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Clinical Trial
. 2003 Jul;14(7 Suppl 2):S154-65.
doi: 10.1097/01.asn.0000070080.21680.cb.

Design and statistical aspects of the African American Study of Kidney Disease and Hypertension (AASK)

Jennifer J Gassman  1 , Tom Greene, Jackson T Wright Jr, Lawrence Agodoa, George Bakris, Gerald J Beck, Janice Douglas, Ken Jamerson, Julia Lewis, Michael Kutner, Otelio S Randall, Shin-Ru Wang
Affiliations
Clinical Trial

Design and statistical aspects of the African American Study of Kidney Disease and Hypertension (AASK)

Jennifer J Gassman et al. J Am Soc Nephrol. 2003 Jul.

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 m(2). 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.

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Figures

Figure 1.
Figure 1.
Possible scenarios for the comparison of two treatment groups. Shown are six alternative scenarios for the effects of a treatment compared with a reference group on the mean change in GFR from baseline to 4 yr under the two-slope model. The chronic slope is depicted by the slope from 3 mo (1/4 year) to 4 yr, and the total mean slope as the average rate of change from baseline to 4 yr. Panels A and D represent definitive scenarios in which the comparisons between treatment groups of the mean chronic and total slopes are in agreement. The remaining panels depict inconclusive scenarios in which the comparisons of the chronic and total means slopes are not in agreement.
See this image and copyright information in PMC

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