Effect of Empagliflozin on Podocyte Specific Proteins (Injury Markers) in African American Veterans With Non-Diabetic Chronic Kidney Disease
Washington D.C. Veterans Affairs Medical Center
Summary
Primary Objective:To study podocyte specific injury markers in African American Veterans with non-diabetic kidney disease(NDKD), on empagliflozin therapy. Primary Endpoint: 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 Objective: 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. 3. Correlate urine podocyte-specific protein markers with APOL1 mRNA expression levels in blood mononuclear cells (MNC)
Description
Nephropathy is a progressive complication of DKD and NDKD and substantially increases morbidity and mortality. Clinicians frequently measure proteinuria using urine protein /creatinine and urine albumin/creatinine ratios, which in several instances do not manifest substantial improvement, even after an intervention such as SGLT2i, particularly if the intervention period is is less than 6 months. There is therefore a clear need for other markers of podocyte injury in early phases of chronic kidney disease. Based on published studies, podocyte-specific injury proteins such as podocalyxin, Nephr…
Eligibility
- Age range
- 19–90 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugEmpagliflozin 10 MG
Take Empagliflozin 10 mg orally daily for 4 months
- DrugPlacebo
Take Placebo 10 mg orally daily for 4 months
Location
- Washington DC Veterans Affairs Medical Center (688)Washington D.C., District of Columbia