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NCT06110130 · ClinicalTrials.gov registry record · Phase 4
Effect of Empagliflozin on Podocyte Specific Proteins in African American Veterans With NDKD
A Phase 4 study of Chronic Kidney Diseases, sponsored by Washington D.C. Veterans Affairs Medical Center.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06110130: Recruiting Phase 4 study of Chronic Kidney Diseases, sponsored by Washington D.C. Veterans Affairs Medical Center.
NCT06110130 is a Phase 4 study of Chronic Kidney Diseases that is actively recruiting participants, run by Washington D.C. Veterans Affairs Medical Center. The registered enrollment target is 60 participants, below the 444-participant average among 73 other Chronic Kidney Diseases trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06110130, a Phase 4 study of Chronic Kidney Diseases, is actively recruiting participants, sponsored by Washington D.C. Veterans Affairs Medical Center.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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)
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Empagliflozin 10 MG
Study Locations (1)
District of Columbia
- Washington DC Veterans Affairs Medical Center (688) - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-02-02 |
| Est. Completion | 2028-12-01 |
| Phase | Phase 4 |
What NCT06110130 shows while recruiting
NCT06110130 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 444-participant average among 73 other Chronic Kidney Diseases trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Chronic Kidney Diseases appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06110130 reports a single indexed study location in District of Columbia.
Frequently Asked Questions
What is clinical trial NCT06110130 about?
NCT06110130 is a clinical study titled "Effect of Empagliflozin on Podocyte Specific Proteins in African American Veterans With NDKD". 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, p...
What is the current status of trial NCT06110130?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2024-02-02. Estimated completion is 2028-12-01.
What conditions does trial NCT06110130 study?
This clinical trial studies the following conditions: Chronic Kidney Diseases.
What interventions are being tested in trial NCT06110130?
The interventions under investigation include: Placebo (DRUG), Empagliflozin 10 MG (DRUG).
Who is sponsoring clinical trial NCT06110130?
This trial is sponsored by Washington D.C. Veterans Affairs Medical Center, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06110130 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06110130's enrollment target sits among peer trials
60 51st of 73 higher than 22 of 73 other Chronic Kidney Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Kidney Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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