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Design and statistical issues in the homocysteinemia in kidney and end stage renal disease (HOST) study

Division of Nephrology, Stanford University School of Medicine, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, USA

Pamela Hartigan

Cooperative Studies Program Coordinating Center, VA Connecticut Health Care System, West Haven, CT, USA

J Michael Gaziano

Massachusetts Veteran's Epidemiology Research and Information (MAVERIC), Veterans Affairs Medical Center, West Roxbury, MA, USA

Stephen P Fortmann

Prevention Research Center, Stanford University, School of Medicine, Palo Alto, CA, USA

David S Goldfarb

New York Harbor Healthcare System, New York, NY, USA

Jeffrey A Haroldson

Pharmaceutical Management and Research Unit, VA Cooperative Studies Program, Albuquerque, NM, USA

James Kaufman

Renal Section (III), Boston VA Medical Center, MA, USA

Philip Lavori

Stanford University School of Medicine, Cooperative Studies Program, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, USA

Kilmer S McCully

Department of Pathology and Laboratory Medicine, Boston Area Consolidated Laboratories, Boston VA Healthcare System, West Roxbury Campus, West Roxbury, MA, USA

Killian Robinson

Department of Cardiology, Wake Forest University, Baptist Medical Center, Winston Salem, NC, USA

The Homocysteine Study (HOST) Veterans Affairs Cooperative Studies Program No. 453, is a prospective, randomized, two arm, double blind study of patients with end stage renal disease (ESRD) or advanced chronic kidney disease (ACKD, defined as an estimated creatinine clearance of 30 ml/min or less). Its primary objective is to determine whether administration of high doses of three vitamins, folic acid, vitamin B6 and vitamin B12, to lower the high plasma homocysteine levels, will reduce all cause mortality. The secondary objectives are to examine whether the treatment lowers the incidence of myocardial infarction, stroke, amputation of a lower extremity, a composite of death and the foregoing three events, the plasma homocysteine level, and, in ESRD patients undergoing hemodialysis, thrombosis of the vascular access. A unique feature of this trial is that after initial evaluation at enrollment and one return visit the follow up is exclusively by phone (or, if necessary, by mail). The subject is contacted every three months throughout the duration of the study from a central location. The study drug is shipped to the patient from a central location rather supplied locally. In a two year enrollment period, 2006 patients are to be enrolled. The duration of the observation period is four to six years. Data will be stored and analyzed at a coordinating center. The study design has the power to detect a reduction in all cause mortality rate of 17%. Issues related to the unique features of the design of this study are discussed.

Clinical Trials, Vol. 1, No. 5, 451-460 (2004)
DOI: 10.1191/1740774504cn038oa


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