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

• Status: Recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington D.C. Veterans Affairs Medical Center
• Collaborator: Boehringer Ingelheim
• Treatments: Empagliflozin

Criteria

Inclusion Criteria:

1. African American veterans

2. Age > 18 years

3. Stages 2 -3 CKD (eGFR ≥30-89 mL/min/1.73 m2 by the CKD-EPI equation)

4. Albuminuria of 30 mg/g or higher

5. BMI=25-39.9

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 aberrations in glycemic control)

7. Women who are pregnant, planning to become pregnant, nursing mothers, women of childbearing potential not using birth control measure

8. Hypersensitivity to empagliflozin or any of the excipients in Jardiance, reactions such as angioedema

9. Patients on dialysis

10. Stage 4-5 CKD defined as an eGFR < 30 mL/min/1.73 m2 by the CKD-EPI equation

11. Planned surgery or planned hospital admission within 5 months of participation in the study

12. 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)

13. Patients with known h/o psychiatric illness.

14. Patients with prior history of diagnosis of heart failure with documented EF of less than 50.

15. Proven diagnosis of Polycystic Kidney Disease.