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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High dose ACE-I vs ARB | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| reducing proteinuria |
| Measure | Description | Time Frame |
|---|---|---|
| glomerular filtration rate | ||
| side-effects of hypotension, postural symptom |
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Inclusion Criteria:
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.
Controlled blood pressure (<150/<90)
Able to give informed consent
Between the ages of 18 and 75
Must be capable of providing a 24 hour urine collection
Negative BHcG test for ruling out pregnancy in women of childbearing age
Currently taking an angiotensin converting enzyme inhibitor
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Exclusion Criteria:
Creatinine clearance <50ml/min or 24hour protein excretion >3gm/d.
Hypotension as defined by the inability to add an ARB or increase ACE-I dose secondary to hypotensive symptomatology or a systolic Bp <100mmHg.
Serum potassium >5.5 on two separate occasions in the previous six months
Previous adverse reaction to angiotensin receptor antagonist medication
Use of NSAIDS including COX2 inhibitors
Pregnant or nursing women will be excluded
Currently taking an angiotensin receptor antagonist
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| Name | Affiliation | Role |
|---|---|---|
| Ayub Akbari, MD | OHRI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital | Ottawa | Ontario | K1H 7W9 | Canada |
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| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| D003920 | Diabetes Mellitus |
| D011507 | Proteinuria |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |