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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2006-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Kidney Disease

Keywords

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Diabetes Proteinuria Angiotensin converting enzyme inhibitors Angiotensin receptor antagonists

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Interventions

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High dose ACE-I vs ARB

Intervention Type DRUG

Eligibility Criteria

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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

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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

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Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Ayub Akbari, MD

Role: PRINCIPAL_INVESTIGATOR

OHRI

Locations

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The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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2004482-01

Identifier Type: -

Identifier Source: org_study_id