lung Transplantation

Timeline

• Start date: 2024-10-29
• Primary completion: 2026-10-29
• Completion: 2026-12-31
• First posted: 2025-06-27
• Last updated: 2025-06-27

Locations

2 sites across 1 country: Spain