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

Cook County Health

Status and phase: Terminated; Phase 4

Conditions: Diabetes; Proteinuria; Macroalbuminuric Diabetic Nephropathy; Albuminuria; Microalbuminuria

Treatments: Drug: Aliskiren

Study type: Interventional

Funder types: Other

Identifiers

NCT00961207

JHStrogerH09-083

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Aliskiren in Macroalbuminuria

Active Comparator group

Description:

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

Treatment:

Drug: Aliskiren

Drug: Aliskiren

Aliskiren Microalbuminuria

Active Comparator group

Description:

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

Treatment:

Drug: Aliskiren

Drug: Aliskiren