Effect of Empagliflozin on Podocyte Specific Proteins in African American Veterans With NDKD

NCT06110130 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 1770617
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective:To study podocyte specific injury markers in African American Veterans with non-diabetic kidney disease(NDKD), on empagliflozin therapy. Primary Endpoint: Assess the effect of Empagliflozin on podocyte-specific proteins in exosomes isolated from subjects' urine, such as nephrin, podocalyxin and Wilms'Tumor (WT-1) protein. Secondary Objective:

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

Conditions

Chronic Kidney Diseases

Keywords

Non-diabetic

Outcome Measures

Primary Outcomes (1)

• To study kidney dysfunction and podocyte specific injury

  To study kidney dysfunction and podocyte specific injury in African American Veterans with Non-diabetic kidney disease, following low dose of Empagliflozin therapy. Empagliflozin may be referred to as "Empa" hereafter. Correlate changes in exosome-based podocyte specific proteins with standardized biomarkers of kidney injury including urine albumin/creatinine ratio (ACR) and estimated GFR.

  3 years

Secondary Outcomes (1)

• Systemic inflammatory markers

  3 years

Study Arms (2)

Placebo

ACTIVE COMPARATOR

Placebo 10 mg orally daily

Drug: Placebo

Empagliflozin

ACTIVE COMPARATOR

Empagliflozin 10 mg orally daily

Drug: Empagliflozin 10 MG

Interventions

Empagliflozin 10 MG DRUG

Take Empagliflozin 10 mg orally daily for 4 months

Empagliflozin

Placebo DRUG

Take Placebo 10 mg orally daily for 4 months

Placebo

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• African American veterans
• Age \> 18 years
• eGFR ≥20-59 mL/min/1.73 m2 by the CKD-EPI equation, with or without any degree of albuminuria OR
• eGFR 60-89, with UACR of ≥30mg/g
• BMI = 18-39.9
• Blood pressure controlled to ≤140/90
• Subjects without diabetes: will be screened using routine glucose level test: of less than 126 fasting glucose or less than 200mg/dl of random or post glucose blood glucose level in standard of care laboratory workup.
• Ability to provide informed consent before any trial related activities are conducted.

You may not qualify if:

• Diagnosed with Type 1 or Type 2 Diabetes Mellitus
• Any prescribed diabetes medication for patients, such as GLP1RA, SGLT2is, and sulphonylureas
• 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 any of the excipients in Jardiance, reactions such as angioedema
• Patients on dialysis
• eGFR less than 20 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
• Boehringer Ingelheim: collaborator

Study Sites (1)

Washington DC Veterans Affairs Medical Center (688)

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

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sabyasachi Sen, MD

  Washington VA Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabyasachi Sen, MD

CONTACT

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

Shannen Ubalde, BS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Endocrinology

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: October 31, 2023
• Study Start: February 2, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)