Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-24 @ 10:07 PM
NCT ID:
NCT07042035
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07042035
Study Brief:
Protocol Section:
NCT07042035