drugset / Trial / NCT07155694

Role of Finerenone in African American Veterans With Diabetic Kidney Disease

NCT07155694

Phase 4 Not yet recruiting 30 enrolled Washington D.C. Veterans Affairs Medical Center Bayer · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

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).

Timeline

Start
2025-09
Primary completion
2027-07
Completion
2027-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Empagliflozin Small molecule 10 mg Oral
Comparator Finerenone Small molecule 10 mg Oral