Sympathetic Nervous System Inhibition for the Treatment of Diabetic Kidney Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2020-04-30

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.

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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.

Conditions

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Diabetic Nephropathies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Moxonidine

Group Type EXPERIMENTAL

Moxonidine

Intervention Type DRUG

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.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

lactose capsule taken once daily

Interventions

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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.

Intervention Type DRUG

Placebo

lactose capsule taken once daily

Intervention Type DRUG

Other Intervention Names

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Physiotens sugar pill

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%

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No