Dialysis Clinical Outcomes Revisited (DCOR) Trial - Full Text View

Sponsored by:	Genzyme
Information provided by:	Genzyme
ClinicalTrials.gov Identifier:	NCT00324571

Purpose

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 IV

MedlinePlus related topics: Calcium Dialysis Kidney Failure

Drug Information available for: Calcium gluconate Sevelamer Sevelamer carbonate Sevelamer hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Open Label, Parallel Design Study of Renagel® Phosphate Binder Versus Calcium-Based Phosphate Binders in Hemodialysis Patients

Further study details as provided by Genzyme:

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

Eligibility

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00324571

Show 73 Study Locations

Sponsors and Collaborators

Genzyme

Investigators

Study Director:

Andrew Blair, M.D.

Genzyme

More Information

US FDA Approved Full Prescribing Information for Renagel® This link exits the ClinicalTrials.gov site

Study ID Numbers:	GTC-68-401
Study First Received:	May 9, 2006
Last Updated:	August 22, 2007
ClinicalTrials.gov Identifier:	NCT00324571
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Calcium, Dietary
Sevelamer
Renal Insufficiency
Urologic Diseases

Renal Insufficiency, Chronic
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Chelating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009