No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
19 – 90
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Washington D.C. Veterans Affairs Medical Center · Federal
Who this trial is looking for
This trial is looking for African American veterans with kidney disease who are interested in taking empagliflozin. Participants will provide urine samples to help researchers understand kidney health.
Are You a Good Fit for This Trial?
Rules you outHeart failure with EF less than 50Polycystic Kidney Disease
You may be able to join if
I am an African American veteran
I am over 18 years old
My kidney function (eGFR) is between 20-89 mL/min/1.73 m2
I do not have diabetes
I have a BMI between 18 and 39.9
My blood pressure is controlled to 140/90 or lower
I can give informed consent
You may not be able to join if
I have been diagnosed with Type 1 or Type 2 Diabetes Mellitus
I take any diabetes medications
I have a biopsy-proven diagnosis of kidney disease
I currently smoke
I have active skin wounds or had surgery in the last month
I am pregnant, planning to become pregnant, or nursing
I am allergic to empagliflozin or any of its ingredients
I have less than 20 mL/min/1.73 m2 kidney function
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 i…
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)
Trial Locations
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Eligibility Criteria
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 …
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.
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