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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 IDI 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 IDI Heart and Diabetes Institute

March 26, 2010
March 29, 2010
December 18, 2013
April 2011
January 2015   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01094769 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Sympathetic Nervous System Inhibition for the Treatment of Diabetic Kidney Disease
Sympathetic Nervous System Inhibition for the Treatment of Diabetic Nephropathy
The purpose of this study is to determine whether moxonidine is effective in reducing urine albumin levels in patients with diabetic kidney disease.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Diabetic Nephropathies
  • 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
  • Drug: Placebo
    lactose capsule taken once daily
    Other Name: sugar pill
  • Experimental: Moxonidine
    Intervention: Drug: Moxonidine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
48
Same as current
April 2015
January 2015   (Final data collection date for primary outcome measure)

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%
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
 
NCT01094769
2010/10
58667 ( Other Grant/Funding Number: NHMRC )
No
Not Provided
Not Provided
Baker IDI Heart and Diabetes Institute
Baker IDI Heart and Diabetes Institute
Not Provided
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
Baker IDI Heart and Diabetes Institute
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP