Sympathetic Nervous System Inhibition for the Treatment of Diabetic Kidney Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Sympathetic Nervous System Inhibition for the Treatment of Diabetic Nephropathy

Conditions
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Diabetic Nephropathies

Intervention / Treatment
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* Drug: Moxonidine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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%

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moxonidine<br> | Drug: Moxonidine<br>* 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.<br>* Other names: Physiotens;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* lactose capsule taken once daily<br>* Other names: sugar pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 weeks |