Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Dialysis Clinical Outcomes Revisited (DCOR) Trial

This study has been completed.
Information provided by:
Genzyme, a Sanofi Company Identifier:
First received: May 9, 2006
Last updated: July 29, 2009
Last verified: May 2006

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.

Condition Intervention Phase
Chronic Kidney Disease
Drug: Sevelamer hydrochloride
Drug: Calcium-based phosphate binder
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Genzyme, a Sanofi Company:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 2000
Study Start Date: March 2001

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00324571

  Show 73 Study Locations
Sponsors and Collaborators
Genzyme, a Sanofi Company
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Additional Information:
No publications provided

Responsible Party: Medical Monitor, Genzyme Corporation Identifier: NCT00324571     History of Changes
Other Study ID Numbers: GTC-68-401
Study First Received: May 9, 2006
Last Updated: July 29, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Renal Insufficiency, Chronic
Kidney Diseases
Renal Insufficiency
Urologic Diseases processed this record on March 02, 2015