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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00961207
Recruitment Status : Terminated (Altitude trial which used similar drugs was terminated due to increased ADR.)
First Posted : August 18, 2009
Last Update Posted : October 28, 2013
Sponsor:
Information provided by (Responsible Party):
Pete Antonopoulos, John H. Stroger Hospital

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.


Condition or disease Intervention/treatment Phase
Microalbuminuria Macroalbuminuric Diabetic Nephropathy Diabetes Proteinuria Albuminuria Drug: Aliskiren Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Triple Blockade of the Renin Angiotensin Aldosterone System (RAAS) in Diabetic (Type 1&2) Proteinuric Patients With (ACE-, ARB, DRI)
Study Start Date : August 2009
Actual Primary Completion Date : July 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine


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 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




Primary Outcome Measures :
  1. Reduction in albuminuria/proteinuria [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Safety of Triple RAAS inhibition with ACE-I, ARB and DRI [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00961207


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

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Responsible Party: Pete Antonopoulos, Clinical Pharmacist, John H. Stroger Hospital
ClinicalTrials.gov Identifier: NCT00961207     History of Changes
Other Study ID Numbers: JHStrogerH09-083
First Posted: August 18, 2009    Key Record Dates
Last Update Posted: October 28, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
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Diabetic Nephropathies
Proteinuria
Albuminuria
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Urination Disorders
Urological Manifestations
Signs and Symptoms