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

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

Plain Language Summary

Simplified for easier understanding

This study tests whether empagliflozin (Jardiance), a medication originally designed for diabetes, helps protect the kidneys in African American veterans who have chronic kidney disease but do NOT have diabetes. The focus is on a specific type of kidney damage not caused by diabetes (NDKD). **You may be eligible if...** - You are an African American veteran over 18 - You have mild-to-moderate chronic kidney disease (specific eGFR and/or protein-in-urine criteria) - Your blood pressure is controlled to 140/90 or below - You do NOT have diabetes **You may NOT be eligible if...** - You have type 1 or type 2 diabetes, or take any diabetes medications - You have a confirmed glomerular kidney disease (specific kidney inflammation) - You are an active smoker - You are pregnant, planning to become pregnant, or breastfeeding - You have a history of heart failure with reduced pumping function - You have polycystic kidney disease - You are allergic to empagliflozin Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEmpagliflozin 10 MG

Take Empagliflozin 10 mg orally daily for 4 months

DRUGPlacebo

Take Placebo 10 mg orally daily for 4 months


Locations(1)

Washington DC Veterans Affairs Medical Center (688)

Washington D.C., District of Columbia, United States

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NCT06110130


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