drugset / Trial / NCT06110130

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

NCT06110130

RandomizedParallel-groupQuadruple-blindTreatment

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)

Timeline

Start
2024-02-02
Primary completion
2027-12-01
Completion
2028-12-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Empagliflozin Small molecule 10 mg Oral