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

Primary Objective:To study podocyte specific injury markers in African American Veterans with non-diabetic kidney disease(NDKD), on empagliflozin therapy. This study aim to explore mechanistic insights gained from the effect of SGLT2i on podocyte injury markers further in the backdrop of APOL1 expression, to understand the potential therapeutic impact SGLT2i may have in this clinical context.

CT.gov Identifier
NCT06110130
EudraCT Identifier
N/A
CTIS:
N/A
Sponsor
Boehringer Ingelheim
Collaborator
(Other Hospital/Academic/Medical Center)
Study Contact Information
+49 61 32770
Recruiting
Contact Us

Study Details

Diseases
Chronic Kidney Disease
Study Drug
Empagliflozin
Genes
N/A
Study Dates
Feb 2024 - Dec 2027
Sex
Female & Male
Age
19 - 90 Years
Inclusion and Exclusion Criteria
Inclusion Criteria:
  • 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.
Exclusion Criteria:
  • 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.

Protocol Summary

Primary Objective:To study podocyte specific injury markers in African American Veterans with non-diabetic kidney disease(NDKD), on empagliflozin therapy.

This study aim to explore mechanistic insights gained from the effect of SGLT2i on podocyte injury markers further in the backdrop of APOL1 expression, to understand the potential therapeutic impact SGLT2i may have in this clinical context.

Study Locations

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