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NCT02497300 · ClinicalTrials.gov registry record · Phase 2
Vascular Effects of Mineralocorticoid Receptor Antagonism in Kidney Disease
A Phase 2 study of Chronic Kidney Disease and Albuminuria, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT02497300: Completed Phase 2 study of Chronic Kidney Disease and Albuminuria, sponsored by University of Alabama at Birmingham.
NCT02497300 is a Phase 2 study of Chronic Kidney Disease and Albuminuria that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 21 participants, below the 3,207-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02497300, a Phase 2 study of Chronic Kidney Disease and Albuminuria, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
Vascular endothelial dysfunction increases cardiovascular (CV) risk and contributes to the progression of chronic kidney disease (CKD). Mineralocorticoid receptor (MR) antagonists have been shown to improve endothelial function, as well as decrease CV mortality and proteinuria. The specific biochemical pathways that produce these pharmacological effects for MR antagonists, however, are poorly understood. This study investigates the effect of MR antagonism on endothelial function in patients with moderate (stage III) CKD using a randomized, controlled trial. Three specific aims are proposed: Aim 1: To determine if spironolactone improves endothelial function as compared to amiloride in patients with stage III CKD; Aim 2: To determine if oxidative stress is associated with changes in endothelial function by spironolactone compared to amiloride in patients with stage III CKD; and Aim 3: To determine if endothelial dysfunction contributes to albuminuria in patients with stage III CKD. The clinical relevance is to improve understanding of the mechanisms of kidney function decline in CKD in order to develop interventions to delay or prevent dialysis, which would translate into alleviating patient suffering, caregiver burden, and health care costs.
Primary Outcome
The study was not able to meet its recruitment goal, and participant numbers were too low to test the intended primary outcome of "Difference in percent change of ultrasound-guided flow-mediated dilation between 6 weeks of spironolactone vs. 6 weeks of amiloride." The change in 24hr ABPM systolic BP (Baseline - 6 week) is reported here.
Conditions Studied
Interventions
- DRUG Spironolactone
- DRUG Amiloride
Study Locations (1)
Alabama
- Hypertension Research Clinic at UAB - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2015-03 |
| Est. Completion | 2021-07 |
| Phase | Phase 2 |
What the finished NCT02497300 record still lists
NCT02497300 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 3,207-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Chronic Kidney Disease appearing as the primary indexed condition, and to 2 interventions - of which Spironolactone is the first listed.
NCT02497300 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT02497300 about?
NCT02497300 is a clinical study titled "Vascular Effects of Mineralocorticoid Receptor Antagonism in Kidney Disease". Vascular endothelial dysfunction increases cardiovascular (CV) risk and contributes to the progression of chronic kidney disease (CKD). Mineralocorticoid receptor (MR) antagonists have been shown to improve endothelial function, as well as decrease CV mortality and proteinuria. The specific biochemi...
What is the current status of trial NCT02497300?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2015-03. Estimated completion is 2021-07.
What conditions does trial NCT02497300 study?
This clinical trial studies the following conditions: Chronic Kidney Disease, Albuminuria.
What interventions are being tested in trial NCT02497300?
The interventions under investigation include: Spironolactone (DRUG), Amiloride (DRUG).
Who is sponsoring clinical trial NCT02497300?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02497300 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Kidney Disease
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 NCT02497300's enrollment target sits among peer trials
21 88th of 101 higher than 14 of 101 other Chronic Kidney Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Kidney Disease 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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