Role of Finerenone in African American Veterans With Diabetic Kidney Disease

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Washington D.C. Veterans Affairs Medical Center
Study ID
NCT07155694
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Diabetic Kidney Disease

Eligibility Criteria

Sex
ALL
Age
20 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

Start date
Sep 30, 2025
Status verified
Aug 2025
Primary completion
Jul 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Finerenone
    Finerenone 10mg orally daily for 4 months
  • Active Comparator: Empagliflozin
    Empagliflozin 10mg orally daily for 4 months
  • Active Comparator: Finerenone and Empagliflozin combination
    Take 10mg Empagliflozin daily, followed by Fineronone 10mg daily after 4 weeks or 1 month of taking empagliflozin. The combination will continue for 3 months or 12 weeks

Primary Outcome Measure

Urine Exosome Assay [ Time Frame: 16 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington DC Veterans Affairs Medical Center (688)Washington D.C.District of Columbia20422
Sabyasachi Sen, MD
[email protected]
202-745-8303
Ping Li, MD
[email protected]
202-745-8000

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