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J Am Soc Nephrol 14:S154-S165, 2003
© 2003 American Society of Nephrology

Supplement Article

Design and Statistical Aspects of the African American Study of Kidney Disease and Hypertension (AASK)

Jennifer J. Gassman*, Tom Greene*, Jackson T. Wright, Jr.{dagger}, Lawrence Agodoa{ddagger}, George Bakris§, Gerald J. Beck*, Janice Douglas{dagger}, Ken Jamerson, Julia Lewis**, Michael Kutner*, Otelio S. Randall{dagger},{ddagger} and Shin-Ru Wang* and The AASK Group*

*Cleveland Clinic Department of Biostatistics; {dagger}Case Western Reserve University School of Medicine and University Hospitals, Cleveland, Ohio; {ddagger}National Institutes of Health, NIDDK, Bethesda, Maryland; §Rush Presbyterian St. Luke’s Medical Center, Chicago, Illinois; University of Michigan, Ann Arbor, Michigan; **Vanderbilt University School of Medicine, Department of Internal Medicine, Nashville, Tennessee; and {dagger}{dagger}Howard University, Washington, D.C.

Correspondence to Dr. Jennifer J. Gassman, Department of Biostatistics, WB-4, Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland OH 44195-2195. Phone: 216-444-9938; Fax: 216-445-2781;

ABSTRACT. The African American Study of Kidney Disease and Hypertension (AASK) is a multicenter randomized clinical trial designed to test the effectiveness of three anti-hypertensive drug regimens and two levels of BP control on the progression of hypertensive kidney disease. Participants include African-American men and women aged 18 to 70 yr who have hypertensive kidney disease and GFR between 20 and 65 ml/min per 1.73 m2. The three anti-hypertensive drug regimens include an angiotensin converting enzyme inhibitor (ramipril), a dihydropyridine calcium channel blocker (amlodipine) or a beta-blocker (metoprolol) as initial therapy. The BP control levels are a lower goal (mean arterial pressure, <=92 mmHg) and a usual goal (mean arterial pressure, 102 to 107 mmHg inclusive). The primary outcome is rate of change in renal function as measured by GFR, assessed by 125 I-iothalamate clearance. The main secondary patient outcome is a composite including the following events: (1) reduction in GFR by 50%, (2) end-stage renal disease, or (3) death. E-mail: jgassman@bio.ri.ccf.org




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