Activation of renin-angiotensin plays a crucial role diabetic nephropathy. Angiotensin converting enzyme inhibitor (ACEI) and Angiotensin I receptor blocker (ARB) has been shown renoprotection whether it was used alone or in combination. Aliskiren is a direct renin inhibitor (DRI) that has shown renal benefits and safety when combined with ARB. However, to date, the safety of add on aliskiren to the combination treatment of ACEI and ARB in diabetic nephropathy patients remains to elucidate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
Aliskiren 300mg/d v.s. placebo for 12wk
Lerdsin General Hospital
Bangkok, Thailand
Assess short-term safety of the combination of aliskiren 300 mg/valsartan 160 mg /enalapril 20 mg in patients with diabetic nephropathy
Time frame: 12 wk after randomization
Reduction of systolic blood pressure
Time frame: 12 wk after randomization
Reduction of proteinuria
Time frame: 12 wk after randomization
Change in GFR/mo
Time frame: 12 wk after randomization
Change of Serum prorenin level compare to baseline
Time frame: 12 wk after randomization
Change of Urinary TGFb1 compare to baseline
Time frame: 12 wk after randomization
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