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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00961207
• Other study ID #: JHStrogerH09-083
• Status: Terminated
• Phase: Phase 4
• First received: August 17, 2009
• Last updated: October 24, 2013
• Start date: August 2009
• Est. completion date: September 2012

Study information

• Verified date: October 2013
• Source: John H. Stroger Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: September 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Albuminuria
• Diabetes
• Diabetic Nephropathies
• Macroalbuminuric Diabetic Nephropathy
• Microalbuminuria
• Proteinuria

Intervention

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

Locations

Country	Name	City	State
United States	John H Stroger Hospital of Cook County	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
John H. Stroger Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in albuminuria/proteinuria		6 weeks
Secondary	Safety of Triple RAAS inhibition with ACE-I, ARB and DRI		6 weeks