Diabetic NephropathiesPhase 4NCT01094769
Sympathetic Nervous System Inhibition for the Treatment of Diabetic Kidney Disease
A Phase 4 study testing Moxonidine in people with Diabetic Nephropathies, run by Baker Heart and Diabetes Institute at 1 site in Australia.
Trial summary
The purpose of this study is to determine whether moxonidine is effective in reducing urine albumin levels in patients with diabetic kidney disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Nephropathies
- What is being tested?
- Moxonidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteAustralia
- Study dates
- Apr 2011to Apr 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sympathetic Nervous System Inhibition for the Treatment of Diabetic Nephropathy
The purpose of this study is to determine whether moxonidine is effective in reducing urine albumin levels in patients with diabetic kidney disease.
Read the detailed description
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
- Diabetic Nephropathies
- Being tested
- Moxonidine, Placebo
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoxonidineDrug
Also called Physiotens
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.
PlaceboDrug
Also called sugar pill
lactose capsule taken once daily
| Study group | Role | What they receive |
|---|---|---|
| Moxonidine | Experimental | Not described Receives: Drug: Moxonidine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2010 (estimated)
- Study startApr 2011
- Primary completionJan 2020
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baker Heart and Diabetes Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markus P Schlaich, MD, Principal investigator, Baker Heart and Diabetes InstituteGavin W Lambert, BSc PhD, Principal investigator, Baker Heart and Diabetes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01094769
- Sponsor's protocol ID
- 101/10
- Other IDs
- 58667
- Status last verified
- Sep 2023
- First submitted
- 26 Mar 2010
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sympathetic Nervous System Inhibition for the Treatment of Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT01094769
- Acronym / sponsor ID
- 101/10
- Conditions
- Diabetic Nephropathies
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Baker Heart and Diabetes InstituteUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jan 2020 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 29 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moxonidine | Experimental | Drug: Moxonidine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MoxonidineAlso: PhysiotensPatients 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. | Drug | Moxonidine |
| PlaceboAlso: sugar pilllactose capsule taken once daily | Drug | Placebo |
Primary outcome
Urine albumin/creatinine ratio (UACR)
Time frame: 12 weeks
The primary outcome measure is the difference in the change of UACR between active treatment and placebo from baseline to week 12 of treatment.
1 secondary outcome
muscle sympathetic nerve activity (MSNA)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus P Schlaich, MD principal investigator
Baker Heart and Diabetes Institute
Gavin W Lambert, BSc PhD principal investigator
Baker Heart and Diabetes Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Moxonidine in people with Diabetic Nephropathies, run by Baker Heart and Diabetes Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine albumin/creatinine ratio (UACR) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.