Sympathetic Nervous System Inhibition for the Treatment of Diabetic Kidney Disease

September 13, 2023 updated by: Baker Heart and Diabetes Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

48

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia
        • Alfred & Baker Medical Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
lactose capsule taken once daily
Other Names:
  • sugar pill
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 Names:
  • Physiotens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baker Heart and Diabetes Institute

Investigators

  • Principal Investigator: Gavin W Lambert, BSc PhD, Baker Heart and Diabetes Institute
  • Principal Investigator: Markus P Schlaich, MD, Baker Heart and Diabetes Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

March 26, 2010

First Submitted That Met QC Criteria

March 26, 2010

First Posted (Estimated)

March 29, 2010

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101/10
  • 58667 (Other Grant/Funding Number: NHMRC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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