NCT06110130 Effect of Empagliflozin on Podocyte Specific Proteins in African American Veterans With NDKD
| NCT ID | NCT06110130 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Washington D.C. Veterans Affairs Medical Center |
| Condition | Chronic Kidney Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-02-02 |
| Primary Completion | 2027-12-01 |
Trial Parameters
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Brief 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 Criteria
Inclusion Criteria: 1. African American veterans 2. Age \> 18 years 3. eGFR ≥20-59 mL/min/1.73 m2 by the CKD-EPI equation, with or without any degree of albuminuria OR 4. eGFR 60-89, with UACR of ≥30mg/g 5. BMI = 18-39.9 6. Blood pressure controlled to ≤140/90 7. 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. 8. Ability to provide informed consent before any trial related activities are conducted. Exclusion Criteria: 1. Diagnosed with Type 1 or Type 2 Diabetes Mellitus 2. Any prescribed diabetes medication for patients, such as GLP1RA, SGLT2is, and sulphonylureas 3. If a patient is on statin, need to be on a stable dose for a month. 4. Biopsy proven diagnosis of glomerular disease/glomerulonephritis 5. Active smokers, 6. Active skin wounds undergoing treatment or recent surgery within 1 month (due to possible aberrati
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