Study of Tacrolimus Melt-Dose® for Lung Transplant Patients
Recruiting now
Conditions studied: Lung Trasplant, Lung Transplantation
In brief
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.
Key facts
- Study ID
- NCT07042035
- Run by
- Chiesi España, S.A.U.
- People needed
- 240
- Starts
- 2024-10-29
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2025-06-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Chiesi España, Torre Realia BCN Plaza Europa 41-43 — L'Hospitalet de Llobregat, Barcelona, Spain (enrolling)
- Hospital Universitario 12 de Octubre — Madrid, Spain (enrolling)
Full record on ClinicalTrials.gov
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