Actively Recruiting
Effect of Empagliflozin on Podocyte Specific Proteins in African American Veterans With NDKD
Led by Washington D.C. Veterans Affairs Medical Center · Updated on 2025-07-20
60
Participants Needed
1
Research Sites
252 weeks
Total Duration
On this page
Sponsors
W
Washington D.C. Veterans Affairs Medical Center
Lead Sponsor
B
Boehringer Ingelheim
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Effect of Empagliflozin on Podocyte Specific Proteins in African American Veterans With NDKD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- African American veterans
- Age over 18 years
- eGFR between 20-59 mL/min/1.73 m2 with or without albuminuria, OR eGFR 60-89 with urine albumin/creatinine ratio of 30 mg/g or higher
- Body mass index (BMI) between 18 and 39.9
- Blood pressure controlled to 140/90 mmHg or lower
- No diabetes, confirmed by fasting glucose less than 126 mg/dL or random/post-glucose blood glucose less than 200 mg/dL
- Ability to provide informed consent before any trial activities
You will not qualify if you...
- Diagnosed with type 1 or type 2 diabetes mellitus
- Use of diabetes medications such as GLP1 receptor agonists, SGLT2 inhibitors, or sulphonylureas
- Statin use without stable dosing for at least one month
- Biopsy-proven glomerular disease or glomerulonephritis
- Active smoker
- Active skin wounds under treatment or recent surgery within one month
- Women who are pregnant, planning pregnancy, nursing, or of childbearing potential not using birth control
- Allergic reaction to empagliflozin or its components
- Patients on dialysis
- eGFR less than 20 mL/min/1.73 m2
- Planned surgery or hospital admission within five months
- History of heart failure with ejection fraction less than 50%
- Diagnosis of polycystic kidney disease
- Participation may be stopped at investigator's discretion for health and safety reasons
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Washington DC Veterans Affairs Medical Center (688)
Washington D.C., District of Columbia, United States, 20422
Actively Recruiting
Research Team
S
Sabyasachi Sen, MD
CONTACT
S
Shannen Ubalde, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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