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 @ 4:42 AM
Ignite Modification Date:
2025-12-25 @ 4:42 AM
NCT ID:
NCT02647918
Eligibility Criteria:
Inclusion Criteria:
* Adult male and female subjects ≥18 to ≤75 years of age
* Body mass index ≥18.0 to ≤36.0 kg/m2, at Screening
* Subjects with mild, moderate, or severe renal impairment, or ESRD requiring HD
* Control group of matched healthy subjects
* Willing and able to provide written informed consent
Exclusion Criteria:
* Presence of clinically significant physical, laboratory, or ECG findings that may interfere with any aspect of study conduct or interpretation of results
* Existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism, or excretion of sotagliflozin
* History of any major surgery within 6 months
* History of hepatic disease, or significantly abnormal liver function test
* Women who are breastfeeding or are planning to become pregnant during the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02647918
Study Brief:
Protocol Section:
NCT02647918