Effect of Empagliflozin on Podocyte Specific Proteins in African American Veterans With NDKD

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19-90
SponsorWashington D.C. Veterans Affairs Medical Center

About this trial

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)

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Empagliflozin 10 MG
  • Placebo

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators