Status:
RECRUITING
Effect of Empagliflozin on Podocyte Specific Proteins in African American Veterans With NDKD
Lead Sponsor:
Washington D.C. Veterans Affairs Medical Center
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
Chronic Kidney Diseases
Eligibility:
All Genders
19-90 years
Phase:
PHASE4
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 Empag...
Detailed Description
Nephropathy is a progressive complication of DKD and NDKD and substantially increases morbidity and mortality. Clinicians frequently measure proteinuria using urine protein /creatinine and urine album...
Eligibility Criteria
Inclusion
- African American veterans
- Age \> 18 years
- eGFR ≥20-59 mL/min/1.73 m2 by the CKD-EPI equation, with or without any degree of albuminuria OR
- eGFR 60-89, with UACR of ≥30mg/g
- BMI = 18-39.9
- Blood pressure controlled to ≤140/90
- 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.
- Ability to provide informed consent before any trial related activities are conducted.
Exclusion
- Diagnosed with Type 1 or Type 2 Diabetes Mellitus
- Any prescribed diabetes medication for patients, such as GLP1RA, SGLT2is, and sulphonylureas
- If a patient is on statin, need to be on a stable dose for a month.
- Biopsy proven diagnosis of glomerular disease/glomerulonephritis
- Active smokers,
- Active skin wounds undergoing treatment or recent surgery within 1 month (due to possible aberrations in glycemic control)
- Women who are pregnant, planning to become pregnant, nursing mothers, women of childbearing potential not using birth control measure
- Hypersensitivity to empagliflozin or any of the excipients in Jardiance, reactions such as angioedema
- Patients on dialysis
- eGFR less than 20 mL/min/1.73 m2 by the CKD-EPI equation
- Planned surgery or planned hospital admission within 5 months of participation in the study
- 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)
- Patients with prior history of diagnosis of heart failure with documented EF of less than 50.
- Proven diagnosis of Polycystic Kidney Disease.
Key Trial Info
Start Date :
February 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06110130
Start Date
February 2 2024
End Date
December 1 2028
Last Update
July 20 2025
Active Locations (1)
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1
Washington DC Veterans Affairs Medical Center (688)
Washington D.C., District of Columbia, United States, 20422