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Completed

NCT Number: NCT01094769

Sympathetic Nervous System Inhibition for the Treatment of Diabetic Kidney Disease

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

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Key information

Conditions

Diabetic Nephropathies Diabetes Complications Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Alfred & Baker Medical Unit

Melbourne, Victoria, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Moxonidine

Drug

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.

Other names: Physiotens

Placebo

Drug

lactose capsule taken once daily

Other names: sugar pill

Primary outcomes

  1. Urine albumin/creatinine ratio (UACR)

    Time frame: 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 outcomes

  1. muscle sympathetic nerve activity (MSNA)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Baker Heart and Diabetes Institute

Other

Registry information

Official study title

Sympathetic Nervous System Inhibition for the Treatment of Diabetic Nephropathy

Important dates

Study start
2011
Primary completion
2020
Study completion
2020
First posted
Mar 29, 2010
Registry last updated
Sep 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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