NCT07042035 Study of Tacrolimus Melt-Dose® for Lung Transplant Patients
| NCT ID | NCT07042035 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chiesi España, S.A.U. |
| Condition | Lung Trasplant |
| Study Type | OBSERVATIONAL |
| Enrollment | 240 participants |
| Start Date | 2024-10-29 |
| Primary Completion | 2026-10-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 240 participants in total. It began in 2024-10-29 with a primary completion date of 2026-10-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07042035 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Trasplant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07042035 currently recruiting?
Yes, NCT07042035 is actively recruiting participants. Contact the research team at m.peral@chiesi.com for enrollment information.
Where is the NCT07042035 trial being conducted?
This trial is being conducted at L'Hospitalet de Llobregat, Spain, Madrid, Spain.
Who is sponsoring the NCT07042035 clinical trial?
NCT07042035 is sponsored by Chiesi España, S.A.U.. The trial plans to enroll 240 participants.