Sympathetic Nervous System Inhibition for the Treatment of Diabetic Kidney Disease

Sympathetic Nervous System Inhibition for the Treatment of Diabetic Nephropathy

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01094769

Enrollment

Registered

2010-03-29

Start date

2011-04-30

Completion date

2020-04-30

Last updated

2023-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Nephropathies

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.

Interventions

DRUGMoxonidine

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.

DRUGPlacebo

lactose capsule taken once daily

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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%

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026