A Study of the Safety and Efficacy of Fabrazyme (Agalsidase Beta) as Compared to Placebo in Patients With Advanced Fabry Disease

Exclusion Criteria

• •Patient has undergone or is currently scheduled for kidney transplantation or is currently on dialysis
• •Patient has acute renal failure
• •Patient has participated in a study employing an investigational drug within 30 days of study entry
• •Patient has diabetes mellitus or presence of confounding renal disease
• •Patient has a history of transient ischemic attack (TIA) or ischemic stroke within 3 months of study entry documented by mild-to-moderate neurological deficit
• •Patient has critical coronary disease
• •Patient has congestive heart failure
• •Patient has severe residual neurological deficit that will confound the detection of new events as determined by an attending neurologist and/or Principal Investigator
• •Patient is unwilling to comply with the requirements of the protocol or the patient has a medical condition, serious intercurrent illness, or extenuating circumstances that would significantly decrease study compliance, including prescribed follow-up