About this trial
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).
Eligibility criteria
Qualifiers
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)
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Finerenone 10 MG
- Empagliflozin 10 MG
Treatment groups
Sponsors and collaborators
Washington D.C. Veterans Affairs Medical Center
Lead sponsor
Bayer
Collaborator