A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.
NCT ID: NCT00422513
Last Updated: 2011-12-14
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
260 participants
INTERVENTIONAL
2007-03-31
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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methoxy polyethylene glycol-epoetin beta
120-360 micrograms (iv) monthly, starting dose
methoxy polyethylene glycol-epoetin beta
120-360 micrograms intravenous (iv) monthly, starting dose
Epoetin Alfa
As prescribed, (iv), 3 times weekly
Epoetin alfa
As prescribed, iv, 3 times weekly
Interventions
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methoxy polyethylene glycol-epoetin beta
120-360 micrograms intravenous (iv) monthly, starting dose
Epoetin alfa
As prescribed, iv, 3 times weekly
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* CKD (stage V) on outpatient hemodialysis therapy for \>= 3 months;
* CKD-related anemia treated with epoetin alfa iv 3x/week for \>= 3 months;
* average hemoglobin (Hb) 10-12 g/dL over last 3 months.
Exclusion Criteria
* poorly controlled hypertension;
* previous treatment with Mircera.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Birmingham, Alabama, United States
Rainbow City, Alabama, United States
Hot Springs, Arizona, United States
Fairfield, California, United States
Los Alamitos, California, United States
Los Angeles, California, United States
Mountain View, California, United States
Riverside, California, United States
San Diego, California, United States
Simi Valley, California, United States
Whittier, California, United States
Lakewood, Colorado, United States
Brandon, Florida, United States
Hudson, Florida, United States
Lauderdale Lakes, Florida, United States
Miami, Florida, United States
Ocala, Florida, United States
Palm Beach Gardens, Florida, United States
Augusta, Georgia, United States
Gurnee, Illinois, United States
Fort Wayne, Indiana, United States
Detroit, Michigan, United States
Pontiac, Michigan, United States
Sparks, Nevada, United States
New Brunswick, New Jersey, United States
Brooklyn, New York, United States
Brooklyn Center, New York, United States
Flushing, New York, United States
Orchard Park, New York, United States
The Bronx, New York, United States
Williamsville, New York, United States
Raleigh, North Carolina, United States
Toledo, Ohio, United States
Tulsa, Oklahoma, United States
Lancaster, Pennsylvania, United States
Lewistown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
West Homestead, Pennsylvania, United States
Columbia, South Carolina, United States
Orangeburg, South Carolina, United States
Corpus Christi, Texas, United States
Houston, Texas, United States
Chesapeake, Virginia, United States
Fairfax, Virginia, United States
Countries
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Other Identifiers
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ML20336
Identifier Type: -
Identifier Source: org_study_id