Clinical Trial

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

Study acronym: EMPA CKD
Recruiting Phase 4
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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)
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-10-25; most recent amendment 2025-07-16.
Status change: Not Yet Recruiting → Recruiting 2024-04-10
Trial Details
NCT Number NCT06110130
Lead Sponsor Washington D.C. Veterans Affairs Medical Center
Collaborators: Boehringer Ingelheim
Conditions Chronic Kidney Diseases
Enrollment 60 participants
Start Date 2024-02-02
Primary Completion 2027-12-01 (estimated)
Study Completion 2028-12-01 (estimated)
Updated on ClinicalTrials.gov 2025-07-20