Recruiting

Empagliflozin

Sponsor:

Washington D.C. Veterans Affairs Medical Center

Code:

NCT06110130

Conditions

Chronic Kidney Diseases

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

Interventions

Empagliflozin 10 MG

Placebo

Study Details

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: We will 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 Objectives:

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. 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 \[11, 27-29\].
3. Correlate urine podocyte-specific protein markers with APOL1 mRNA expression levels in blood mononuclear cells (MNC)

Conditions

Chronic Kidney Diseases

Study ID

NCT06110130

Start date

Feb 2, 2024

Status verified date

Jul, 2026

Completion date

Dec 1, 2028

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. African American veterans
2. Age > 18 years
3. eGFR ≥20-59 mL/min/1.73 m2 by the CKD-EPI equation, with or without any degree of albuminuria OR
4. eGFR 60-89, with UACR of ≥30mg/g
5. BMI = 18-39.9
6. Blood pressure controlled to ≤140/90
7. 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.
8. Ability to provide informed consent before any trial related activities are conducted.

Exclusion Criteria:

1. Diagnosed with Type 1 or Type 2 Diabetes Mellitus
2. Any prescribed diabetes medication for patients, such as GLP1RA, SGLT2is, and sulphonylureas
3. If a patient is on statin, need to be on a stable dose for a month.
4. Biopsy proven diagnosis of glomerular disease/glomerulonephritis
5. Active smokers,
6. Active skin wounds undergoing treatment or recent surgery within 1 month (due to possible aberrations in glycemic control)
7. Women who are pregnant, planning to become pregnant, nursing mothers, women of childbearing potential not using birth control measure
8. Hypersensitivity to empagliflozin or any of the excipients in Jardiance, reactions such as angioedema
9. Patients on dialysis
10. eGFR less than 20 mL/min/1.73 m2 by the CKD-EPI equation
11. Planned surgery or planned hospital admission within 5 months of participation in the study
12. 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)
13. Patients with prior history of diagnosis of heart failure with documented EF of less than 50.
14. Proven diagnosis of Polycystic Kidney Disease.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Placebo

Placebo 10 mg orally daily

active comparator: Empagliflozin

Empagliflozin 10 mg orally daily

Interventions

Empagliflozin 10 MG

Take Empagliflozin 10 mg orally daily for 4 months

Placebo

Take Placebo 10 mg orally daily for 4 months

Primary outcome measure

  • To study kidney dysfunction and podocyte specific injury [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Locations

Washington DC Veterans Affairs Medical Center (688)

Recruiting

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

Contacts

More Information

Sponsor

Washington D.C. Veterans Affairs Medical Center

Last update posted

Aug 21, 2026

Last verified

Jul, 2026

Keywords

  • Non-diabetic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington D.C. Veterans Affairs Medical Center on 2026-08-21.