Impact of Empagliflozin on Kidney Health in African American Veterans
Effect of Empagliflozin on Podocyte Specific Proteins (Injury Markers) in African American Veterans With Non-Diabetic Chronic Kidney Disease
This study is testing if empagliflozin can help protect kidney health in African American veterans with non-diabetic kidney disease by looking at certain proteins in their urine.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 19 Years to 90 Years |
| Sex | All |
| Sponsor | Washington D.C. Veterans Affairs Medical Center Federal |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT06110130 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of empagliflozin on specific proteins related to podocyte injury in African American veterans suffering from non-diabetic kidney disease. It aims to assess changes in urinary exosome-based podocyte proteins, such as nephrin and podocalyxin, and correlate these changes with established kidney injury biomarkers and systemic inflammatory markers. The study seeks to provide a non-invasive method for detecting early kidney damage, potentially reducing the need for invasive biopsies. By focusing on a specific population, it aims to enhance understanding of kidney disease mechanisms and improve treatment strategies.
Who should consider this trial
Good fit: Ideal candidates include African American veterans aged over 18 with stages 2-3 chronic kidney disease and specific albuminuria levels.
Not a fit: Patients with diagnosed diabetes or those on diabetes medications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and management of kidney disease in African American veterans.
How similar studies have performed: Previous studies have shown promise in using urinary exosome analysis for kidney disease, but this specific approach in the targeted population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 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. eGFR less than 20 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 prior history of diagnosis of heart failure with documented EF of less than 50. 14. Proven diagnosis of Polycystic Kidney Disease.
Where this trial is running
Washington D.C., District of Columbia
- Washington DC Veterans Affairs Medical Center (688) — Washington D.C., District of Columbia, United States (Recruiting)
Study contacts
- Principal investigator: Sabyasachi Sen, MD — Washington VA Medical Center
- Study coordinator: Sabyasachi Sen, MD
- Email: sabyasachi.sen@va.gov
- Phone: 202-745-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.