Dialysis Clinical Outcomes Revisited (DCOR) Trial

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genzyme, a Sanofi Company
• Treatments: Calcium; Calcium, Dietary; Sevelamer

Criteria

Inclusion Criteria:

• patients must be 18 years of age or older,

• on dialysis for more than 3 months,

• require phosphate binder therapy,

• have Medicare as their primary insurance.

Exclusion Criteria:

• dysphagia,

• swallowing disorders,

• severe gastrointestinal motility disorders,

• bowel obstruction.