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

1513 Type 2 diabetic patients with nephropathy (urinary albumin:creatinine ratio ≥300 mg/g and serum creatinine 1.3-3.0 mg/dL). Demographics: Caucasians (48.6%), Blacks (15.2%), Asians (16.7%), and Hispanics (18.2%).

Losartan added to existing antihypertensive therapy (excluding other medications that block angiotensin production or action)

Placebo added to existing antihypertensive therapy

Composite of the time to first event of doubling of serum creatinine, end-stage renal disease, or deathcomposite