Albuminuria, Diabetes, Macroalbuminuric Diabetic Nephropathy, Microalbuminuria, Proteinuria
Conditions
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.
Interventions
DRUGAliskiren
Aliskiren 150mg daily for 2 weeks and increased to 300 mg daily for 4 weeks.
Sponsors
Cook County Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * Pregnant * History of Angioedema * ACE-I cough * Allergic to ARB, ACE-I, DRI * A1C \> 9%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in albuminuria/proteinuria | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Safety of Triple RAAS inhibition with ACE-I, ARB and DRI | 6 weeks |
Countries
United States
Outcome results
None listed