Back to results

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

Primary Purpose

Microalbuminuria, Macroalbuminuric Diabetic Nephropathy, Diabetes

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Aliskiren

About this trial

This is an interventional treatment trial for Microalbuminuria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%

Sites / Locations

John H Stroger Hospital of Cook County

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Aliskiren in Macroalbuminuria

Aliskiren Microalbuminuria

Arm Description

Aliskiren 150 mg daily for 2 weeks and then increased to 300 mg daily for 4 weeks.

Aliskiren 150 mg daily for 2 weeks and then increased to 300mg daily for 4 weeks

Outcomes

Primary Outcome Measures

Reduction in albuminuria/proteinuria

Secondary Outcome Measures

Safety of Triple RAAS inhibition with ACE-I, ARB and DRI

Full Information

NCT ID

NCT00961207

First Posted

August 17, 2009

Last Updated

October 24, 2013

Sponsor

Cook County Health

1. Study Identification

Unique Protocol Identification Number

NCT00961207

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Terminated

Why Stopped

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

Study Start Date

August 2009 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cook County Health

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Microalbuminuria, Macroalbuminuric Diabetic Nephropathy, Diabetes, Proteinuria, Albuminuria

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aliskiren in Macroalbuminuria

Arm Type

Active Comparator

Arm Description

Aliskiren 150 mg daily for 2 weeks and then increased to 300 mg daily for 4 weeks.

Arm Title

Aliskiren Microalbuminuria

Arm Type

Active Comparator

Arm Description

Aliskiren 150 mg daily for 2 weeks and then increased to 300mg daily for 4 weeks

Intervention Type

Drug

Intervention Name(s)

Aliskiren

Other Intervention Name(s)

Tekturna

Intervention Description

Aliskiren 150mg daily for 2 weeks and increased to 300 mg daily for 4 weeks.

Intervention Type

Drug

Intervention Name(s)

Aliskiren

Other Intervention Name(s)

Tekturna

Intervention Description

Aliskiren 150mg daily for 2 weeks and increased to 300 mg daily for 4 weeks.

Primary Outcome Measure Information:

Title

Reduction in albuminuria/proteinuria

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Safety of Triple RAAS inhibition with ACE-I, ARB and DRI

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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%

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pete Antonopoulos, PharmD

Organizational Affiliation

Cook County Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

John H Stroger Hospital of Cook County

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs