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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Washington D.C. Veterans Affairs Medical Center
Study ID
NCT06110130
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Kidney Diseases

Eligibility Criteria

Sex
ALL
Age
19 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin 10 MG — DRUG
    Take Empagliflozin 10 mg orally daily for 4 months
  • Placebo — DRUG
    Take Placebo 10 mg orally daily for 4 months

Study Details

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)

Key Dates

Start date
Feb 2, 2024
Status verified
Jul 2025
Primary completion
Dec 1, 2027
Completion
Dec 1, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Placebo
    Placebo 10 mg orally daily
  • Active Comparator: Empagliflozin
    Empagliflozin 10 mg orally daily

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington DC Veterans Affairs Medical Center (688)Washington D.C.District of Columbia20422
Sabyasachi Sen, MD
[email protected]
202-745-8303
Ping Li, MD
[email protected]
202-745-8000

Find similar trials in Washington D.C., DC

By research site
Washington DC Veterans Affairs Medical Center (688)· Washington D.C., DC

Related Studies