Study of Triple Blockade of the Renin Angiotensin Aldosterone System (RAAS) in Diabetic (Type 1&2) Proteinuric Patients With (ACE-, ARB, DRI)
Overview
- Phase
- Phase 4
- Intervention
- Aliskiren
- Conditions
- Microalbuminuria
- Sponsor
- Cook County Health
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Reduction in albuminuria/proteinuria
- Status
- Terminated
- Last Updated
- 12 years ago
Overview
Brief 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), 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.
Investigators
Pete Antonopoulos
Clinical Pharmacist
Cook County Health
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •GFR \<60 m/min
- •Potassium \> 5mg/dl at time of enrollment
- •History of Angioedema
- •ACE-I cough
- •Allergic to ARB, ACE-I, DRI
- •A1C \> 9%
Arms & Interventions
Aliskiren in Macroalbuminuria
Aliskiren 150 mg daily for 2 weeks and then increased to 300 mg daily for 4 weeks.
Intervention: Aliskiren
Aliskiren Microalbuminuria
Aliskiren 150 mg daily for 2 weeks and then increased to 300mg daily for 4 weeks
Intervention: Aliskiren
Outcomes
Primary Outcomes
Reduction in albuminuria/proteinuria
Time Frame: 6 weeks
Secondary Outcomes
- Safety of Triple RAAS inhibition with ACE-I, ARB and DRI(6 weeks)