Vascular Effects of Mineralocorticoid Receptor Antagonism in Kidney Disease

Completed · Phase 2

Conditions studied: Chronic Kidney Disease, Albuminuria

In brief

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.

Key facts

Study ID

NCT02497300

Run by

University of Alabama at Birmingham

People needed

21

Starts

2015-03-01

Expected to finish

2021-07-01

Last updated by the study team

2022-12-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults (18-65 years of age)
• CKD (eGFR 25-60 mL/min/1.73m2) with urine albumin-to-creatinine ratio > 30 mg/g
• CKD (eGFR > 60 mL/min/1.73m2) with urine albumin-to-creatinine ratio ≥ 300 mg/g

You may not qualify if…

• Severe hypertension (HTN) (office BP ≥ 160/100 mm Hg)
• Hypotension (office BP < 110/70 mm Hg)
• Serum potassium > 5 milliequivalent/L
• History of arrhythmia, including atrial fibrillation
• Pregnant or breast feeding woman
• Diabetes mellitus (DM) type 1
• Diabetes mellitus type 2 with glycosylated hemoglobin ≥ 6.5%
• Dementia or cognitive impairment prohibiting consent
• History of ischemic stroke, unstable angina, or myocardial infarction within the past 6 months
• Allergy or intolerance to spironolactone or amiloride
• Use of an MR antagonist or an epithelial sodium channel blocking medication within the last month
• Known primary aldosteronism or renal artery stenosis

Where it is running

• Hypertension Research Clinic at UAB — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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