Role of Finerenone in African American Veterans With Diabetic Kidney Disease

NCT07155694 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 1780095
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Diabetic Kidney Disease

Keywords

Empagliflozin; Finerenone; Empagliflozin and Finerenone combination; Podocyte Injury; Chronic Kidney Disease; Diabetic Kidney Disease; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Urine Exosome Assay

  To study podocyte specific injury markers (podocyte specific proteins, PSP) nephrin, podocalyxin and Wilms'Tumor (WT-1) protein in exosomes urine on empagliflozin or finerenone or combination therapy. Protein western analysis of Exosomes released from Kidney Podocyte is a indicator of kidney Podocyte health. Expressed as a ratio normalized

  16 weeks

Secondary Outcomes (15)

• Renal Function - urine

  16 weeks

• Renal Function - serum

  16 weeks

• CD34 positive Cell Migratory Function

  16 weeks

• CD34 positive Cell Gene Expression

  16 weeks from visit 1

• CD34+ Endothelial Cell Colony Formation Unit (CFU)

  16 weeks

Study Arms (3)

Finerenone

ACTIVE COMPARATOR

Finerenone 10mg orally daily for 4 months

Drug: Finerenone 10 MG

Empagliflozin

ACTIVE COMPARATOR

Empagliflozin 10mg orally daily for 4 months

Drug: Empagliflozin 10 MG

Finerenone and Empagliflozin combination

ACTIVE COMPARATOR

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

Drug: Finerenone 10 MG; Drug: Empagliflozin 10 MG

Interventions

Finerenone 10 MG DRUG

Take Finerenone 10 mg orally daily

Also known as: Kerendia

Finerenone; Finerenone and Empagliflozin combination

Empagliflozin 10 MG DRUG

Take Empagliflozin 10 mg orally daily for 4 months

Also known as: Jardiance

Empagliflozin; Finerenone and Empagliflozin combination

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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.

Sponsors & Collaborators

• Washington D.C. Veterans Affairs Medical Center: lead
• Bayer: collaborator

Study Sites (1)

Washington DC Veterans Affairs Medical Center (688)

Washington D.C., District of Columbia, 20422, United States

Location

MeSH Terms

Conditions

Diabetic Nephropathies; Renal Insufficiency, Chronic; Diabetes Mellitus

Interventions

finerenone; empagliflozin

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Endocrine System Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Sabyasachi Sen, MD, PhD

  Washington DC VA Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabyasachi Sen, MD, PhD

CONTACT

202-745-8000; sabyasachi.sen@va.gov

Shannen Nicole D Ubalde, MS

CONTACT

202-745-8000; shannen.ubalde@va.gov

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Endocrinology

Model Details: The investigators propose a pilot 2-year, prospective interventional matched open-labeled study enrolling 30 African American veteran patients who come to the DC VAMC nephrology and/or: 10 subjects will be exposed to Finerenone 10mg orally daily 10 subjects will be exposed to Empagliflozin 10mg orally daily and 10 subjects will be exposed 10mg Finerenone plus 10mg Empagliflozin combination orally daily

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: September 4, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)