Sympathetic Nervous System Inhibition for the Treatment of Diabetic Kidney Disease

Phase 4

Completed

• Conditions: Diabetic Nephropathies
• Interventions: Drug: Placebo; Drug: Moxonidine

• Registration Number: NCT01094769
• Lead Sponsor: Baker Heart and Diabetes Institute

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2010-03-26
• Study First Submitted QC: 2010-03-26
• Study First Posted: 2010-03-29
• Study Start: 2011-04
• Primary Completion: 2020-01
• Study Completion: 2020-04
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-13
• Last Update Posted: 2023-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Moxonidine	Moxonidine	-

Primary Outcome Measures

Name	Time	Method
Urine albumin/creatinine ratio (UACR)	12 weeks	The primary outcome measure is the difference in the change of UACR between active treatment and placebo from baseline to week 12 of treatment.

Secondary Outcome Measures

Name	Time	Method
muscle sympathetic nerve activity (MSNA)	12 weeks	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

Trial Locations

Locations (1)

Alfred & Baker Medical Unit; 🇦🇺 Melbourne, Victoria, Australia