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)
African American veterans
Age > 18 years
eGFR ≥20-59 mL/min/1.73 m2 by the CKD-EPI equation, with or without any degree of albuminuria OR
eGFR 60-89, with UACR of ≥30mg/g
Diagnosed with Type 1 or Type 2 Diabetes Mellitus
Any prescribed diabetes medication for patients, such as GLP1RA, SGLT2is, and sulphonylureas
If a patient is on statin, need to be on a stable dose for a month.
Biopsy proven diagnosis of glomerular disease/glomerulonephritis
Parallel
Empagliflozin 10 MG
DrugTake Empagliflozin 10 mg orally daily for 4 months
Placebo
DrugTake Placebo 10 mg orally daily for 4 months
To study kidney dysfunction and podocyte specific injury
To study kidney dysfunction and podocyte specific injury in African American Veterans with Non-diabetic kidney disease, following low dose of Empagliflozin therapy. Empagliflozin may be referred to as "Empa" hereafter. Correlate changes in exosome-based podocyte specific proteins with standardized biomarkers of kidney injury including urine albumin/creatinine ratio (ACR) and estimated GFR.
Systemic inflammatory markers
Correlate systemic inflammatory markers (focusing on vascular function and endothelium) that are already established such as interleukins and hs-CRP and arterial stiffness with urine exosome-based podocyte protein estimation To correlate urine podocyte-specific protein markers and serum inflammatory markers with APOL1 mRNA expression levels in blood mononuclear cells (MNC) (c-kit positive cells)
Click on the lead sponsor to view all of their trials.
Washington D.C. Veterans Affairs Medical Center
Lead sponsor
Boehringer Ingelheim
Collaborator
