Washington D.C. Veterans Affairs Medical Center
Primary Objective: To study podocyte specific injury markers in African American Veterans with non-diabetic kidney disease (NDKD), on empagliflozin therapy. Primary Endpoint: We will assess the effect of Empagliflozin on podocyte-specific proteins in exosomes isolated from subjects' urine, such as nephrin, podocalyxin and Wilms'Tumor (WT-1) protein. Secondary Objectives: 1. Correlate changes in exosome-based podocyte specific proteins with standardized biomarkers of kidney injury including urine albumin/creatinine ratio (ACR) and estimated GFR. 2. Correlate systemic inflammatory markers (focusing on vascular and endothelial function) that are already established such as interleukins (IL1, IL6, IL-12) , hs-CRP and arterial stiffness measures with urine exosome-based podocyte protein estimation \[11, 27-29\]. 3. Correlate urine podocyte-specific protein markers with APOL1 mRNA expression levels in blood mononuclear cells (MNC)
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 \[1\]. In patients with Non-Diabetic Kidney Disease (NDKD), the cornerstone of management includes blood pressure control, maintenance of normal body weight, dietary adherence, and avoidance of nephrotoxic drugs \[2,3\]. The management of diabetic kidney…
Inclusion Criteria: 1. African American veterans 2. Age \> 18 years 3. eGFR ≥20-59 mL/min/1.73 m2 by the CKD-EPI equation, with or without any degree of albuminuria OR 4. eGFR 60-89, with UACR of ≥30mg/g 5. BMI = 18-39.9 6. Blood pressure controlled to ≤140/90 7. Subjects without diabetes: will be screened using routine glucose level test: of less than 126 fasting glucose or less than 200mg/dl of random or post glucose blood glucose level in standard of care laboratory workup. 8. Ability to provide informed consent before any trial related activities are conducted. Exclusion Criteria: 1. Di…
Take Empagliflozin 10 mg orally daily for 4 months
Take Placebo 10 mg orally daily for 4 months
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