A Study of Mircera for the Maintenance Treatment of Anemia in Dialysis Patients
NCT ID: NCT00394953
Last Updated: 2017-01-20
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
490 participants
INTERVENTIONAL
2006-12-31
2008-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.
NCT00077766
A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.
NCT00413894
A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease, Not on Dialysis.
NCT00442702
A Study of Subcutaneous Mircera Once Monthly in the Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis
NCT00559273
A Study of Mircera in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis
NCT00081471
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
Eligible participants with anemia in CKD who were on hemodialysis will receive methoxy polyethylene glycol-epoetin beta (MIRCERA \[RO0503821\]) IV once every month up to 52 weeks. The starting dose of MIRCERA which will be administered during the treatment period will depend on the dose of darbepoetin alfa administered during screening period i.e., 120, 200 and 360 mcg for weekly darbepoetin alfa doses of \<40, 40-80, and \>80 mcg, respectively.
methoxy polyethylene glycol-epoetin beta [Mircera]
120, 200 or 360 micrograms iv / month, starting dose
Darbepoetin Alfa
Eligible participants with anemia in CKD who were on hemodialysis will receive darbepoetin alfa (Aranesp) IV once every two weeks up to 26 weeks and darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
Darbepoetin alfa
As prescribed, iv.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Darbepoetin alfa
As prescribed, iv.
methoxy polyethylene glycol-epoetin beta [Mircera]
120, 200 or 360 micrograms iv / month, 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
* chronic renal anemia;
* hemodialysis 3 times weekly for \>=12 weeks before screening, and during screening/baseline period;
* receiving darbepoetin alfa maintenance therapy for \>=8 weeks before screening, and during screening/baseline period.
Exclusion Criteria
* transfusion of red blood cells within 8 weeks before screening or during screening/baseline period;
* active malignancy;
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
Woolloongabba, , Australia
Linz, , Austria
Vienna, , Austria
Vienna, , Austria
Aalst, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Roeselare, , Belgium
Calgary, Alberta, Canada
Hamilton, Ontario, Canada
Kitchener, Ontario, Canada
Mississauga, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Greenfield Park, Quebec, Canada
Trois-Rivières, Quebec, Canada
Aalborg, , Denmark
Hillerød, , Denmark
Roskilde, , Denmark
Tampere, , Finland
Turku, , Finland
Auch, , France
Bordeaux, , France
Boulogne, , France
Castelnau-le-Lez, , France
Cergy-Pontoise, , France
Chamalières, , France
Dijon, , France
Fleury-Mérogis, , France
Hérouville-Saint-Clair, , France
La Tronche, , France
Lyon, , France
Montpellier, , France
Nîmes, , France
Paris, , France
Paris, , France
Reims, , France
Rennes, , France
Saint-Brieuc, , France
Saint-Herblain, , France
Saint-Ouen, , France
Villeurbanne, , France
Bad Hersfeld, , Germany
Bonn, , Germany
Dortmund, , Germany
München, , Germany
Stuttgart, , Germany
Villingen-Schwenningen, , Germany
Bologna, , Italy
Como, , Italy
Genova, , Italy
Lecco, , Italy
Modena, , Italy
Pavia, , Italy
Prato, , Italy
Venezia, , Italy
Amsterdam, , Netherlands
Dordrecht, , Netherlands
Leiria, , Portugal
Alicante, , Spain
Badalona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Bilbao, , Spain
Córdoba, , Spain
León, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Ourense, , Spain
Santander, , Spain
Vigo, , Spain
Vigo, , Spain
Aarau, , Switzerland
Lausanne, , Switzerland
Belfast, , United Kingdom
Canterbury, , United Kingdom
Glasgow, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Truro, , United Kingdom
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.
Carrera F, Lok CE, de Francisco A, Locatelli F, Mann JF, Canaud B, Kerr PG, Macdougall IC, Besarab A, Villa G, Kazes I, Van Vlem B, Jolly S, Beyer U, Dougherty FC; PATRONUS Investigators. Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial. Nephrol Dial Transplant. 2010 Dec;25(12):4009-17. doi: 10.1093/ndt/gfq305. Epub 2010 Jun 3.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BH17847
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.