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 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT03436693
Eligibility Criteria:
Inclusion Criteria:
Additional criteria check may apply for qualification:
* Glycated hemoglobin(HbA1c) of ≥6.5% and ≤12.0%
* eGFR of ≥30 mL/min/1.73m2 and \<90 mL/min/1.73m2
* The median UACR of the first morning void urine samples is ≥300 mg/g Cr and ≤5000 mg/g Cr
* Patients who are taking on angiotensin-converting enzyme inhibitor (ACE-I) or angiotensin receptor blocker (ARB)
* Patients who are under dietary management and taking therapeutic exercise for diabetes
Exclusion Criteria:
Additional criteria check may apply for qualification:
* Type I diabetes, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes
* A diagnosis of non-diabetic renal disease
* Hereditary glucose-galactose malabsorption or primary renal glucosuria
* Class IV heart failure symptoms according to New York Heart Association (NYHA) functional classification
* Severe hepatic disorder or severe renal disorder
* Blood potassium level \>5.5 mmoL/L
* Stable blood pressure (diastolic blood pressure (DBP) ≥100mmHg or systolic blood pressure (SBP) ≥180mmHg)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Study:
NCT03436693
Study Brief:
Protocol Section:
NCT03436693