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Dialysis Clinical Outcomes Revisited (DCOR) Trial

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Sevelamer hydrochloride
Calcium-based phosphate binder
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gambro Healthcare-Gadsden
  • nTouch Research
  • Kidney Health Institute, LLC
  • Gambro Healthcare
  • Palomar Medical Group
  • Gambro Healthcare-Los Angeles
  • Balboa Nephrology Medical Group
  • Nephrology Educational Services and Research
  • Lowry Dialysis Center
  • Nephrology Associates, P.C.
  • Gambro Healthcare-Hartford
  • Nephrology Associates
  • InterAmerican Dialysis
  • DaVita Crystal River Dialysis
  • Gambro Healthcare-Miami
  • Miami Kidney Group
  • Pensacola Nephrology, P.A.
  • Gambro Healthcare-Plantation
  • America Dialysis
  • Genesis Clinical Research Corp
  • Gambro Healthcare-Americus
  • nTouch Research
  • Gambro Healthcare-Douglasville
  • Gambro Healthcare-Douglas
  • Dublin Nephrology
  • Georgia Kidney Associates, Inc.
  • Gambro Healthcare-Rome
  • Gambro Healthcare-Savannah
  • MacNeal Renal Lifeline Services
  • Southwest Nephrology
  • Horizon Healthcare Associates
  • Renal Care Associates, S.C.
  • Gambro Healthcare-Springfield Central
  • Lincolnland Dialysis
  • Nephrology Specialists, PC.
  • Wichita Dialysis Center East
  • Wichita Nephrology
  • Northwest Louisiana Nephrology, LLC.
  • BMA of Washington
  • Gambro Healthcare-Frederick
  • Associates in Nephrology, P.C.
  • Western New England Renal and Transplant Associates, Inc.
  • DaVita Clinical Research
  • Nephrology Associates, P.C.
  • University of Missouri-Kansas City
  • DaVita Crystal City Dialysis
  • Nephrology and Endocrine Associates
  • Bronx Westchester Medical Group
  • Mountain Kidney Associates, P.A.
  • nTouch Research
  • Wake Nephrology/Wake Dialysis Clinic
  • Gambro Healthcare-Wilson
  • Kidney and Hypertension Center
  • Ohio State University College of Pharmacy
  • FMC of Bethlehem
  • Fresenius Medical Care
  • Hypertension and Kidney Specialists
  • DaVita Lewistown Dialysis Center
  • Albert Einstein Medical Center
  • P.C. & Associates
  • Nesbitt College of Pharmacy and Nursing Department of Pharmacy Practice
  • Gambro Healthcare-Aiken
  • Midsouth Nephrology Consultants
  • Dallas Nephrology Associates
  • Nephrology, Dialysis and Transplant Association
  • West Houston Dialysis
  • San Antonio Kidney Disease Center
  • Gambro Healthcare - Charlottesville
  • Clinical Research and Consulting Center, LLC
  • Clinical Research of Tidewater
  • Virginia Commonwealth University, Division of Nephrology
  • Vancouver Clinic Inc., P.S.
  • Clinical Las Americas

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
May 9, 2006
Last Updated
March 17, 2015
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00324571
Brief Title
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

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Genzyme, a Sanofi Company

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Sevelamer hydrochloride
Intervention Type
Drug
Intervention Name(s)
Calcium-based phosphate binder
Primary Outcome Measure Information:
Title
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.
Title
Safety will be assessed based on an evaluation of related serious adverse events.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Director
Facility Information:
Facility Name
Gambro Healthcare-Gadsden
City
Gadsden
State/Province
Alabama
Country
United States
Facility Name
nTouch Research
City
Huntsville
State/Province
Alabama
Country
United States
Facility Name
Kidney Health Institute, LLC
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Gambro Healthcare
City
El Cerrito
State/Province
California
Country
United States
Facility Name
Palomar Medical Group
City
Escondido
State/Province
California
Country
United States
Facility Name
Gambro Healthcare-Los Angeles
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Balboa Nephrology Medical Group
City
San Diego
State/Province
California
Country
United States
Facility Name
Nephrology Educational Services and Research
City
Tarzana
State/Province
California
Country
United States
Facility Name
Lowry Dialysis Center
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Nephrology Associates, P.C.
City
Bridgeport
State/Province
Connecticut
Country
United States
Facility Name
Gambro Healthcare-Hartford
City
Hartford
State/Province
Connecticut
Country
United States
Facility Name
Nephrology Associates
City
New Britain
State/Province
Connecticut
Country
United States
Facility Name
InterAmerican Dialysis
City
Coral Gables
State/Province
Florida
Country
United States
Facility Name
DaVita Crystal River Dialysis
City
Crystal River
State/Province
Florida
Country
United States
Facility Name
Gambro Healthcare-Miami
City
Miami
State/Province
Florida
Country
United States
Facility Name
Miami Kidney Group
City
Miami
State/Province
Florida
Country
United States
Facility Name
Pensacola Nephrology, P.A.
City
Pensacola
State/Province
Florida
Country
United States
Facility Name
Gambro Healthcare-Plantation
City
Plantation
State/Province
Florida
Country
United States
Facility Name
America Dialysis
City
St. Petersburg
State/Province
Florida
Country
United States
Facility Name
Genesis Clinical Research Corp
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Gambro Healthcare-Americus
City
Americus
State/Province
Georgia
Country
United States
Facility Name
nTouch Research
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Gambro Healthcare-Douglasville
City
Douglasville
State/Province
Georgia
Country
United States
Facility Name
Gambro Healthcare-Douglas
City
Douglas
State/Province
Georgia
Country
United States
Facility Name
Dublin Nephrology
City
Dublin
State/Province
Georgia
Country
United States
Facility Name
Georgia Kidney Associates, Inc.
City
Marietta
State/Province
Georgia
Country
United States
Facility Name
Gambro Healthcare-Rome
City
Rome
State/Province
Georgia
Country
United States
Facility Name
Gambro Healthcare-Savannah
City
Savannah
State/Province
Georgia
Country
United States
Facility Name
MacNeal Renal Lifeline Services
City
Berwyn
State/Province
Illinois
Country
United States
Facility Name
Southwest Nephrology
City
Evergreen Park
State/Province
Illinois
Country
United States
Facility Name
Horizon Healthcare Associates
City
Olympia Fields
State/Province
Illinois
Country
United States
Facility Name
Renal Care Associates, S.C.
City
Peoria
State/Province
Illinois
Country
United States
Facility Name
Gambro Healthcare-Springfield Central
City
Springfield
State/Province
Illinois
Country
United States
Facility Name
Lincolnland Dialysis
City
Springfield
State/Province
Illinois
Country
United States
Facility Name
Nephrology Specialists, PC.
City
Valparaiso
State/Province
Indiana
Country
United States
Facility Name
Wichita Dialysis Center East
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
Wichita Nephrology
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
Northwest Louisiana Nephrology, LLC.
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
BMA of Washington
City
Bethesda
State/Province
Maryland
Country
United States
Facility Name
Gambro Healthcare-Frederick
City
Frederick
State/Province
Maryland
Country
United States
Facility Name
Associates in Nephrology, P.C.
City
Brockton
State/Province
Massachusetts
Country
United States
Facility Name
Western New England Renal and Transplant Associates, Inc.
City
Springfield
State/Province
Massachusetts
Country
United States
Facility Name
DaVita Clinical Research
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Nephrology Associates, P.C.
City
Columbus
State/Province
Mississippi
ZIP/Postal Code
39705
Country
United States
Facility Name
University of Missouri-Kansas City
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
DaVita Crystal City Dialysis
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Nephrology and Endocrine Associates
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Bronx Westchester Medical Group
City
Bronx
State/Province
New York
Country
United States
Facility Name
Mountain Kidney Associates, P.A.
City
Asheville
State/Province
North Carolina
Country
United States
Facility Name
nTouch Research
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Wake Nephrology/Wake Dialysis Clinic
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Gambro Healthcare-Wilson
City
Wilson
State/Province
North Carolina
Country
United States
Facility Name
Kidney and Hypertension Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Ohio State University College of Pharmacy
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
FMC of Bethlehem
City
Allentown
State/Province
Pennsylvania
Country
United States
Facility Name
Fresenius Medical Care
City
Greensburg
State/Province
Pennsylvania
Country
United States
Facility Name
Hypertension and Kidney Specialists
City
Lancaster
State/Province
Pennsylvania
Country
United States
Facility Name
DaVita Lewistown Dialysis Center
City
Lewistown
State/Province
Pennsylvania
Country
United States
Facility Name
Albert Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
P.C. & Associates
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Nesbitt College of Pharmacy and Nursing Department of Pharmacy Practice
City
Wilkes-Barre
State/Province
Pennsylvania
Country
United States
Facility Name
Gambro Healthcare-Aiken
City
Aiken
State/Province
South Carolina
Country
United States
Facility Name
Midsouth Nephrology Consultants
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Dallas Nephrology Associates
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Nephrology, Dialysis and Transplant Association
City
Houston
State/Province
Texas
Country
United States
Facility Name
West Houston Dialysis
City
Houston
State/Province
Texas
Country
United States
Facility Name
San Antonio Kidney Disease Center
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Gambro Healthcare - Charlottesville
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States
Facility Name
Clinical Research and Consulting Center, LLC
City
Fairfax
State/Province
Virginia
Country
United States
Facility Name
Clinical Research of Tidewater
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Virginia Commonwealth University, Division of Nephrology
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Vancouver Clinic Inc., P.S.
City
Vancouver
State/Province
Washington
Country
United States
Facility Name
Clinical Las Americas
City
San Juan
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

Dialysis Clinical Outcomes Revisited (DCOR) Trial

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