Triple Blockade of the Renin Angiotensin Aldosterone System in Diabetic (Type 1&2) Proteinuric Patients

Phase 4TerminatedNCT00961207

Cook County Health2 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Microalbuminuria Macroalbuminuric Diabetic Nephropathy Diabetes Proteinuria Albuminuria

Interventions

AliskirenDRUG

Aliskiren 150mg daily for 2 weeks and increased to 300 mg daily for 4 weeks.

AliskirenDRUG

Aliskiren 150mg daily for 2 weeks and increased to 300 mg daily for 4 weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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%

Outcomes

Primary Outcomes

Reduction in albuminuria/proteinuria

Time frame: 6 weeks

Secondary Outcomes

Safety of Triple RAAS inhibition with ACE-I, ARB and DRI