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

Diabetic Kidney Disease Clinical Trial

Official title:

Addition of Angiotensin Receptor Blockade to ACE Inhibition Versus High Dose ACE Inhibition for Reduction of Proteinuria in Patients With Diabetic Nephropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00212901
• Other study ID #: 2004482-01
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: July 25, 2007
• Start date: August 2004
• Est. completion date: September 2006

Study information

• Verified date: July 2007
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetic Kidney Disease
• Diabetic Nephropathies
• Kidney Diseases

Intervention

Drug:
• High dose ACE-I vs ARB

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reducing proteinuria
Secondary	glomerular filtration rate
Secondary	side-effects of hypotension, postural symptom