NCT00324571

Dialysis Clinical Outcomes Revisited (DCOR) Trial

A Randomized, Open Label, Parallel Design Study of Renagel® Phosphate Binder Versus Calcium-Based Phosphate Binders in Hemodialysis Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,000 (planned)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	Sevelamer hydrochloride
DRUG	Calcium-based phosphate binder

Timeline

• Start date: 2001-03-01
• Completion: 2006-02-01
• First posted: 2006-05-11
• Last updated: 2015-03-18

Locations

73 sites across 2 countries: United States, Puerto Rico