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

Phase 4

Terminated

• Conditions: Microalbuminuria; Macroalbuminuric Diabetic Nephropathy; Diabetes; Proteinuria; Albuminuria
• Interventions: Drug: Aliskiren

• Registration Number: NCT00961207
• Lead Sponsor: Cook County Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-17
• Study First Submitted QC: 2009-08-17
• Study First Posted: 2009-08-18
• Primary Completion: 2012-07
• Study Completion: 2012-09
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-24
• Last Update Posted: 2013-10-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aliskiren in Macroalbuminuria	Aliskiren	Aliskiren 150 mg daily for 2 weeks and then increased to 300 mg daily for 4 weeks.
Aliskiren Microalbuminuria	Aliskiren	Aliskiren 150 mg daily for 2 weeks and then increased to 300mg daily for 4 weeks

Primary Outcome Measures

Name	Time	Method
Reduction in albuminuria/proteinuria	6 weeks

Secondary Outcome Measures

Name	Time	Method
Safety of Triple RAAS inhibition with ACE-I, ARB and DRI	6 weeks

Trial Locations

Locations (1)

John H Stroger Hospital of Cook County; 🇺🇸 Chicago, Illinois, United States