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

Renal Division, Brigham and Women's Hospital, Boston, MA, USA, bmbrenner@ bics.bwh.harvard.edu

Mark E Cooper

Department of Medicine, University of Melbourne, Victoria, Australia

Dick de Zeeuw

Department of Clinical Pharmacology, University of Groningen, The Netherlands

Jean-Pierre Grunfeld

Service Nephrologie, Groupe Hospitalier, Necker-Enfants Maldes, Paris, France

William F Keane

Department of Medicine, Hennepin County Medical Center, Minneapolis, MN, USA

Kiyoshi Kurokawa

Dean's Office, Tokai University School of Medicine, Kanagawa, Japan

Janet B McGill

Department of Medicine, Washington University, St Louis, MO, USA

William E Mitch

Renal Division, Emory University, Atlanta, GA, USA

Hans Henrik Parving

Steno Diabetes Center, Gentofte, Denmark

Guiseppe Remuzzi

Laboratori Negri Bergamo, Instituto Di Ricerche Farmacologiche Mario Negri, Bergamo, Italy

Arthur B Ribeiro

Nephrology Division, Escola Paulista de Medicina, Sao Paulo, Brazil

Mark D Schluchter

Division of Clinical Epidemiology, Department of Pediatrics, Case Western Reserve University, Cleveland, OH, USA

Duane Snavely

Merck Research Laboratories, Blue Bell, PA, USA

Zhongxin Zhang

Merck Research Laboratories, Blue Bell, PA, USA

Roger Simpson

Merck Research Laboratories, Blue Bell, PA, USA

Denise Ramjit

Merck Research Laboratories, Blue Bell, PA, USA

Shahnaz Shahinfar

Merck Research Laboratories, Blue Bell, PA, USA

RENAAL Study Investigators

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.

Key Words: end-stage renal disease • non-insulin dependent diabetes mellitus • losartan • angiotensin II receptor antagonist • creatinine clearance • proteinuria

Journal of Renin-Angiotensin-Aldosterone System, Vol. 1, No. 4, 328-335 (2000)
DOI: 10.3317/jraas.2000.062


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