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

October 24, 2013 updated by: Pete Antonopoulos, John H. Stroger Hospital

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • John H Stroger Hospital of Cook County

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Aliskiren in Macroalbuminuria
Aliskiren 150 mg daily for 2 weeks and then increased to 300 mg daily for 4 weeks.
Drug: Aliskiren
Aliskiren 150mg daily for 2 weeks and increased to 300 mg daily for 4 weeks.
Other Names:
  • Tekturna
Active Comparator: Aliskiren Microalbuminuria
Aliskiren 150 mg daily for 2 weeks and then increased to 300mg daily for 4 weeks
Drug: Aliskiren
Aliskiren 150mg daily for 2 weeks and increased to 300 mg daily for 4 weeks.
Other Names:
  • Tekturna

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in albuminuria/proteinuria
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety of Triple RAAS inhibition with ACE-I, ARB and DRI
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

John H. Stroger Hospital

Investigators

  • Principal Investigator: Pete Antonopoulos, PharmD, John H. Stroger Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

August 17, 2009

First Submitted That Met QC Criteria

August 17, 2009

First Posted (Estimate)

August 18, 2009

Study Record Updates

Last Update Posted (Estimate)

October 28, 2013

Last Update Submitted That Met QC Criteria

October 24, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JHStrogerH09-083

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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