Triple Blockade of the Renin Angiotensin Aldosterone Syst... | NCT00961207

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

NCT00961207

Sponsor

Cook County Health

Status

Terminated

Last Update Posted

Oct 28, 2013Estimated

Enrollment

2Actual

Phase

Phase 4

Conditions

Microalbuminuria
Macroalbuminuric Diabetic Nephropathy
Diabetes
Proteinuria
Albuminuria

Interventions

Aliskiren
Aliskiren

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Altitude trial which used similar drugs was terminated due to increased ADR.

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Jul 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Aug 17, 2009

First Submission Date that Met QC Criteria

Aug 17, 2009

First Posted Date

Aug 18, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2013

Last Update Posted Date

Oct 28, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aliskiren in Macroalbuminuria	Active Comparator	Aliskiren 150 mg daily for 2 weeks and then increased to 300 mg daily for 4 weeks.	Drug: Aliskiren
Aliskiren Microalbuminuria	Active Comparator	Aliskiren 150 mg daily for 2 weeks and then increased to 300mg daily for 4 weeks	Drug: Aliskiren

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aliskiren	Drug	Aliskiren 150mg daily for 2 weeks and increased to 300 mg daily for 4 weeks.	Aliskiren in Macroalbuminuria

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction in albuminuria/proteinuria		6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Safety of Triple RAAS inhibition with ACE-I, ARB and DRI		6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility 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%

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pete Antonopoulos, PharmD	Cook County Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
John H Stroger Hospital of Cook County		Chicago	Illinois	60612	United States

Type	Date	Date Unknown
Release	Mar 17, 2014
Reset	Apr 18, 2014
Release	Feb 2, 2015
Reset	Feb 4, 2015
Release	Feb 25, 2016
Reset	Mar 25, 2016
Release	Jun 16, 2023
Reset	Jun 21, 2023

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D011507	Proteinuria
D000419	Albuminuria

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C446481	aliskiren

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Mar 17, 2014			Apr 18, 2014
Feb 2, 2015