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Sympathetic Nervous System Inhibition for the Treatment of Diabetic Kidney Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2013 by Baker IDI Heart and Diabetes Institute.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01094769
First Posted: March 29, 2010
Last Update Posted: December 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Baker IDI Heart and Diabetes Institute
  Purpose
The purpose of this study is to determine whether moxonidine is effective in reducing urine albumin levels in patients with diabetic kidney disease.

Condition Intervention Phase
Diabetic Nephropathies Drug: Moxonidine Drug: Placebo Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Baker IDI Heart and Diabetes Institute:

Primary Outcome Measures:
  • 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:
  • 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


Estimated Enrollment: 48
Study Start Date: April 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
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
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
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 IDI Heart and Diabetes Institute
Investigators
Principal Investigator: Markus P Schlaich, MD Baker IDI Heart and Diabetes Institute
Principal Investigator: Gavin W Lambert, BSc PhD Baker IDI Heart and Diabetes Institute
  More Information

Responsible Party: Baker IDI Heart and Diabetes Institute
ClinicalTrials.gov Identifier: NCT01094769     History of Changes
Other Study ID Numbers: 2010/10
58667 ( Other Grant/Funding Number: NHMRC )
First Submitted: March 26, 2010
First Posted: March 29, 2010
Last Update Posted: December 18, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Moxonidine
Antihypertensive Agents