A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.
NCT ID: NCT00077766
Last Updated: 2016-10-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
313 participants
INTERVENTIONAL
2004-03-31
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)
Eligible participants will be administered with RO0503821 (\[methoxy polyethylene glycol-epoetin beta\] {Mircera}) intravenously (IV), every 2 weeks during Weeks 1 through 52. The starting dose of RO0503821 (60, 100, or 180 micro gram \[µg\]) was based on the dose of darbepoetin alfa at the time of randomization (\< 40, 40 to 80, or \> 80 µg per week, respectively).
methoxy polyethylene glycol-epoetin beta [Mircera]
RO0503821 was administered IV, every 2 weeks during Weeks 1 through 52. The starting dose of RO0503821 (60, 100, or 180 micro gram \[µg\]) was based on the dose of darbepoetin alfa at the time of randomization (\< 40, 40 to 80, or \> 80 µg per week, respectively).
Darbepoetin (1x/1-2 Weeks)
Eligible participants will be administered with darbepoetin alfa IV, every week or every 2 weeks during Weeks 1 through 52.
Darbepoetin alfa
Darbepoetin alfa was administered IV, every week or every 2 weeks during Weeks 1 through 52.
Interventions
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Darbepoetin alfa
Darbepoetin alfa was administered IV, every week or every 2 weeks during Weeks 1 through 52.
methoxy polyethylene glycol-epoetin beta [Mircera]
RO0503821 was administered IV, every 2 weeks during Weeks 1 through 52. The starting dose of RO0503821 (60, 100, or 180 micro gram \[µg\]) was based on the dose of darbepoetin alfa at the time of randomization (\< 40, 40 to 80, or \> 80 µg per week, respectively).
Eligibility Criteria
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Inclusion Criteria
* chronic renal anemia;
* on dialysis therapy for at least 12 weeks before screening;
* receiving darbepoetin alfa iv 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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Blacktown, , Australia
Brisbane, , Australia
Clayton, , Australia
Gosford, , Australia
Parkville, , Australia
Sydney, , Australia
Graz, , Austria
Aalst, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Liège, , Belgium
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Kamloops, British Columbia, Canada
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
Halifax, Nova Scotia, Canada
Kitchener, Ontario, Canada
Mississauga, Ontario, Canada
Aalborg, , Denmark
Odense, , Denmark
Roskilde, , Denmark
HUS, , Finland
Aubervilliers, , France
Montpellier, , France
Nice, , France
Strasbourg, , France
Tarbes, , France
Toulouse, , France
Hannoversch Münden, , Germany
Nuremberg, , Germany
Villingen-Schwenningen, , Germany
Bergamo, , Italy
Lecco, , Italy
Livorno, , Italy
Messina, , Italy
Pavia, , Italy
Badalona, , Spain
Barcelona, , Spain
Córdoba, , Spain
Madrid, , Spain
Oviedo, , Spain
Salamanca, , Spain
Santander, , Spain
Karlstad, , Sweden
Stockholm, , Sweden
Aarau, , 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.
Canaud B, Mingardi G, Braun J, Aljama P, Kerr PG, Locatelli F, Villa G, Van Vlem B, McMahon AW, Kerloeguen C, Beyer U; STRIATA Study Investigators. Intravenous C.E.R.A. maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study. Nephrol Dial Transplant. 2008 Nov;23(11):3654-61. doi: 10.1093/ndt/gfn320. Epub 2008 Jun 27.
Other Identifiers
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BA17283
Identifier Type: -
Identifier Source: org_study_id