Sympathetic Nervous System Inhibition for the Treatment of Diabetic Kidney Disease

Baker Heart and Diabetes Institute48 enrolled

Overview

The purpose of this study is to determine whether moxonidine is effective in reducing urine albumin levels in patients with diabetic kidney disease.

This study will investigate the effect of moxonidine in lowering urine albumin excretion and limiting further damage to the kidneys in patients with diabetic nephropathy. Reducing urine albumin excretion in type 2 diabetic patients is an indicator of successful treatment. Previous studies have shown that drugs that work in a similar fashion to moxonidine (intervene with the sympathetic nervous system)have been very effective in reducing the amount of albumin in the urine and are associated with long term renal and cardiovascular protection.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetic Nephropathies

Interventions

MoxonidineDRUG

Patients will receive moxonidine treatment for 12 weeks, at a dose of 0.4mg/d for the first 6 weeks of treatment followed by up-titration of the dose to 0.6 mg/d for the final 6 weeks.

PlaceboDRUG

lactose capsule taken once daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age: 18-75 years * diabetic nephropathy as defined by the mean of three consecutive early morning urinary albumin-creatinine ratios (UACR) of \>300mg per gram, or \> 200mg per gram in patients receiving therapy targeted at blockade of the RAS Exclusion Criteria: * non-diabetic kidney disease * UACR of more than 3500mg per gram, an estimated glomerular filtration rate of less than 30ml/min/1.73m2. * chronic urinary tract infection. * severe hypertension * heart failure New York Heart Association (NYHA) class II-IV * major cardiovascular disease within the previous 6 months * left ventricular ejection fraction \<55%

Locations (1)

Alfred & Baker Medical Unit

Melbourne, Victoria, Australia

Outcomes

Primary Outcomes

Urine albumin/creatinine ratio (UACR)

The primary outcome measure is the difference in the change of UACR between active treatment and placebo from baseline to week 12 of treatment.

Time frame: 12 weeks

Secondary Outcomes

muscle sympathetic nerve activity (MSNA)

Secondary outcome measure is the difference between active and placebo treatment in the change from baseline to week 12 of treatment in muscle sympathetic nerve activity

Time frame: 12 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.