Chronic Kidney Disease Clinical Trial
Official title:
A Randomized, Open Label, Parallel Design Study of Renagel® Phosphate Binder Versus Calcium-Based Phosphate Binders in Hemodialysis Patients
This is a randomized, open-label, parallel-design study to be conducted at 75 centers within
the United States. The study will be described to hemodialysis patients. Informed consent
will be obtained and the inclusion/exclusion criteria reviewed. Eligible patients will be
randomized to receive either Renagel or a calcium-based binder.
Starting from the randomization date, mortality data including survival, death date and
cause of death (vital status information) and morbidity data including hospitalization date
will be recorded for all patients. These data will be collected until the end of the study
(December 31, 2004, ± 2 weeks). Patients completing or terminating from the study will
return to the phosphate binder prescribed by their usual healthcare provider.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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