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

This study has been terminated.
(Altitude trial which used similar drugs was terminated and awaiting results to determine future action.)
Sponsor:
Information provided by (Responsible Party):
Pete Antonopoulos, John H. Stroger Hospital
ClinicalTrials.gov Identifier:
NCT00961207
First received: August 17, 2009
Last updated: November 6, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Microalbuminuria
Macroalbuminuria
Diabetes
Proteinuria
Albuminuria
 Drug: Aliskiren
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 4 Study of Triple Blockade (Angiotensin Converting Enzyme Inhibitor (ACE-I), Angiotensin Receptor Blocker(ARB), Direct Renin Inhibitor(DRI)) of the Renin Angiotensin Aldosterone System (RAAS) in Diabetic (Type 1&2) Proteinuric Patients

Resource links provided by NLM:

Drug Information available for: Aliskiren
U.S. FDA Resources

Further study details as provided by John H. Stroger Hospital:

Primary Outcome Measures:
  • Reduction in albuminuria/proteinuria [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety of Triple RAAS inhibition with ACE-I, ARB and DRI [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 2
Study Start Date: August 2009
Study Completion Date: September 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Tekturna

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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%
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00961207

Locations
United States, Illinois
John H Stroger Hospital of Cook County
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
John H. Stroger Hospital
Investigators
Principal Investigator: Pete Antonopoulos, PharmD John H. Stroger Hospital
  More Information

No publications provided

Responsible Party: Pete Antonopoulos, Clinical Pharmacist, John H. Stroger Hospital
ClinicalTrials.gov Identifier: NCT00961207     History of Changes
Other Study ID Numbers: JHStrogerH09-083
Study First Received: August 17, 2009
Last Updated: November 6, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Albuminuria
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
 Angiotensin-Converting Enzyme Inhibitors
Angiotensin Receptor Antagonists
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013