Sympathetic Nervous System Inhibition for the Treatment of Diabetic Kidney Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Baker IDI Heart and Diabetes Institute
Sponsor:
Information provided by (Responsible Party):
Baker IDI Heart and Diabetes Institute
ClinicalTrials.gov Identifier:
NCT01094769
First received: March 26, 2010
Last updated: December 16, 2013
Last verified: December 2013
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Baker IDI Heart and Diabetes Institute
ClinicalTrials.gov Identifier: NCT01094769     History of Changes
Other Study ID Numbers: 2010/10, 58667
Study First Received: March 26, 2010
Last Updated: December 16, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Moxonidine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014