Dialysis Clinical Outcomes Revisited (DCOR) Trial

NCT ID: NCT00324571

Last Updated: 2015-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-03-31

Study Completion Date

2006-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Sevelamer hydrochloride

Intervention Type DRUG

Calcium-based phosphate binder

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Genzyme Corporation

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Genzyme, a Sanofi Company

Locations

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Gambro Healthcare-Gadsden

Gadsden, Alabama, United States

Site Status

nTouch Research

Huntsville, Alabama, United States

Site Status

Kidney Health Institute, LLC

Tucson, Arizona, United States

Site Status

Gambro Healthcare

El Cerrito, California, United States

Site Status

Palomar Medical Group

Escondido, California, United States

Site Status

Gambro Healthcare-Los Angeles

Los Angeles, California, United States

Site Status

Balboa Nephrology Medical Group

San Diego, California, United States

Site Status

Nephrology Educational Services and Research

Tarzana, California, United States

Site Status

Lowry Dialysis Center

Denver, Colorado, United States

Site Status

Nephrology Associates, P.C.

Bridgeport, Connecticut, United States

Site Status

Gambro Healthcare-Hartford

Hartford, Connecticut, United States

Site Status

Nephrology Associates

New Britain, Connecticut, United States

Site Status

InterAmerican Dialysis

Coral Gables, Florida, United States

Site Status

DaVita Crystal River Dialysis

Crystal River, Florida, United States

Site Status

Gambro Healthcare-Miami

Miami, Florida, United States

Site Status

Miami Kidney Group

Miami, Florida, United States

Site Status

Pensacola Nephrology, P.A.

Pensacola, Florida, United States

Site Status

Gambro Healthcare-Plantation

Plantation, Florida, United States

Site Status

America Dialysis

St. Petersburg, Florida, United States

Site Status

Genesis Clinical Research Corp

Tampa, Florida, United States

Site Status

Gambro Healthcare-Americus

Americus, Georgia, United States

Site Status

nTouch Research

Atlanta, Georgia, United States

Site Status

Gambro Healthcare-Douglas

Douglas, Georgia, United States

Site Status

Gambro Healthcare-Douglasville

Douglasville, Georgia, United States

Site Status

Dublin Nephrology

Dublin, Georgia, United States

Site Status

Georgia Kidney Associates, Inc.

Marietta, Georgia, United States

Site Status

Gambro Healthcare-Rome

Rome, Georgia, United States

Site Status

Gambro Healthcare-Savannah

Savannah, Georgia, United States

Site Status

MacNeal Renal Lifeline Services

Berwyn, Illinois, United States

Site Status

Southwest Nephrology

Evergreen Park, Illinois, United States

Site Status

Horizon Healthcare Associates

Olympia Fields, Illinois, United States

Site Status

Renal Care Associates, S.C.

Peoria, Illinois, United States

Site Status

Gambro Healthcare-Springfield Central

Springfield, Illinois, United States

Site Status

Lincolnland Dialysis

Springfield, Illinois, United States

Site Status

Nephrology Specialists, PC.

Valparaiso, Indiana, United States

Site Status

Wichita Dialysis Center East

Wichita, Kansas, United States

Site Status

Wichita Nephrology

Wichita, Kansas, United States

Site Status

Northwest Louisiana Nephrology, LLC.

Shreveport, Louisiana, United States

Site Status

BMA of Washington

Bethesda, Maryland, United States

Site Status

Gambro Healthcare-Frederick

Frederick, Maryland, United States

Site Status

Associates in Nephrology, P.C.

Brockton, Massachusetts, United States

Site Status

Western New England Renal and Transplant Associates, Inc.

Springfield, Massachusetts, United States

Site Status

DaVita Clinical Research

Minneapolis, Minnesota, United States

Site Status

Nephrology Associates, P.C.

Columbus, Mississippi, United States

Site Status

University of Missouri-Kansas City

Kansas City, Missouri, United States

Site Status

DaVita Crystal City Dialysis

St Louis, Missouri, United States

Site Status

Nephrology and Endocrine Associates

Las Vegas, Nevada, United States

Site Status

Bronx Westchester Medical Group

The Bronx, New York, United States

Site Status

Mountain Kidney Associates, P.A.

Asheville, North Carolina, United States

Site Status

nTouch Research

Raleigh, North Carolina, United States

Site Status

Wake Nephrology/Wake Dialysis Clinic

Raleigh, North Carolina, United States

Site Status

Gambro Healthcare-Wilson

Wilson, North Carolina, United States

Site Status

Kidney and Hypertension Center

Cincinnati, Ohio, United States

Site Status

Ohio State University College of Pharmacy

Columbus, Ohio, United States

Site Status

FMC of Bethlehem

Allentown, Pennsylvania, United States

Site Status

Fresenius Medical Care

Greensburg, Pennsylvania, United States

Site Status

Hypertension and Kidney Specialists

Lancaster, Pennsylvania, United States

Site Status

DaVita Lewistown Dialysis Center

Lewistown, Pennsylvania, United States

Site Status

Albert Einstein Medical Center

Philadelphia, Pennsylvania, United States

Site Status

P.C. & Associates

Philadelphia, Pennsylvania, United States

Site Status

Nesbitt College of Pharmacy and Nursing Department of Pharmacy Practice

Wilkes-Barre, Pennsylvania, United States

Site Status

Gambro Healthcare-Aiken

Aiken, South Carolina, United States

Site Status

Midsouth Nephrology Consultants

Memphis, Tennessee, United States

Site Status

Dallas Nephrology Associates

Dallas, Texas, United States

Site Status

Nephrology, Dialysis and Transplant Association

Houston, Texas, United States

Site Status

West Houston Dialysis

Houston, Texas, United States

Site Status

San Antonio Kidney Disease Center

San Antonio, Texas, United States

Site Status

Gambro Healthcare - Charlottesville

Charlottesville, Virginia, United States

Site Status

Clinical Research and Consulting Center, LLC

Fairfax, Virginia, United States

Site Status

Clinical Research of Tidewater

Norfolk, Virginia, United States

Site Status

Virginia Commonwealth University, Division of Nephrology

Richmond, Virginia, United States

Site Status

Vancouver Clinic Inc., P.S.

Vancouver, Washington, United States

Site Status

Clinical Las Americas

San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

References

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Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

Reference Type DERIVED
PMID: 40576086 (View on PubMed)

Other Identifiers

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GTC-68-401

Identifier Type: -

Identifier Source: org_study_id

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