Study Stopped
Altitude trial which used similar drugs was terminated due to increased ADR.
Triple Blockade of the Renin Angiotensin Aldosterone System in Diabetic (Type 1&2) Proteinuric Patients
Study of Triple Blockade of the Renin Angiotensin Aldosterone System (RAAS) in Diabetic (Type 1&2) Proteinuric Patients With (ACE-, ARB, DRI)
1 other identifier
interventional
2
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Aug 2009
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 17, 2009
CompletedFirst Posted
Study publicly available on registry
August 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedOctober 28, 2013
October 1, 2013
2.9 years
August 17, 2009
October 24, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction in albuminuria/proteinuria
6 weeks
Secondary Outcomes (1)
Safety of Triple RAAS inhibition with ACE-I, ARB and DRI
6 weeks
Study Arms (2)
Aliskiren in Macroalbuminuria
ACTIVE COMPARATORAliskiren 150 mg daily for 2 weeks and then increased to 300 mg daily for 4 weeks.
Aliskiren Microalbuminuria
ACTIVE COMPARATORAliskiren 150 mg daily for 2 weeks and then increased to 300mg daily for 4 weeks
Interventions
Aliskiren 150mg daily for 2 weeks and increased to 300 mg daily for 4 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
John H Stroger Hospital of Cook County
Chicago, Illinois, 60612, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pete Antonopoulos, PharmD
Cook County Health
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Pharmacist
Study Record Dates
First Submitted
August 17, 2009
First Posted
August 18, 2009
Study Start
August 1, 2009
Primary Completion
July 1, 2012
Study Completion
September 1, 2012
Last Updated
October 28, 2013
Record last verified: 2013-10