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CompletedNCT00212901Updated Jul 26, 2007

High Dose Ace Inhibitor Therapy Versus Combination of ACE and ARB Therapy

An interventional study of High dose ACE-I vs ARB in Diabetic Kidney Disease, sponsored by Ottawa Hospital Research Institute. Completed at 1 site in Canada. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2007-07-26.

Sponsored by Ottawa Hospital Research Institute · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Investigation of wheather addition of angiotensin receptor blocker (Irbesartan) to recommended doses of angiotensin converting enzyme inhibitor (trandolapril) is more effective in decreasing amount of protein in urine in patients with diabetic kidney disease than high doses of trandolapril.

02

Conditions studied

  • Diabetic Kidney Disease

Keywords

  • Diabetes
  • Proteinuria
  • Angiotensin converting enzyme inhibitors
  • Angiotensin receptor antagonists
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 30 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Ottawa Hospital Research Institute is the lead sponsor of 538 studies on the registry; 100 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Early diabetic nephropathy as defined by proteinuria between 500mg/24hr and 3g/24hr and GFR>50ml/min (as calculated by the Cockcroft-Gault formula), in the absence of clinical and laboratory evidence of other non-diabetic renal disease.
  2. Controlled blood pressure (\<150/\<90)
  3. Able to give informed consent
  4. Between the ages of 18 and 75
  5. Must be capable of providing a 24 hour urine collection
  6. Negative BHcG test for ruling out pregnancy in women of childbearing age
  7. Currently taking an angiotensin converting enzyme inhibitor

Exclusion criteria

-

Exclusion Criteria:

  1. Creatinine clearance \<50ml/min or 24hour protein excretion >3gm/d.
  2. Hypotension as defined by the inability to add an ARB or increase ACE-I dose secondary to hypotensive symptomatology or a systolic Bp \<100mmHg.
  3. Serum potassium >5.5 on two separate occasions in the previous six months
  4. Previous adverse reaction to angiotensin receptor antagonist medication
  5. Use of NSAIDS including COX2 inhibitors
  6. Pregnant or nursing women will be excluded
  7. Currently taking an angiotensin receptor antagonist

    -

05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Interventions

  • DrugHigh dose ACE-I vs ARB
06

What researchers measure

Primary outcomes

  1. reducing proteinuria

Secondary outcomes

  1. glomerular filtration rate

  2. side-effects of hypotension, postural symptom

07

Study locations

1 site
  • The Ottawa Hospital
    Ottawa, Ontario K1H 7W9, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00212901
Lead sponsor
Ottawa Hospital Research Institute
First posted
Sep 21, 2005
Start date
Aug 2004
Completion
Sep 2006
Last update
Jul 26, 2007

Study contacts

Ayub Akbari, MD
principal investigator · OHRI
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2007. You cannot join it, but the record below documents what was studied.

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