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

Sponsor:	John H. Stroger Hospital
Information provided by:	John H. Stroger Hospital
ClinicalTrials.gov Identifier:	NCT00961207

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 IV

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

Drug Information available for: Aldosterone 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 ]

Estimated Enrollment:	30
Study Start Date:	August 2009
Estimated Study Completion Date:	September 2012
Estimated 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	Recruiting
Chicago, Illinois, United States, 60612
Contact: Pete Antonopoulos, PharmD 312-864-5726 1panton@gmail.com
Principal Investigator: Pete Antonopoulos, PharmD
Principal Investigator: Leon Fogelfeld, MD
Principal Investigator: Peter Hart, MD
Sub-Investigator: Gautam Bhanushali, MD
Sub-Investigator: Jadwiga Miernik, MD

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 PharmD, Cook County Health & Hospital Systems
ClinicalTrials.gov Identifier:	NCT00961207 History of Changes
Other Study ID Numbers:	JHStrogerH09-083
Study First Received:	August 17, 2009
Last Updated:	July 7, 2011
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 February 09, 2012