NCT06110130RecruitingPhase 4
Effect of Empagliflozin on Podocyte Specific Proteins in African American Veterans With NDKD
Effect of Empagliflozin on Podocyte Specific Proteins (Injury Markers) in African American Veterans With Non-Diabetic Chronic Kidney Disease
Source: ClinicalTrials.gov · Last updated 21 Aug 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 25 Oct 2023
- Start date
- 2 Feb 2024
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- Washington D.C. Veterans Affairs Medical Center
- Diseases
- Chronic kidney disease
- NCT number
- NCT06110130
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 60
- From 2 Feb 2024 to the primary completion date, 1 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active skin wounds undergoing treatment or recent surgery within 1 month (due to possible aberrations in glycemic control)
- Planned surgery or planned hospital admission within 5 months of participation in the study
- Patients with prior history of diagnosis of heart failure with documented EF of less than 50.
Other illness
- Diagnosed with Type 1 or Type 2 Diabetes Mellitus
- Any prescribed diabetes medication for patients, such as GLP1RA, SGLT2is, and sulphonylureas
- Biopsy proven diagnosis of glomerular disease/glomerulonephritis
- Hypersensitivity to empagliflozin or any of the excipients in Jardiance, reactions such as angioedema
- Proven diagnosis of Polycystic Kidney Disease.
Lab values
- eGFR less than 20 mL/min/1.73 m2 by the CKD-EPI equation
Other
- If a patient is on statin, need to be on a stable dose for a month.
- Active smokers,
- Women who are pregnant, planning to become pregnant, nursing mothers, women of childbearing potential not using birth control measure
- Patients on dialysis
- 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)
Who the study is looking for
- 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.
Age in the registry: 19 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Washington DC Veterans Affairs Medical Center (688) Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.