Triple Blockade of the Renin Angiotensin Aldosterone System in Diabetic (Type 1&2) Proteinuric Patients
NCT ID: NCT00961207
Last Updated: 2013-10-28
Study Results
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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TERMINATED
PHASE4
2 participants
INTERVENTIONAL
2009-08-31
2012-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Aliskiren in Macroalbuminuria
Aliskiren 150 mg daily for 2 weeks and then increased to 300 mg daily for 4 weeks.
Aliskiren
Aliskiren 150mg daily for 2 weeks and increased to 300 mg daily for 4 weeks.
Aliskiren Microalbuminuria
Aliskiren 150 mg daily for 2 weeks and then increased to 300mg daily for 4 weeks
Aliskiren
Aliskiren 150mg daily for 2 weeks and increased to 300 mg daily for 4 weeks.
Interventions
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Aliskiren
Aliskiren 150mg daily for 2 weeks and increased to 300 mg daily for 4 weeks.
Aliskiren
Aliskiren 150mg daily for 2 weeks and increased to 300 mg daily for 4 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Potassium \> 5mg/dl at time of enrollment
* Pregnant
* History of Angioedema
* ACE-I cough
* Allergic to ARB, ACE-I, DRI
* A1C \> 9%
18 Years
ALL
No
Sponsors
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Cook County Health
OTHER_GOV
Responsible Party
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Pete Antonopoulos
Clinical Pharmacist
Principal Investigators
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Pete Antonopoulos, PharmD
Role: PRINCIPAL_INVESTIGATOR
Cook County Health
Locations
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John H Stroger Hospital of Cook County
Chicago, Illinois, United States
Countries
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Other Identifiers
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JHStrogerH09-083
Identifier Type: -
Identifier Source: org_study_id