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

Stopped early · Phase 4

Conditions studied: Microalbuminuria, Macroalbuminuric Diabetic Nephropathy, Diabetes, Proteinuria, Albuminuria

In brief

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.

Key facts

Study ID

NCT00961207

Run by

Cook County Health

People needed

2

Starts

2009-08-01

Expected to finish

2012-09-01

Last updated by the study team

2013-10-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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%

Where it is running

• John H Stroger Hospital of Cook County — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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