Study of Tacrolimus Melt-Dose® for Lung Transplant Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Lung Trasplant, Lung Transplantation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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.
Overview
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.
Primary outcome measures
- To evaluate the most relevant pharmacokinetic parameters of tacrolimus metabolism and their relationship with clinical effectiveness and safety . [Time frame: 1 year of follow up]
Secondary outcome measures (6)
- To assess the pharmacokinetic parameters of LCPT ( concentration/dose ratio (C/D)). [Time frame: 1 year]
- To assess clinical effectiveness (acute rejection). [Time frame: 1 year]
- To assess lung function (spirometry). [Time frame: 1 year]
- To assess renal function (glomerular flow rate). [Time frame: 1 year]
- To assess the most frequent complications in lung transplant. [Time frame: 1 year]
- To assess adverse events. [Time frame: 1 year]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 2 centers
- Chiesi España, Torre Realia BCN Plaza Europa 41-43 — L'Hospitalet de Llobregat
- Hospital Universitario 12 de Octubre — Madrid
Identifiers
NCT: NCT07042035 · CHI-TAC-2024-01