What this study is
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).
What's being tested
- Finerenone 10 MG
Intervention · DRUG
Take Finerenone 10 mg orally daily
- Empagliflozin 10 MG
Intervention · DRUG
Take Empagliflozin 10 mg orally daily for 4 months
Study details
- Sponsor
- Washington D.C. Veterans Affairs Medical Center
- Conditions
- Diabetic Kidney Disease
- Enrolling
- 30 people
- Starts
- 2026-10-01
- Est. completion
- 2027-08
- Design
- Open-label, randomized, parallel groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 20 Years – 90 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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)
- Albuminuria of 30 mg/g or higher
- BMI=18-39.9
- Blood pressure controlled to ≤140/90
- Ability to provide informed consent before any trial related activities are conducted.
You can't join if
- 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 finerenone
- Patients on dialysis
- eGFR less than 25 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openWashington DC Veterans Affairs Medical Center (688)
Washington D.C., District of Columbia, United States
- Sabyasachi Sen, MD · Contact202-745-8303sabyasachi.sen@va.gov
- Ping Li, MD · Contact202-745-8000 ext. 55910ping.li2@va.gov
Study team
Sponsor
Washington D.C. Veterans Affairs Medical Center
Study ID 1780095
Principal investigator
Sabyasachi Sen, MD, PhD
Washington DC VA Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.