A Study of Subcutaneous Mircera Once Monthly in the Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis
NCT ID: NCT00559273
Last Updated: 2016-11-01
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
307 participants
INTERVENTIONAL
2007-12-31
2009-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Mircera
Participants will receive Mircera (Methoxy polyethylene glycol-epoetin beta), administered subcutaneously (SC) at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
Methoxy polyethylene glycol-epoetin beta
1.2 mcg/kg SC monthly, starting dose
Darbepoetin Alfa
Participants will receive darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
Darbepoetin alfa
0.45 mcg/kg SC weekly or 0.75 mcg/kg every 2 weeks, starting dose
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Methoxy polyethylene glycol-epoetin beta
1.2 mcg/kg SC monthly, starting dose
Darbepoetin alfa
0.45 mcg/kg SC weekly or 0.75 mcg/kg every 2 weeks, starting dose
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Anemia defined as baseline Hb concentration less than (\<) 10.5 gram per deciliter (g/dL)
Exclusion Criteria
* Renal allograft in place
* Immunosuppressive therapy in the 12 weeks prior to screening
* Overt gastrointestinal bleeding and red blood cells (RBC) transfusions within 8 weeks before screening
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Adelaide, , Australia
Clayton, , Australia
Gosford, , Australia
Parkville, , Australia
Reservoir, , Australia
Aalst, , Belgium
Roeselare, , Belgium
Edmonton, Alberta, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Cahors, , France
Clermont-Ferrand, , France
Limoges, , France
Lyon, , France
Nice, , France
Paris, , France
Berlin, , Germany
Bonn, , Germany
Heilbronn, , Germany
Homburg/saar, , Germany
Alexandroupoli, , Greece
Larissa, , Greece
Thessaloniki, , Greece
Volos, , Greece
Hong Kong, , Hong Kong
Baja, , Hungary
Budapest, , Hungary
Esztergom, , Hungary
Hatvan, , Hungary
Szigetvár, , Hungary
Haifa, , Israel
Kfar Saba, , Israel
Petah Tikva, , Israel
Como, , Italy
Lecco, , Italy
Lodi, , Italy
Mestre, , Italy
Modena, , Italy
Pavia, , Italy
Gdansk, , Poland
Katowice, , Poland
Krakow, , Poland
Lodz, , Poland
Radom, , Poland
Rzeszów, , Poland
Sieradz, , Poland
Szczecin, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saratov, , Russia
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Barcelona, , Spain
Barcelona, , Spain
Madrid, , Spain
Madrid, , Spain
Palma de Mallorca, , Spain
Seville, , Spain
Seville, , Spain
Valencia, , Spain
Taichung, , Taiwan
Taipei, , Taiwan
Bangkok, , Thailand
Bangkok, , Thailand
Bangkok, , Thailand
Nakhon Ratchasima, , Thailand
Pathum Thani, , Thailand
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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
Review additional registry numbers or institutional identifiers associated with this trial.
NH20052
Identifier Type: -
Identifier Source: org_study_id