The losartan renal protection study — rationale, study design and baseline characteristics of RENAAL (Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan)

摘要: The RENAAL Study is a double-blind, placebo-controlled trial to evaluate the renal protective effects of losartan in Type 2 diabetic patients with nephropathy. study has enrolled 1513 and expected continue for 3.5 years after last patient been entered. Eligible must have urinary albumin:creatinine ratio at least 300 mg/g serum creatinine between 1.3 3.0 mg/dL. hypertensive or normotensive are randomised receive either placebo, addition their existing antihypertensive therapy. Medications that block angiotensin production action, excluded. primary endpoint composite time first event doubling creatinine, end-stage disease, death; secondary endpoints include cardiovascular events, progression changes proteinuria; tertiary quality life, healthcare resource utilisation, amputations. Patients Caucasians (48.6%), Blacks (15.2%), Asians (16.7%), Hispanics (18.2%). Baseline levels average 1867 1.9 mg/dL, respectively. Mean systolic diastolic blood pressures 153 82 mmHg, will document whether blockade AII receptor produces clinical benefits diabetes