A Study of Mircera in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis
NCT ID: NCT00081471
Last Updated: 2016-11-02
Study Results
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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COMPLETED
PHASE3
324 participants
INTERVENTIONAL
2004-06-30
2006-07-31
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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1
methoxy polyethylene glycol-epoetin beta [Mircera]
0.6 micrograms/kg sc (starting dose) once every 2 weeks
2
darbepoetin alfa
0.45 micrograms/kg sc (starting dose) weekly
Interventions
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darbepoetin alfa
0.45 micrograms/kg sc (starting dose) weekly
methoxy polyethylene glycol-epoetin beta [Mircera]
0.6 micrograms/kg sc (starting dose) once every 2 weeks
Eligibility Criteria
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Inclusion Criteria
* chronic kidney disease;
* anemia;
* not on dialysis therapy;
* not receiving epoetin.
Exclusion Criteria
* administration of another investigational drug within 4 weeks before screening, or during the study period.
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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Los Angeles, California, United States
Mather, California, United States
Stanford, California, United States
Stamford, Connecticut, United States
Bay Pines, Florida, United States
Ocala, Florida, United States
Shreveport, Louisiana, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Flushing, New York, United States
Cincinnati, Ohio, United States
Portland, Oregon, United States
Allentown, Pennsylvania, United States
Columbia, South Carolina, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Burlington, Vermont, United States
Salem, Virginia, United States
Morgantown, West Virginia, United States
Clayton, , Australia
Liverpool, , Australia
Parkville, , Australia
Perth, , Australia
Antwerp, , Belgium
Leuven, , Belgium
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Kamloops, British Columbia, Canada
New Westminster, British Columbia, Canada
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
St. John's, Newfoundland and Labrador, Canada
Kitchener, Ontario, Canada
London, Ontario, Canada
Scarborough Village, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Angers, , France
Besançon, , France
Chartres, , France
Colmar, , France
Lille, , France
Lyon, , France
Nantes, , France
Paris, , France
Paris, , France
Perpignan, , France
Salouël, , France
Toulouse, , France
Vandœuvre-lès-Nancy, , France
Aschaffenburg, , Germany
Berlin, , Germany
Bonn, , Germany
Dortmund, , Germany
Düsseldorf, , Germany
Tübingen, , Germany
Alexandroupoli, , Greece
Athens, , Greece
Ioannina, , Greece
Piraeus, , Greece
Thessaloniki, , Greece
Cagliari, , Italy
Cuneo, , Italy
Genova, , Italy
Lecco, , Italy
Lodi, , Italy
Modena, , Italy
Napoli, , Italy
Padua, , Italy
Pavia, , Italy
Prato, , Italy
Reggio Calabria, , Italy
Roma, , Italy
Amersfoort, , Netherlands
Heerlen, , Netherlands
San Juan, , Puerto Rico
Almería, , Spain
Barcelona, , Spain
Lleida, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Palma de Mallorca, , Spain
Valencia, , Spain
Borås, , Sweden
Umeå, , Sweden
Birmingham, , United Kingdom
Carshalton, , United Kingdom
Leicester, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Countries
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References
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Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
Other Identifiers
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BA16738
Identifier Type: -
Identifier Source: org_study_id