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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,000
Gambro Healthcare-Gadsden
Gadsden, Alabama, United States
nTouch Research
Huntsville, Alabama, United States
Kidney Health Institute, LLC
Tucson, Arizona, United States
Gambro Healthcare
El Cerrito, California, United States
Palomar Medical Group
Escondido, California, United States
Gambro Healthcare-Los Angeles
Efficacy will be evaluated based on a comparison of the association of Renagel use versus calcium-based phosphate binder use on all-cause mortality, cause-specific mortality (cardiovascular, infection, other), and all-cause hospitalization.
Safety will be assessed based on an evaluation of related serious adverse events.
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Los Angeles, California, United States
Balboa Nephrology Medical Group
San Diego, California, United States
Nephrology Educational Services and Research
Tarzana, California, United States
Lowry Dialysis Center
Denver, Colorado, United States
Nephrology Associates, P.C.
Bridgeport, Connecticut, United States
...and 63 more locations