Dialysis Clinical Outcomes Revisited (DCOR) Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00324571
Recruitment Status : Completed
First Posted : May 11, 2006
Last Update Posted : March 18, 2015
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Brief 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.

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2001
Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium
U.S. FDA Resources

Primary Outcome Measures :
  1. 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.
  2. Safety will be assessed based on an evaluation of related serious adverse events.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00324571

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

Additional Information:
Responsible Party: Medical Monitor, Genzyme Corporation Identifier: NCT00324571     History of Changes
Other Study ID Numbers: GTC-68-401
First Posted: May 11, 2006    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action