Impact of Empagliflozin on Kidney Health in African American Veterans

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.