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New treatment option for Chronic Kidney Diseases
Official title Effect of Empagliflozin on Podocyte Specific Proteins in African American Veterans With NDKD
ClinicalTrials.gov ID: NCT06110130
What this study is testing
What is Empagliflozin 10 MG?
Empagliflozin 10 MG is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic kidney diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 90
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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
- people 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.