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



Status:Terminated
Conditions:Diabetic Neuropathy, Endocrine, Nephrology, Diabetes
Therapuetic Areas:Endocrinology, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:10/14/2017
Start Date:August 2009
End Date:September 2012

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Trial Summary
Trial Overview
Inclusion Criteria

Study of Triple Blockade of the Renin Angiotensin Aldosterone System (RAAS) in Diabetic (Type 1&2) Proteinuric Patients With (ACE-, ARB, DRI)

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.


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%
We found this trial at
1
site
John H Stroger Hospital of Cook County
Chicago, Illinois 60612
?
mi
from
Chicago, IL
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