RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. 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. 3. Correlate urine podocyte-specific protein markers with APOL1 mRNA expression levels in blood mononuclear cells (MNC)

Official Title

Effect of Empagliflozin on Podocyte Specific Proteins (Injury Markers) in African American Veterans With Albuminuric Non-Diabetic Chronic Kidney Disease

Quick Facts

Study Start:2024-02-02

Study Completion:2026-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06110130

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years to 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. African American veterans 2. Age \> 18 years 3. Stages 2 -3 CKD (eGFR ≥30-89 mL/min/1.73 m2 by the CKD-EPI equation) 4. Albuminuria of 30 mg/g or higher 5. BMI=25-39.9 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.	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. Stage 4-5 CKD defined as an eGFR \< 30 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 known h/o psychiatric illness. 14. Patients with prior history of diagnosis of heart failure with documented EF of less than 50. 15. Proven diagnosis of Polycystic Kidney Disease.

Inclusion Criteria

Exclusion Criteria

1. African American veterans
2. Age \> 18 years
3. Stages 2 -3 CKD (eGFR ≥30-89 mL/min/1.73 m2 by the CKD-EPI equation)
4. Albuminuria of 30 mg/g or higher
5. BMI=25-39.9
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.

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. Stage 4-5 CKD defined as an eGFR \< 30 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 known h/o psychiatric illness.
14. Patients with prior history of diagnosis of heart failure with documented EF of less than 50.
15. Proven diagnosis of Polycystic Kidney Disease.

Contacts and Locations

Study Contact

Sabyasachi Sen, MD

CONTACT

202-745-8000

sabyasachi.sen@va.gov

Shannen Ubalde, BS

CONTACT

202-745-8000

shannen.ubalde@va.gov

Principal Investigator

Sabyasachi Sen, MD

PRINCIPAL_INVESTIGATOR

Washington VA Medical Center

Study Locations (Sites)

Washington DC Veterans Affairs Medical Center (688)

Washington, District of Columbia, 20422

United States

Collaborators and Investigators

Sponsor: Washington D.C. Veterans Affairs Medical Center

Sabyasachi Sen, MD, PRINCIPAL_INVESTIGATOR, Washington VA Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-02

Study Completion Date2026-12-01

Study Record Updates

Study Start Date2024-02-02

Study Completion Date2026-12-01

Terms related to this study

Keywords Provided by Researchers

Non-diabetic

Additional Relevant MeSH Terms

Chronic Kidney Diseases