CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
Spironolactone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02497300
NCT02497300Phase 2Completed

Vascular Effects of Mineralocorticoid Receptor Antagonism in Kidney Disease

University of Alabama at Birmingham·interventional·Posted Jul 14, 2015·Updated Dec 21, 2022

In Brief

A Phase 2 clinical trial evaluating Spironolactone and Amiloride for Chronic Kidney Disease and Albuminuria. Completed, enrolled 21 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 14, 2015
Enrollment StartMar 1, 2015
Primary CompletionJul 1, 2021
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 11.0 years ago

Interventions

Spironolactonedrug

Amiloridedrug