Status:
NOT_YET_RECRUITING
Role of Finerenone in African American Veterans With Diabetic Kidney Disease
Lead Sponsor:
Washington D.C. Veterans Affairs Medical Center
Collaborating Sponsors:
Bayer
Conditions:
Diabetic Kidney Disease
Eligibility:
All Genders
20-90 years
Phase:
PHASE4
Brief Summary
Primary Objectives: To study podocyte specific injury markers (podocyte specific proteins, PSP) nephrin, podocalyxin and Wilms'Tumor (WT-1) protein in exosomes urine from African American Veterans wit...
Detailed Description
Chronic kidney disease (CKD) is a complex medical condition imposing deleterious effects on multiple organ systems. Prevention of increased cardiovascular mortality and progression to end-stage kidney...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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%)
- African American veterans
- Age 20-90 years
- eGFR ≥25-89 mL/min/1.73 m2 by the CKD-EPI equation)
- Albuminuria of 30 mg/g or higher
- BMI=18-39.9
- Blood pressure controlled to ≤140/90
- Ability to provide informed consent before any trial related activities are conducted.
- Exclusion Criteria
- If a patient is on statin, need to be on a stable dose for a month.
- Biopsy proven diagnosis of glomerular disease/glomerulonephritis
- Active smokers,
- Active skin wounds undergoing treatment or recent surgery within 1 month (due to possible aberrations in glycemic control)
- Women who are pregnant, planning to become pregnant, nursing mothers, women of childbearing potential not using birth control measure
- Hypersensitivity to empagliflozin or finerenone
- Patients on dialysis
- eGFR less than 25 mL/min/1.73 m2 by the CKD-EPI equation
- Planned surgery or planned hospital admission within 5 months of participation in the study
- 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)
- Patients with prior history of diagnosis of heart failure with documented EF of less than 50.
- Proven diagnosis of Polycystic Kidney Disease.
Exclusion
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07155694
Start Date
September 1 2025
End Date
August 1 2027
Last Update
September 4 2025
Active Locations (1)
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1
Washington DC Veterans Affairs Medical Center (688)
Washington D.C., District of Columbia, United States, 20422