High Dose Ace Inhibitor Therapy Versus Combination of ACE and ARB Therapy
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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