| Trial ID: | L0048 |
| Source ID: | NCT06110130
|
| Associated Drug: |
Empagliflozin 10 Mg
|
| Title: |
Effect of Empagliflozin on Podocyte Specific Proteins in African American Veterans With NDKD
|
| Acronym: |
NDKD
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Diseases
|
| Interventions: |
DRUG: Empagliflozin 10 MG|DRUG: Placebo
|
| Outcome Measures: |
Primary: To study kidney dysfunction and podocyte specific injury, To study kidney dysfunction and podocyte specific injury in African American Veterans with Non-diabetic kidney disease, following low dose of Empagliflozin therapy. Empagliflozin may be referred to as "Empa" hereafter. Correlate changes in exosome-based podocyte specific proteins with standardized biomarkers of kidney injury including urine albumin/creatinine ratio (ACR) and estimated GFR., 3 years | Secondary: Systemic inflammatory markers, Correlate systemic inflammatory markers (focusing on vascular function and endothelium) that are already established such as interleukins and hs-CRP and arterial stiffness with urine exosome-based podocyte protein estimation To correlate urine podocyte-specific protein markers and serum inflammatory markers with APOL1 mRNA expression levels in blood mononuclear cells (MNC) (c-kit positive cells), 3 years
|
| Sponsor/Collaborators: |
Sponsor: Washington D.C. Veterans Affairs Medical Center | Collaborators: Boehringer Ingelheim
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2024-02-02
|
| Completion Date: |
2026-12-01
|
| Results First Posted: |
|
| Last Update Posted: |
2024-04-29
|
| Locations: |
Washington DC Veterans Affairs Medical Center (688), Washington, District of Columbia, 20422, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT06110130
|
