A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients
NCT ID: NCT00077610
Last Updated: 2017-01-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
673 participants
INTERVENTIONAL
2004-02-29
2005-08-31
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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RO0503821 (1x/2 Weeks)
Participants received RO0503821 (Mircera \[methoxy polyethylene glycol-epoetin beta\]) once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 microgram \[mcg\]) that was based on the Epoetin dose (\<8000, 8000-16000, \>16000 International units \[IU\]/Week) administered during the week preceding the switch to the study drug.
RO0503821 (1x/2 Weeks)
60, 100, or 180 microgram (mcg) (starting dose) once every two weeks intravenously for 52 weeks.
RO0503821 (1x/4 Weeks)
Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (120, 200, or 360 mcg) that was based on the Epoetin dose (\<8000, 8000-16000, \>16000 IU/Week) administered during the week preceding the switch to the study drug.
RO0503821 (1x/4 Weeks)
120, 200 or 360 mcg (starting dose) once every four weeks intravenously for 52 weeks.
Epoetin (1-3x/Weeks)
Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
Epoetin alfa or beta
intravenously 3 times weekly for 52 weeks, as prescribed
Interventions
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Epoetin alfa or beta
intravenously 3 times weekly for 52 weeks, as prescribed
RO0503821 (1x/2 Weeks)
60, 100, or 180 microgram (mcg) (starting dose) once every two weeks intravenously for 52 weeks.
RO0503821 (1x/4 Weeks)
120, 200 or 360 mcg (starting dose) once every four weeks intravenously for 52 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* chronic renal anemia;
* on dialysis therapy for at least 12 weeks before screening;
* receiving IV 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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Birmingham, Alabama, United States
Mobile, Alabama, United States
Montgomery, Alabama, United States
Encino, California, United States
Irvine, California, United States
Los Angeles, California, United States
Monterey Park, California, United States
Riverside, California, United States
Sacramento, California, United States
San Diego, California, United States
San Diego, California, United States
San Francisco, California, United States
San Jose, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Lakewood, Colorado, United States
Ocala, Florida, United States
Pembroke Pines, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Chicago, Illinois, United States
Maywood, Illinois, United States
Louisville, Kentucky, United States
Covington, Louisiana, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Springfield, Massachusetts, United States
Detroit, Michigan, United States
Brooklyn Center, Minnesota, United States
Paterson, New Jersey, United States
Albuquerque, New Mexico, United States
Brooklyn, New York, United States
Great Neck, New York, United States
Mineola, New York, United States
New York, New York, United States
New York, New York, United States
Stony Brook, New York, United States
The Bronx, New York, United States
Chapel Hill, North Carolina, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Toledo, Ohio, United States
Portland, Oregon, United States
Erie, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Orangeburg, South Carolina, United States
Chattanooga, Tennessee, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Burlington, Vermont, United States
Fairfax, Virginia, United States
Richmond, Virginia, United States
Marshfield, Wisconsin, United States
St. John's, Newfoundland and Labrador, Canada
Kingston, Ontario, Canada
London, Ontario, Canada
Mississauga, Ontario, Canada
Scarborough Village, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Aubervilliers, , France
Bordeaux, , France
La Tronche, , France
Paris, , France
Paris, , France
Paris, , France
Toulouse, , France
Dortmund, , Germany
Ellwangen, , Germany
München, , Germany
Nuremberg, , Germany
Stuttgart, , Germany
Wiesbaden, , Germany
Wiesloch, , Germany
Como, , Italy
Lecco, , Italy
Lodi, , Italy
Milan, , Italy
Pavia, , Italy
Bergen, , Norway
Levanger, , Norway
Lillehammer, , Norway
Trondheim, , Norway
A Coruña, , Spain
Barcelona, , Spain
Madrid, , Spain
Málaga, , Spain
Seville, , Spain
Lausanne, , Switzerland
Lausanne, , Switzerland
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.
Levin NW, Fishbane S, Canedo FV, Zeig S, Nassar GM, Moran JE, Villa G, Beyer U, Oguey D; MAXIMA study investigators. Intravenous methoxy polyethylene glycol-epoetin beta for haemoglobin control in patients with chronic kidney disease who are on dialysis: a randomised non-inferiority trial (MAXIMA). Lancet. 2007 Oct 20;370(9596):1415-21. doi: 10.1016/S0140-6736(07)61599-2.
Other Identifiers
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BA16739
Identifier Type: -
Identifier Source: org_study_id
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