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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00212901

Enrollment

Registered

2005-09-21

Start date

2004-08-31

Completion date

2006-09-30

Last updated

2007-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Kidney Disease

Keywords

Diabetes, Proteinuria, Angiotensin converting enzyme inhibitors, Angiotensin receptor antagonists

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.

Interventions

DRUGHigh dose ACE-I vs ARB

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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 \-

Design outcomes

Primary

Measure	Time frame
reducing proteinuria	—

Secondary

Measure	Time frame
glomerular filtration rate	—
side-effects of hypotension, postural symptom	—

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026