TY - JOUR
T1 - The losartan renal protection study - Rationale, study design and baseline characteristics of RENAAL (Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan)
AU - Brenner, Barry M.
AU - Cooper, Mark E.
AU - De Zeeuw, Dick
AU - Grunfeld, Jean Pierre
AU - Keane, William F.
AU - Kurokawa, Kiyoshi
AU - McGill, Janet B.
AU - Mitch, William E.
AU - Parving, Hans Henrik
AU - Remuzzi, Guiseppe
AU - Ribeiro, Arthur B.
AU - Schluchter, Mark D.
AU - Snavely, Duane
AU - Zhang, Zhongxin
AU - Simpson, Roger
AU - Ramjit, Denise
AU - Shahinfar, Shahnaz
PY - 2000/12
Y1 - 2000/12
N2 - 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. The study has enrolled 1513 patients and is expected to continue for 3.5 years after the last patient has been entered. Eligible patients must have a urinary albumin:creatinine ratio of at least 300 mg/g and serum creatinine between 1.3 to 3.0 mg/dL. Eligible hypertensive or normotensive patients are randomised to receive either losartan or placebo, in addition to their existing antihypertensive therapy. Medications that block angiotensin production or action, are excluded. The primary endpoint is a composite of the time to first event of doubling of serum creatinine, end-stage renal disease, or death; secondary endpoints include cardiovascular events, progression of renal disease, and changes in proteinuria; tertiary endpoints include quality of life, healthcare resource utilisation, and amputations. Patients include Caucasians (48.6%), Blacks (15.2%), Asians (16.7%), and Hispanics (18.2%). Baseline urinary albumin:creatinine ratio and serum creatinine levels average 1867 mg/g and 1.9 mg/dL, respectively. Mean systolic and diastolic blood pressures are 153 and 82 mmHg, respectively. RENAAL will document whether blockade of the AII receptor with losartan produces clinical benefits in patients with Type 2 diabetes and nephropathy.
AB - 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. The study has enrolled 1513 patients and is expected to continue for 3.5 years after the last patient has been entered. Eligible patients must have a urinary albumin:creatinine ratio of at least 300 mg/g and serum creatinine between 1.3 to 3.0 mg/dL. Eligible hypertensive or normotensive patients are randomised to receive either losartan or placebo, in addition to their existing antihypertensive therapy. Medications that block angiotensin production or action, are excluded. The primary endpoint is a composite of the time to first event of doubling of serum creatinine, end-stage renal disease, or death; secondary endpoints include cardiovascular events, progression of renal disease, and changes in proteinuria; tertiary endpoints include quality of life, healthcare resource utilisation, and amputations. Patients include Caucasians (48.6%), Blacks (15.2%), Asians (16.7%), and Hispanics (18.2%). Baseline urinary albumin:creatinine ratio and serum creatinine levels average 1867 mg/g and 1.9 mg/dL, respectively. Mean systolic and diastolic blood pressures are 153 and 82 mmHg, respectively. RENAAL will document whether blockade of the AII receptor with losartan produces clinical benefits in patients with Type 2 diabetes and nephropathy.
KW - Angiotensin II receptor antagonist
KW - Creatinine clearance
KW - End-stage renal disease
KW - Losartan
KW - Non-insulin dependent diabetes mellitus
KW - Proteinuria
UR - http://www.scopus.com/inward/record.url?scp=0034585310&partnerID=8YFLogxK
U2 - 10.3317/jraas.2000.062
DO - 10.3317/jraas.2000.062
M3 - Article
C2 - 11967819
AN - SCOPUS:0034585310
VL - 1
SP - 328
EP - 335
JO - JRAAS - Journal of the Renin-Angiotensin-Aldosterone System
JF - JRAAS - Journal of the Renin-Angiotensin-Aldosterone System
SN - 1470-3203
IS - 4
ER -