Actively Recruiting
Pharmacokinetic Study, Effectiveness, and Safety of the Tacrolimus Formulation Based on Melt-Dose ae Technology (LCPT) as an Immunosuppressive Treatment for Lung Transplant Patients Under Usual Clinical Practice Conditions
Led by Chiesi España, S.A.U. · Updated on 2025-06-27
240
Participants Needed
2
Research Sites
9 weeks
Total Duration
On this page
Sponsors
C
Chiesi España, S.A.U.
Lead Sponsor
T
Trialance SCCL
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to study the pharmacokinetics and safety of tacrolimus in a specific formulation called LCPT, used as immunosuppressive treatment for patients who have recently undergone unilateral or bilateral lung transplantation. The study observes how tacrolimus is metabolized and its clinical effects over a one-year follow-up period under usual clinical conditions. Participants are those who have started oral tacrolimus with the LCPT formulation within the first three months after lung transplant, taking it once daily. The study monitors patients for at least 12 months while they continue their treatment as part of routine care. During the study, researchers will evaluate key pharmacokinetic parameters of tacrolimus, clinical effectiveness including acute rejection episodes, lung function via spirometry, kidney function measured by glomerular filtration rate, common complications after lung transplant, and any adverse events. The total participation duration is one year from treatment start, with ongoing safety and effectiveness assessments.
CONDITIONS
Brief Title
Study of Tacrolimus Melt-Dose® for Lung Transplant Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years old or older
- Patients who have received their first unilateral or bilateral lung transplant
- Patients who have started oral tacrolimus treatment with the LCPT formulation once daily within the first 3 months after transplant
- Patients expected to continue treatment for at least 12 months
- Patients or their representatives able to sign informed consent to participate
You will not qualify if you...
- Patients who have received a multi-organ transplant or have a history of any organ transplant including lung
- Patients with an estimated survival of less than 12 months
- Patients diagnosed with cystic fibrosis
- Patients diagnosed with scleroderma
- Patients diagnosed with systemic diseases affecting the digestive system
- Patients in any condition that the investigator considers unsuitable for participation, including interfering treatments
- Patients participating or having participated in an interventional study within 30 days prior to inclusion
- Pregnant women, those planning pregnancy, or breastfeeding
- Patients unable to complete the study
- Patients who have not signed informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 year
Participants who have started oral tacrolimus treatment are monitored to assess pharmacokinetic parameters, clinical effectiveness, lung and renal function, complications, and adverse events.
Trial Site Locations
Total: 2 locations
1
Chiesi España, Torre Realia BCN Plaza Europa 41-43
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Actively Recruiting
2
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
Research Team
P
Peral Roddriguez
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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