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

Not Applicable

Completed

• Conditions: Diabetic Kidney Disease

• Registration Number: NCT00212901
• Lead Sponsor: Ottawa Hospital Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Study Completion: 2006-09
• Status Verified: 2007-07
• Last Update Submitted: 2007-07-25
• Last Update Posted: 2007-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
reducing proteinuria

Secondary Outcome Measures

Name	Time	Method
glomerular filtration rate
side-effects of hypotension, postural symptom

Trial Locations

Locations (1)

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada