A Study of Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients.
NCT ID: NCT00077623
Last Updated: 2016-05-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
572 participants
INTERVENTIONAL
2004-03-31
2005-09-30
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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RO0503821 (1x/2 Weeks)
Eligible participants received RO0503821 (Mircera \[methoxy polyethylene glycol-epoetin beta\]) subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 microgram (mcg) which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 international units (IU)/week, administered during the week preceding the switch to the study drug.
methoxy polyethylene glycol-epoetin beta (Mircera)
60, 100 or 180 micrograms sc (starting dose) every 2 weeks
RO0503821 (1x/4 Weeks)
Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 IU/week administered during the week preceding the switch to the study drug.
methoxy polyethylene glycol-epoetin beta (Mircera)
60, 100 or 180 micrograms sc (starting dose) every 4 weeks
Epoetin Reference
Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks .
epoetin alfa or beta
iv 3 times weekly, as prescribed
Interventions
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epoetin alfa or beta
iv 3 times weekly, as prescribed
methoxy polyethylene glycol-epoetin beta (Mircera)
60, 100 or 180 micrograms sc (starting dose) every 2 weeks
methoxy polyethylene glycol-epoetin beta (Mircera)
60, 100 or 180 micrograms sc (starting dose) every 4 weeks
Eligibility Criteria
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Inclusion Criteria
* chronic renal anemia;
* on dialysis therapy for at least 12 weeks before screening;
* receiving sc epoetin for at least 8 weeks before screening.
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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Hot Springs, Arkansas, United States
Los Angeles, California, United States
Riverside, California, United States
Sacramento, California, United States
San Jose, California, United States
Boston, Massachusetts, United States
Springfield, Massachusetts, United States
Detroit, Michigan, United States
Brooklyn Center, Minnesota, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Toledo, Ohio, United States
Portland, Oregon, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Morgantown, West Virginia, United States
Brussels, , Belgium
Edegem, , Belgium
Ghent, , Belgium
Hasselt, , Belgium
Curitiba, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Brno, , Czechia
Ostrava, , Czechia
Pilsen, , Czechia
Odense, , Denmark
HUS, , Finland
Tampere, , Finland
Turku, , Finland
Bayonne, , France
Boulogne, , France
Cabestany, , France
Caen, , France
Limoges, , France
Nîmes, , France
Pantin, , France
Poitiers, , France
Saint-Germain-en-Laye, , France
Saint-Priest-en-Jarez, , France
Thionville, , France
Tours, , France
Bad Hersfeld, , Germany
Berlin, , Germany
Kaiserslautern, , Germany
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Miskolc, , Hungary
Pécs, , Hungary
Cremona, , Italy
Lecco, , Italy
Mestre, , Italy
Modena, , Italy
Prato, , Italy
Venezia, , Italy
Cuernavaca, , Mexico
Mexico City, , Mexico
Christchurch, , New Zealand
Wellington, , New Zealand
Panama City, , Panama
Gdansk, , Poland
Kielce, , Poland
Krakow, , Poland
Wroclaw, , Poland
Ponce, , Puerto Rico
Durban, , South Africa
Alcorcón, , Spain
Barcelona, , Spain
Madrid, , Spain
Madrid, , Spain
Palma de Mallorca, , Spain
Pamplona, , Spain
Santiago de Compostela, , Spain
Huddinge, , Sweden
Karlstad, , Sweden
Taichung, , Taiwan
Taipei, , Taiwan
Bangkok, , Thailand
Bangkok, , Thailand
Phitsanulok, , Thailand
Belfast, , United Kingdom
Cambridge, , United Kingdom
Dundee, , United Kingdom
Exeter, , 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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BA16740
Identifier Type: -
Identifier Source: org_study_id
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