Dialysis Clinical Outcomes Revisited (DCOR) Trial
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.
Chronic Kidney Disease
Drug: Sevelamer hydrochloride
Drug: Calcium-based phosphate binder
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized, Open Label, Parallel Design Study of Renagel® Phosphate Binder Versus Calcium-Based Phosphate Binders in Hemodialysis Patients|
- 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.
|Study Start Date:||March 2001|
|Estimated Study Completion Date:||February 2006|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00324571
Show 73 Study Locations
|Study Director:||Medical Monitor||Genzyme, a Sanofi Company|