Actively Recruiting
Study of Tacrolimus Melt-Dose® for Lung Transplant Patients
Led by Chiesi España, S.A.U. · Updated on 2025-06-27
240
Participants Needed
2
Research Sites
113 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
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.
CONDITIONS
Official Title
Study of Tacrolimus Melt-Dose® for Lung Transplant Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older
- Patients who have received a first unilateral or bilateral lung transplant
- Patients who started oral tacrolimus treatment with the LCPT formulation once daily within the first 3 months post-transplant
- Patients expected to continue treatment for at least 12 months
- Patients or their representatives able to provide informed consent
You will not qualify if you...
- Patients who have received multi-organ or any other organ transplant previously
- 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 conditions deemed unsuitable for participation by the investigator
- Patients involved in interventional research studies 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
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
CONTACT
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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