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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT07155694
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of type 2 diabetes (HbA1C at or above 6.5%, or fasting blood glucose of more than 125 or random/ post prandial blood glucose of more than 199mg%)
2. African American veterans
3. Age 20-90 years
4. eGFR ≥25-89 mL/min/1.73 m2 by the CKD-EPI equation)
5. Albuminuria of 30 mg/g or higher
6. BMI=18-39.9
7. Blood pressure controlled to ≤140/90
8. Ability to provide informed consent before any trial related activities are conducted.
Exclusion Criteria
1. If a patient is on statin, need to be on a stable dose for a month.
2. Biopsy proven diagnosis of glomerular disease/glomerulonephritis
3. Active smokers,
4. Active skin wounds undergoing treatment or recent surgery within 1 month (due to possible aberrations in glycemic control)
5. Women who are pregnant, planning to become pregnant, nursing mothers, women of childbearing potential not using birth control measure
6. Hypersensitivity to empagliflozin or finerenone
7. Patients on dialysis
8. eGFR less than 25 mL/min/1.73 m2 by the CKD-EPI equation
9. Planned surgery or planned hospital admission within 5 months of participation in the study
10. At the discretion of PI to ensure health, safety, and well-being of the veteran, participation in this study may be stopped (please see withdrawal criteria)
11. Patients with prior history of diagnosis of heart failure with documented EF of less than 50.
12. Proven diagnosis of Polycystic Kidney Disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
90 Years
Study:
NCT07155694
Study Brief:
Protocol Section:
NCT07155694