Sympathetic Nervous System Inhibition for the Treatment of Diabetic Kidney Disease
The purpose of this study is to determine whether moxonidine is effective in reducing urine albumin levels in patients with diabetic kidney disease.
|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|
- 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.
- 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
|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)|
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||
lactose capsule taken once daily
Other Name: sugar pill
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.
|Contact: Markus P Schlaich, MD||61 3 8532 firstname.lastname@example.org|
|Contact: Gavin W Lambert, BSc PhD||61 3 8532 email@example.com|
|Alfred & Baker Medical Unit||Recruiting|
|Melbourne, Victoria, Australia|
|Principal Investigator: Markus P Schlaich, MD|
|Principal Investigator: Gavin W Lambert, BSc PhD|
|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|