Role of Finerenone in African American Veterans With Diabetic Kidney Disease
Washington D.C. Veterans Affairs Medical Center
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 with albuminuric stage 2 and 3 chronic diabetic kidney disease (DKD), using Empagliflozin or Finerenone or combination therapy. Secondary Objectives: (1). Correlate changes in exosome-based PSP with standardized biomarkers of kidney injury including urine albumin/creatinine ratio (ACR) and estimated GFR. (2) with systemic inflammatory markers (focusing on vascular and endothelial function) that are already established such as interleukins (IL1, IL6, IL-12), hs-CRP and (3) arterial stiffness measures and with (4) APOL1 mRNA expression levels in peripheral blood derived mononuclear cells (MNC).
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 disease (ESKD) are two major unmet medical needs in patients with CKD, with or without diabetes mellitus, especially in those with albuminuria. In patients with Diabetic Kidney Disease (DKD), the cornerstone of management includes blood pressure control, proteinuria management, maintenance of normal body weight, dietary adherence, and avoidance of nephrotoxic drugs. The management of DKD has unde…
Eligibility
- Age range
- 20–90 years
- Sex
- All
- Healthy volunteers
- No
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 dis…
Interventions
- DrugFinerenone 10 MG
Take Finerenone 10 mg orally daily
- DrugEmpagliflozin 10 MG
Take Empagliflozin 10 mg orally daily for 4 months
Location
- Washington DC Veterans Affairs Medical Center (688)Washington D.C., District of Columbia