Role of Finerenone in African American Veterans With Diabetic Kidney Disease

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age20-90
SponsorWashington D.C. Veterans Affairs Medical Center

About this trial

Primary Objectives: To study podocyte specific injury markers (podocyte specific proteins, PSP) nephrin, podocalyxin and Wilms'Tumor (WT-1) protein in exosomes urine from African American Veterans with albuminuric stage 2 and 3 chronic diabetic kidney disease (DKD), using Empagliflozin or Finerenone or combination therapy.

Secondary Objectives: (1). Correlate changes in exosome-based PSP with standardized biomarkers of kidney injury including urine albumin/creatinine ratio (ACR) and estimated GFR. (2) with systemic inflammatory markers (focusing on vascular and endothelial function) that are already established such as interleukins (IL1, IL6, IL-12), hs-CRP and (3) arterial stiffness measures and with (4) APOL1 mRNA expression levels in peripheral blood derived mononuclear cells (MNC).

Eligibility criteria

Qualifiers

Diagnosis of type 2 diabetes (HbA1C at or above 6.5%, or fasting blood glucose of more than 125 or random/ post prandial blood glucose of more than 199mg%)

African American veterans

Age 20-90 years

eGFR ≥25-89 mL/min/1.73 m2 by the CKD-EPI equation)

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Finerenone 10 MG
  • Empagliflozin 10 MG

Treatment groups

30 Participants
are divided into 3 treatment groups

Sponsors and collaborators