Sympathetic Nervous System Inhibition for the Treatment of Diabetic Kidney Disease

Baker Heart and Diabetes Institute

Status and phase

Completed

Phase 4

Conditions

Diabetic Nephropathies

Treatments

Drug: Placebo

Drug: Moxonidine

Study type

Interventional

Funder types

Other

Identifiers

NCT01094769

101/10

58667 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full description

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.

Enrollment

48 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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%