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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01094769




Registration number
NCT01094769
Ethics application status
Date submitted
26/03/2010
Date registered
29/03/2010
Date last updated
18/12/2013

Titles & IDs
Public title
Sympathetic Nervous System Inhibition for the Treatment of Diabetic Kidney Disease
Scientific title
Sympathetic Nervous System Inhibition for the Treatment of Diabetic Nephropathy
Secondary ID [1] 0 0
58667
Secondary ID [2] 0 0
2010/10
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Nephropathies 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Moxonidine
Treatment: Drugs - Placebo

Experimental: Moxonidine -

Placebo Comparator: Placebo -


Treatment: Drugs: 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.

Treatment: Drugs: Placebo
lactose capsule taken once daily

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
12 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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%

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred & Baker Medical Unit - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Baker IDI Heart and Diabetes Institute
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01094769
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Markus P Schlaich, MD
Address 0 0
Baker IDI Heart and Diabetes Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Markus P Schlaich, MD
Address 0 0
Country 0 0
Phone 0 0
61 3 8532 1502
Fax 0 0
Email 0 0
markus.schlaich@bakeridi.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01094769