Effect of Empagliflozin on Podocyte Specific Proteins in African American Veterans With NDKD (NCT06110130) | Clinical Trial Compass
RecruitingPhase 4
Effect of Empagliflozin on Podocyte Specific Proteins in African American Veterans With NDKD
United States60 participantsStarted 2024-02-02
Plain-language summary
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)
Who can participate
Age range19 Years ā 90 Years
SexALL
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Inclusion criteria
ā. African American veterans
ā. Age \> 18 years
ā. eGFR ā„20-59 mL/min/1.73 m2 by the CKD-EPI equation, with or without any degree of albuminuria OR
ā. eGFR 60-89, with UACR of ā„30mg/g
ā. BMI = 18-39.9
ā. Blood pressure controlled to ā¤140/90
ā. 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.
ā. Ability to provide informed consent before any trial related activities are conducted.
Exclusion criteria
ā. Diagnosed with Type 1 or Type 2 Diabetes Mellitus
ā. Any prescribed diabetes medication for patients, such as GLP1RA, SGLT2is, and sulphonylureas
What they're measuring
1
To study kidney dysfunction and podocyte specific injury
Timeframe: 3 years
Trial details
NCT IDNCT06110130
SponsorWashington D.C. Veterans Affairs Medical Center