Effect of Empagliflozin on Podocyte Specific Proteins in African American Veterans With NDKD
Recruiting · NCT06110130 · Interventional (participants receive a specific treatment) · Lead sponsor: Washington D.C. Veterans Affairs Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
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: We will 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 Objectives: 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 \[11, 27-29\]. 3. Correlate urine podocyte-specific protein markers with APOL1 mRNA expression levels in blood mononuclear cells (MNC)
Who can take part
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed across 1 US state.
- Washington DC Veterans Affairs Medical Center (688) - Washington D.C., District of Columbia, United States