Study of Tacrolimus Melt-Dose® for Lung Transplant Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChiesi España, S.A.U.
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Chiesi España, S.A.U.
Lead sponsor
Trialance SCCL
Collaborator
Source ClinicalTrials.gov