MicroalbuminuriaPhase 4NCT00961207
Triple Blockade of the Renin Angiotensin Aldosterone System in Diabetic (Type 1&2) Proteinuric Patients
A Phase 4 study testing Aliskiren in people with Microalbuminuria and Macroalbuminuric Diabetic Nephropathy, run by Cook County Health at 1 site in United States.
Trial summary
Study Hypothesis: Reduction in albuminuria has been shown to decrease progression of diabetic nephropathy. In diabetic nephropathy patients treated with maximal antihypertensive doses with dual RAAS blockade (total daily dose valsartan 320 mg and either enalapril 40 mg or benazepril 40 mg daily, or losartan 100mg)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microalbuminuria, Macroalbuminuric Diabetic Nephropathy, Diabetes
- What is being tested?
- Aliskiren
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Sep 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Macroalbuminuria > 300mg/g
- Microalbuminuria 30-300mg/g
- Stable on max dose of an ACE-I or ARB (Can also be titrated to max dosage of ACE-I and ARB and stable on those doses for at least 2 weeks)
- Blood pressure <130/80 mm Hg at time of enrollment
- Diabetic either Type 1 or 2
Who cannot join
- GFR <60 m/min
- Potassium > 5mg/dl at time of enrollment
- Pregnant
- History of Angioedema
- ACE-I cough
- Allergic to ARB, ACE-I, DRI
- A1C > 9%
Trial locations and contacts
1 site in 1 country.
United States1 site
John H Stroger Hospital of Cook County
Chicago, Illinois, 60612
About this study
Official title: Study of Triple Blockade of the Renin Angiotensin Aldosterone System (RAAS) in Diabetic (Type 1&2) Proteinuric Patients With (ACE-, ARB, DRI)
Study Hypothesis:
Reduction in albuminuria has been shown to decrease progression of diabetic
nephropathy. In diabetic nephropathy patients treated with maximal
antihypertensive doses with dual RAAS blockade (total daily dose valsartan 320
mg and either enalapril 40 mg or benazepril 40 mg daily, or losartan 100mg), persistent
albuminuria reflects further additional RAAS activation. Microvascular renal
disease due to increased RAAS activation may be more effectively treated with
triple blockade by the addition of a direct renin inhibitor (DRI) Aliskiren.
- Conditions
- Microalbuminuria, Macroalbuminuric Diabetic Nephropathy, Diabetes, Proteinuria, Albuminuria
- Being tested
- Aliskiren
- Medical subject headings
- Diabetes Mellitus, Proteinuria, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AliskirenDrug
Also called Tekturna
Aliskiren 150mg daily for 2 weeks and increased to 300 mg daily for 4 weeks.
AliskirenDrug
Also called Tekturna
Aliskiren 150mg daily for 2 weeks and increased to 300 mg daily for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Aliskiren in Macroalbuminuria | Active comparator | Aliskiren 150 mg daily for 2 weeks and then increased to 300 mg daily for 4 weeks. Receives: Drug: Aliskiren |
| Aliskiren Microalbuminuria | Active comparator | Aliskiren 150 mg daily for 2 weeks and then increased to 300mg daily for 4 weeks Receives: Drug: Aliskiren |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in albuminuria/proteinuria
Measured: 6 weeks
Secondary outcomes (1)
Safety of Triple RAAS inhibition with ACE-I, ARB and DRI
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionJul 2012
- Study completionSep 2012
Why it stopped: Altitude trial which used similar drugs was terminated due to increased ADR.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicroalbuminuriaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook County Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Pete Antonopoulos, Cook County Health
- Investigators
- Pete Antonopoulos, PharmD, Principal investigator, Cook County Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00961207
- Sponsor's protocol ID
- JHStrogerH09-083
- Status last verified
- Oct 2013
- First submitted
- 17 Aug 2009
- Last updated
- 28 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Triple Blockade of the Renin Angiotensin Aldosterone System (RAAS) in Diabetic (Type 1&2) Proteinuric Patients With (ACE-, ARB, DRI)
- ClinicalTrials.gov ID
- NCT00961207
- Acronym / sponsor ID
- JHStrogerH09-083
- Conditions
- Microalbuminuria, Macroalbuminuric Diabetic Nephropathy, Diabetes, Proteinuria, Albuminuria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Altitude trial which used similar drugs was terminated due to increased ADR.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Cook County HealthOther government
- Study start
- Aug 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 18 Aug 2009 (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.
Study Hypothesis:
Reduction in albuminuria has been shown to decrease progression of diabetic
nephropathy. In diabetic nephropathy patients treated with maximal
antihypertensive doses with dual RAAS blockade (total daily dose valsartan 320
mg and either enalapril 40 mg or benazepril 40 mg daily, or losartan 100mg), persistent
albuminuria reflects further additional RAAS activation. Microvascular renal
disease due to increased RAAS activation may be more effectively treated with
triple blockade by the addition of a direct renin inhibitor (DRI) Aliskiren.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aliskiren in Macroalbuminuria | Active comparator | Drug: AliskirenAliskiren 150 mg daily for 2 weeks and then increased to 300 mg daily for 4 weeks. |
| Aliskiren Microalbuminuria | Active comparator | Drug: AliskirenAliskiren 150 mg daily for 2 weeks and then increased to 300mg daily for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Macroalbuminuria > 300mg/g
- Microalbuminuria 30-300mg/g
- Stable on max dose of an ACE-I or ARB (Can also be titrated to max dosage of ACE-I and ARB and stable on those doses for at least 2 weeks)
- Blood pressure <130/80 mm Hg at time of enrollment
- Diabetic either Type 1 or 2
Key exclusion criteria (7 listed)
- GFR <60 m/min
- Potassium > 5mg/dl at time of enrollment
- Pregnant
- History of Angioedema
- ACE-I cough
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 |
|---|---|---|
| AliskirenAlso: TekturnaAliskiren 150mg daily for 2 weeks and increased to 300 mg daily for 4 weeks. | Drug | Aliskiren in Macroalbuminuria |
| AliskirenAlso: TekturnaAliskiren 150mg daily for 2 weeks and increased to 300 mg daily for 4 weeks. | Drug | Aliskiren Microalbuminuria |
Primary outcome
Reduction in albuminuria/proteinuria
Time frame: 6 weeks
1 secondary outcome
Safety of Triple RAAS inhibition with ACE-I, ARB and DRI
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: Altitude trial which used similar drugs was terminated due to increased ADR.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2013.
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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.
Pete Antonopoulos, PharmD principal investigator
Cook County Health
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 Aliskiren in people with Microalbuminuria and Macroalbuminuric Diabetic Nephropathy, run by Cook County Health at 1 site in United States.
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 5 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: stopped early, as of the sponsor's last update on 28 Oct 2013. 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 United States. 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. 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 was stopped early (reason given: Altitude trial which used similar drugs was terminated due to increased ADR.). Results are not available in the source record.
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?
Reduction in albuminuria/proteinuria (time frame: 6 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 28 Oct 2013.