Sympathetic Nervous System Inhibition for the Treatment of Diabetic Kidney Disease

Diabetic Nephropathies Clinical Trial

Official title:

Sympathetic Nervous System Inhibition for the Treatment of Diabetic Nephropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01094769
• Other study ID #: 101/10
• Secondary ID: 58667
• Status: Completed
• Phase: Phase 4
• Start date: April 2011
• Est. completion date: April 2020

Study information

• Verified date: September 2023
• Source: Baker Heart and Diabetes Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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%

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Kidney Diseases

Intervention

Drug:
• Moxonidine
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.
• Placebo
lactose capsule taken once daily

Locations

Country	Name	City	State
Australia	Alfred & Baker Medical Unit	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Baker Heart and Diabetes Institute

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Secondary	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	12 weeks