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:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT03978494
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients aged ≥18 years;
* Patients with a Body Mass Index (BMI) included in the interval \[18.5-33.0\] kg/m²;
* Patients who received a primary kidney transplant at least 12 months prior to study entry
Exclusion Criteria:
* Evidence or suspicion of ongoing or persistent, acute or chronic rejection;
* Requirement for dialysis within the six months prior to study entry;
* Glomerular filtration rate (GFR) \<30 mL/min
* Pregnant or breastfeeding women, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test;
* Intolerance to tacrolimus, excipients (including lactose, fructose or galactose), or similar products;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03978494
Study Brief:
Protocol Section:
NCT03978494