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Study of Tacrolimus Melt-Dose® for Lung Transplant Patients

Study of Tacrolimus Melt-Dose® for Lung Transplant Patients

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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.

Study details
    Lung Trasplant
    Lung Transplantation

NCT07042035

Chiesi España, S.A.U.

15 October 2025

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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