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 @ 1:17 PM
Ignite Modification Date:
2025-12-24 @ 1:17 PM
NCT ID:
NCT04420195
Eligibility Criteria:
Inclusion Criteria:
Prospective arm:
* Age ≥ 18 years
* Received a lung transplant at NYU Langone Health
* Be able to convert to Envarsus XR within the first month post-transplant
* Able and willing to provide informed consent
Historical control:
* Age ≥ 18 years
* Received a lung transplant at NYU Langone Health
* Completed one year from transplant on IR tacrolimus
Exclusion Criteria:
Prospective arm:
* Contraindication to tacrolimus due to allergic or adverse reactions
* Pregnant or nursing women
* Multi-organ transplant recipient
Historical control:
* Contraindication to tacrolimus due to allergic or adverse reactions (not including chronic kidney disease)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04420195
Study Brief:
Protocol Section:
NCT04420195