Triple Blockade of the Renin Angiotensin Aldosterone System in Diabetic (Type 1&2) Proteinuric Patients
Information source: John H. Stroger Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Microalbuminuria; Macroalbuminuria; Diabetes; Proteinuria; Albuminuria
Intervention: Aliskiren (Drug); Aliskiren (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: John H. Stroger Hospital Official(s) and/or principal investigator(s):
Pete Antonopoulos, PharmD, Principal Investigator, Affiliation: John H. Stroger Hospital
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), 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.
Clinical Details
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
Study design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Reduction in albuminuria/proteinuria
Secondary outcome: Safety of Triple RAAS inhibition with ACE-I, ARB and DRI
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Macroalbuminuria > 300mg/g
- Microalbuminuria 30-300mg/g
- Stable on max dose of an ACE-I or ARB
- 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%
Locations and Contacts
John H Stroger Hospital of Cook County, Chicago, Illinois 60612, United States; Recruiting
Pete Antonopoulos, PharmD, Phone: 312-864-5726, Email: 1panton@gmail.com
Pete Antonopoulos, PharmD, Principal Investigator
Leon Fogelfeld, MD, Principal Investigator
Peter Hart, MD, Principal Investigator
Gautam Bhanushali, MD, Sub-Investigator
Jadwiga Miernik, MD, Sub-Investigator
Additional Information
Starting date: August 2009
Last updated: August 17, 2009
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