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TerminatedNCT00961207Updated Oct 28, 2013

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

A Phase 4 interventional study of Aliskiren and Aliskiren in Microalbuminuria, Macroalbuminuric Diabetic Nephropathy and Diabetes, sponsored by Cook County Health. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-10-28.

Sponsored by Cook County Health · Phase 4, Interventional, and Treatment

Why this study was terminated
Altitude trial which used similar drugs was terminated due to increased ADR.
Phase
Phase 4
Study type
Interventional
Enrollment
2
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Microalbuminuria
  • Macroalbuminuric Diabetic Nephropathy
  • Diabetes
  • Proteinuria
  • Albuminuria
03

In context

Diabetic Nephropathies

534 studies on the registry are indexed under Diabetic Nephropathies; 107 are open to participants now.

This study's enrollment of 2 is below the median of 80 across 377 interventional studies indexed under Diabetic Nephropathies.

Browse Diabetic Nephropathies studies →

Lead sponsor

Cook County Health is the lead sponsor of 28 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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%
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Active comparator
    Aliskiren in Macroalbuminuria

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

    Drug: Aliskiren

  • Active comparator
    Aliskiren Microalbuminuria

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

    Drug: Aliskiren

Interventions

  • DrugAliskiren

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

    Also known as: Tekturna

  • DrugAliskiren

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

    Also known as: Tekturna

06

What researchers measure

Primary outcomes

  1. Reduction in albuminuria/proteinuria

    Time frame: 6 weeks

Secondary outcomes

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

    Time frame: 6 weeks

07

Study locations

1 site
  • John H Stroger Hospital of Cook County
    Chicago, Illinois 60612, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00961207
Lead sponsor
Cook County Health
Responsible party
Pete Antonopoulos (Clinical Pharmacist, Cook County Health) — Principal investigator
First posted
Aug 18, 2009
Start date
Aug 2009
Primary completion
Jul 2012
Completion
Sep 2012
Last update
Oct 28, 2013

Study contacts

Pete Antonopoulos, PharmD
principal investigator · Cook County Health

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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