Tacrolimus Melt-Dose® for people after a lung transplant
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.
This study will test how a once-daily Melt-Dose® tacrolimus (LCPT) is processed in the body and how safe it is for adults who recently had a unilateral or bilateral lung transplant over 12 months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chiesi España, S.A.U. Academic / other |
| Locations | 2 sites (L'Hospitalet de Llobregat, Barcelona and 1 other locations) |
| Trial ID | NCT07042035 on ClinicalTrials.gov |
What this trial studies
This is an observational, real-world study following adult patients who start once-daily LCPT within three months after their first unilateral or bilateral lung transplant. Researchers will collect pharmacokinetic data and routine clinical safety information during usual care and monitor participants for 12 months. No experimental interventions are assigned; dosing follows the treating physician's usual practice while blood levels and adverse events are recorded. The goal is to characterize tacrolimus metabolism and safety profiles in this lung transplant population.
Who should consider this trial
Good fit: Adults (≥18 years) who received their first unilateral or bilateral lung transplant, began once-daily LCPT within three months post-transplant, expect to continue treatment for at least 12 months, and can provide informed consent.
Not a fit: Patients with prior or multi-organ transplants, limited life expectancy (<12 months), cystic fibrosis, scleroderma, systemic digestive disease, or other conditions/treatments that interfere with participation are unlikely to benefit from the study findings.
Why it matters
Potential benefit: If successful, the findings could help clinicians choose and dose LCPT more precisely to reduce side effects or underexposure after lung transplant.
How similar studies have performed: Extended-release MeltDose/LCPT formulations have shown improved pharmacokinetics in other solid-organ transplants, but evidence specifically in lung transplant recipients is limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
L'Hospitalet de Llobregat, Barcelona and 1 other locations
- Chiesi España, Torre Realia BCN Plaza Europa 41-43 — L'Hospitalet de Llobregat, Barcelona, Spain (Recruiting)
- Hospital Universitario 12 de Octubre — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Peral Roddriguez
- Email: m.peral@chiesi.com
- Phone: +34 663 0205 12
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.