Tacrolimus Melt-Dose® for people after a lung transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Muscle health before and after lung transplant in adults

  This study tests how respiratory and leg muscle health relates to physical function and recovery in adults awaiting and after lung transplantation.

  Recruiting University of Florida · Gainesville, Florida · NCT07747337

• Prediction score for death or lung transplant in emphysema caused by alpha-1 antitrypsin deficiency

  This study tests a new prediction tool to identify people with emphysema due to alpha-1-antitrypsin deficiency who are at high risk of death or needing a lung transplant.

  Recruiting at 4 sites University Hospital, Bordeaux · Bron and 3 other locations · NCT07715617

• Long-term health of children born to mothers who had a solid organ transplant

  This project will look for long-term heart, kidney, and immune system problems in people aged 16 and older who were born to mothers who had a kidney, liver, pancreas, heart, or lung transplant.

  Recruiting University Medical Center Groningen · Groningen, Provincie Groningen · NCT07291258

• Aerobic versus high-intensity interval exercise for people awaiting lung transplant

  This trial tests whether short bursts of high-intensity interval training or longer moderate aerobic sessions better improve walking distance and daily function for people with interstitial lung disease who are on the lung transplant waiting list.

  Recruiting Ankara City Hospital Bilkent · Ankara · NCT07065318

• Fostamatinib to see if it’s safe for lung transplant patients with donor-specific antibodies

  This trial tests whether taking fostamatinib is safe for adults who have donor-specific antibodies after a lung transplant.

  Recruiting at 4 sites Phase 1 National Institutes of Health Clinical Center (CC) · Stanford, California and 3 other locations · NCT06948097

• LMWH versus UFH for ECMO anticoagulation during bilateral lung transplant

  This will see if low-molecular-weight heparin (enoxaparin) works as a safe and effective alternative to unfractionated heparin for blood thinning during ECMO around bilateral lung transplantation.

  Recruiting University Hospital, Motol · Prague, Czech Republic · NCT06868823

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.