Clinical trial NCT00324571: Dialysis Clinical Outcomes Revisited (DCOR) Trial
Official title: A Randomized, Open Label, Parallel Design Study of Renagel® Phosphate Binder Versus Calcium-Based Phosphate Binders in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Kidney Disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-05-11
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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.
measure: Safety will be assessed based on an evaluation of related serious adverse events.
Secondary outcomes:
Other outcomes:
Locations:
city: Gadsden
country: United States
facility: Gambro Healthcare-Gadsden
state: Alabama
city: Huntsville
country: United States
facility: nTouch Research
state: Alabama
city: Tucson
country: United States
facility: Kidney Health Institute, LLC
state: Arizona
city: El Cerrito
country: United States
facility: Gambro Healthcare
state: California
city: Escondido
country: United States
facility: Palomar Medical Group
state: California
city: Los Angeles
country: United States
facility: Gambro Healthcare-Los Angeles
state: California
city: San Diego
country: United States
facility: Balboa Nephrology Medical Group
state: California
city: Tarzana
country: United States
facility: Nephrology Educational Services and Research
state: California
city: Denver
country: United States
facility: Lowry Dialysis Center
state: Colorado
city: Bridgeport
country: United States
facility: Nephrology Associates, P.C.
state: Connecticut
city: Hartford
country: United States
facility: Gambro Healthcare-Hartford
state: Connecticut
city: New Britain
country: United States
facility: Nephrology Associates
state: Connecticut
city: Coral Gables
country: United States
facility: InterAmerican Dialysis
state: Florida
city: Crystal River
country: United States
facility: DaVita Crystal River Dialysis
state: Florida
city: Miami
country: United States
facility: Gambro Healthcare-Miami
state: Florida
city: Miami
country: United States
facility: Miami Kidney Group
state: Florida
city: Pensacola
country: United States
facility: Pensacola Nephrology, P.A.
state: Florida
city: Plantation
country: United States
facility: Gambro Healthcare-Plantation
state: Florida
city: St. Petersburg
country: United States
facility: America Dialysis
state: Florida
city: Tampa
country: United States
facility: Genesis Clinical Research Corp
state: Florida
city: Americus
country: United States
facility: Gambro Healthcare-Americus
state: Georgia
city: Atlanta
country: United States
facility: nTouch Research
state: Georgia
city: Douglasville
country: United States
facility: Gambro Healthcare-Douglasville
state: Georgia
city: Douglas
country: United States
facility: Gambro Healthcare-Douglas
state: Georgia
city: Dublin
country: United States
facility: Dublin Nephrology
state: Georgia
city: Marietta
country: United States
facility: Georgia Kidney Associates, Inc.
state: Georgia
city: Rome
country: United States
facility: Gambro Healthcare-Rome
state: Georgia
city: Savannah
country: United States
facility: Gambro Healthcare-Savannah
state: Georgia
city: Berwyn
country: United States
facility: MacNeal Renal Lifeline Services
state: Illinois
city: Evergreen Park
country: United States
facility: Southwest Nephrology
state: Illinois
city: Olympia Fields
country: United States
facility: Horizon Healthcare Associates
state: Illinois
city: Peoria
country: United States
facility: Renal Care Associates, S.C.
state: Illinois
city: Springfield
country: United States
facility: Gambro Healthcare-Springfield Central
state: Illinois
city: Springfield
country: United States
facility: Lincolnland Dialysis
state: Illinois
city: Valparaiso
country: United States
facility: Nephrology Specialists, PC.
state: Indiana
city: Wichita
country: United States
facility: Wichita Dialysis Center East
state: Kansas
city: Wichita
country: United States
facility: Wichita Nephrology
state: Kansas
city: Shreveport
country: United States
facility: Northwest Louisiana Nephrology, LLC.
state: Louisiana
city: Bethesda
country: United States
facility: BMA of Washington
state: Maryland
city: Frederick
country: United States
facility: Gambro Healthcare-Frederick
state: Maryland
city: Brockton
country: United States
facility: Associates in Nephrology, P.C.
state: Massachusetts
city: Springfield
country: United States
facility: Western New England Renal and Transplant Associates, Inc.
state: Massachusetts
city: Minneapolis
country: United States
facility: DaVita Clinical Research
state: Minnesota
city: Columbus
country: United States
facility: Nephrology Associates, P.C.
state: Mississippi
city: Kansas City
country: United States
facility: University of Missouri-Kansas City
state: Missouri
city: St. Louis
country: United States
facility: DaVita Crystal City Dialysis
state: Missouri
city: Las Vegas
country: United States
facility: Nephrology and Endocrine Associates
state: Nevada
city: Bronx
country: United States
facility: Bronx Westchester Medical Group
state: New York
city: Asheville
country: United States
facility: Mountain Kidney Associates, P.A.
state: North Carolina
city: Raleigh
country: United States
facility: nTouch Research
state: North Carolina
city: Raleigh
country: United States
facility: Wake Nephrology/Wake Dialysis Clinic
state: North Carolina
city: Wilson
country: United States
facility: Gambro Healthcare-Wilson
state: North Carolina
city: Cincinnati
country: United States
facility: Kidney and Hypertension Center
state: Ohio
city: Columbus
country: United States
facility: Ohio State University College of Pharmacy
state: Ohio
city: Allentown
country: United States
facility: FMC of Bethlehem
state: Pennsylvania
city: Greensburg
country: United States
facility: Fresenius Medical Care
state: Pennsylvania
city: Lancaster
country: United States
facility: Hypertension and Kidney Specialists
state: Pennsylvania
city: Lewistown
country: United States
facility: DaVita Lewistown Dialysis Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: P.C. & Associates
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Nesbitt College of Pharmacy and Nursing Department of Pharmacy Practice
state: Pennsylvania
city: Aiken
country: United States
facility: Gambro Healthcare-Aiken
state: South Carolina
city: Memphis
country: United States
facility: Midsouth Nephrology Consultants
state: Tennessee
city: Dallas
country: United States
facility: Dallas Nephrology Associates
state: Texas
city: Houston
country: United States
facility: Nephrology, Dialysis and Transplant Association
state: Texas
city: Houston
country: United States
facility: West Houston Dialysis
state: Texas
city: San Antonio
country: United States
facility: San Antonio Kidney Disease Center
state: Texas
city: Charlottesville
country: United States
facility: Gambro Healthcare - Charlottesville
state: Virginia
city: Fairfax
country: United States
facility: Clinical Research and Consulting Center, LLC
state: Virginia
city: Norfolk
country: United States
facility: Clinical Research of Tidewater
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University, Division of Nephrology
state: Virginia
city: Vancouver
country: United States
facility: Vancouver Clinic Inc., P.S.
state: Washington
city: San Juan
country: Puerto Rico
facility: Clinical Las Americas
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References: