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Sympathetic Nervous System Inhibition for the Treatment of Diabetic Kidney Disease

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ClinicalTrials.gov Identifier: NCT01094769
Recruitment Status : Unknown
Verified December 2013 by Baker Heart and Diabetes Institute.
Recruitment status was:  Recruiting
First Posted : March 29, 2010
Last Update Posted : December 18, 2013
Sponsor:
Information provided by (Responsible Party):
Baker Heart and Diabetes Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetic Nephropathies Drug: Moxonidine Drug: Placebo Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Sympathetic Nervous System Inhibition for the Treatment of Diabetic Nephropathy
Study Start Date : April 2011
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Moxonidine 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.
Other Name: Physiotens
Placebo Comparator: Placebo Drug: Placebo
lactose capsule taken once daily
Other Name: sugar pill


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 NYHA class II-IV
  • major cardiovascular disease within the previous 6 months
  • left ventricular ejection fraction <55%
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01094769


Contacts
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Contact: Markus P Schlaich, MD 61 3 8532 1502 markus.schlaich@bakeridi.edu.au
Contact: Gavin W Lambert, BSc PhD 61 3 8532 1346 gavin.lambert@bakeridi.edu.au

Locations
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Australia, Victoria
Alfred & Baker Medical Unit Recruiting
Melbourne, Victoria, Australia
Principal Investigator: Markus P Schlaich, MD         
Principal Investigator: Gavin W Lambert, BSc PhD         
Sponsors and Collaborators
Baker Heart and Diabetes Institute
Investigators
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Principal Investigator: Markus P Schlaich, MD Baker Heart and Diabetes Institute
Principal Investigator: Gavin W Lambert, BSc PhD Baker Heart and Diabetes Institute
More Information
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Responsible Party: Baker Heart and Diabetes Institute
ClinicalTrials.gov Identifier: NCT01094769    
Other Study ID Numbers: 2010/10
58667 ( Other Grant/Funding Number: NHMRC )
First Posted: March 29, 2010    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: December 2013
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
 Diabetes Mellitus
Endocrine System Diseases
Moxonidine
Antihypertensive Agents