NCT01094769

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 29, 2010

Completed
1 year until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

Enrollment Period

8.8 years

First QC Date

March 26, 2010

Last Update Submit

September 13, 2023

Conditions

Diabetic Nephropathies

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • muscle sympathetic nerve activity (MSNA)

    12 weeks

Study Arms (2)

Moxonidine

EXPERIMENTAL
Drug: Moxonidine

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

MoxonidineDRUG

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.

Also known as: Physiotens
Moxonidine
PlaceboDRUG

lactose capsule taken once daily

Also known as: sugar pill
Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alfred & Baker Medical Unit

Melbourne, Victoria, Australia

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

moxonidineSugars

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

  • Markus P Schlaich, MD

    Baker Heart and Diabetes Institute

    PRINCIPAL INVESTIGATOR

  • Gavin W Lambert, BSc PhD

    Baker Heart and Diabetes Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2010

First Posted

March 29, 2010

Study Start

April 1, 2011

Primary Completion

January 1, 2020

Study Completion

April 1, 2020

Last Updated

September 14, 2023

Record last verified: 2023-09

Locations

AU(1)