RecruitingPhase 4NCT06110130

Effect of Empagliflozin on Podocyte Specific Proteins in African American Veterans With NDKD

Effect of Empagliflozin on Podocyte Specific Proteins (Injury Markers) in African American Veterans With Non-Diabetic Chronic Kidney Disease

Sponsor

Washington D.C. Veterans Affairs Medical Center

Enrollment

60 participants

Start Date

Feb 2, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Kidney Diseases

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)

Eligibility

Min Age: 19 YearsMax Age: 90 Years

Inclusion Criteria8

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
BMI = 18-39.9
Blood pressure controlled to ≤140/90
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.
Ability to provide informed consent before any trial related activities are conducted.

Exclusion Criteria14

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
Active smokers,
Active skin wounds undergoing treatment or recent surgery within 1 month (due to possible aberrations in glycemic control)
Women who are pregnant, planning to become pregnant, nursing mothers, women of childbearing potential not using birth control measure
Hypersensitivity to empagliflozin or any of the excipients in Jardiance, reactions such as angioedema
Patients on dialysis
eGFR less than 20 mL/min/1.73 m2 by the CKD-EPI equation
Planned surgery or planned hospital admission within 5 months of participation in the study
At the discretion of PI to ensure health, safety, and well-being of the veteran, participation in this study may be stopped (please see withdrawal criteria)
Patients with prior history of diagnosis of heart failure with documented EF of less than 50.
Proven diagnosis of Polycystic Kidney Disease.