Back to resultsSympathetic Nervous System Inhibition for the Treatment of Diabetic Kidney Disease
Primary Purpose
Diabetic Nephropathies
Status
Completed
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Moxonidine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Nephropathies
Eligibility 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%
Sites / Locations
- Alfred & Baker Medical Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Moxonidine
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Urine albumin/creatinine ratio (UACR)
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)
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
Full Information
NCT ID
NCT01094769
First Posted
March 26, 2010
Last Updated
September 13, 2023
Sponsor
Baker Heart and Diabetes Institute
1. Study Identification
Unique Protocol Identification Number
NCT01094769
Brief Title
Sympathetic Nervous System Inhibition for the Treatment of Diabetic Kidney Disease
Official Title
Sympathetic Nervous System Inhibition for the Treatment of Diabetic Nephropathy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
April 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baker Heart and Diabetes Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathies
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Moxonidine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Moxonidine
Other Intervention Name(s)
Physiotens
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
sugar pill
Intervention Description
lactose capsule taken once daily
Primary Outcome Measure Information:
Title
Urine albumin/creatinine ratio (UACR)
Description
The primary outcome measure is the difference in the change of UACR between active treatment and placebo from baseline to week 12 of treatment.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
muscle sympathetic nerve activity (MSNA)
Description
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
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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 New York Heart Association (NYHA) class II-IV
major cardiovascular disease within the previous 6 months
left ventricular ejection fraction <55%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus P Schlaich, MD
Organizational Affiliation
Baker Heart and Diabetes Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gavin W Lambert, BSc PhD
Organizational Affiliation
Baker Heart and Diabetes Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alfred & Baker Medical Unit
City
Melbourne
State/Province
Victoria
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Sympathetic Nervous System Inhibition for the Treatment of Diabetic Kidney Disease
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