A Study of Subcutaneous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.
NCT ID: NCT00560404
Last Updated: 2025-09-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
233 participants
INTERVENTIONAL
2008-04-30
2010-12-31
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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1
methoxy polyethylene glycol-epoetin beta [Mircera]
120, 200 or 360 micrograms sc monthly (starting dose)
2
Epoetin alfa
As prescribed
Interventions
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methoxy polyethylene glycol-epoetin beta [Mircera]
120, 200 or 360 micrograms sc monthly (starting dose)
Epoetin alfa
As prescribed
Eligibility Criteria
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Inclusion Criteria
* chronic renal anemia;
* regular hemodialysis with the same schedule of dialysis for \>=12 weeks;
* maintenance therapy with subcutaneous epoetin alfa at the same administration interval for 4 weeks.
Exclusion Criteria
* poorly controlled hypertension requiring interruption of epoetin alfa in previous 6 months;
* acute or chronic bleeding;
* active malignant disease (except non-melanoma skin cancer).
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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Belo Horizonte, , Brazil
Brasília, , Brazil
Campinas, , Brazil
Campo Grande, , Brazil
Cariacica, , Brazil
Curitiba, , Brazil
Curitiba, , Brazil
Fortaleza, , Brazil
Jaboatão dos Guararapes, , Brazil
Joinville, , Brazil
Juiz de Fora, , Brazil
Londrina, , Brazil
Natal, , Brazil
Porto Alegre, , Brazil
Porto Alegre, , Brazil
Ribeirão Preto, , Brazil
Rio de Janeiro, , Brazil
Salvador, , Brazil
São José do Rio Preto, , Brazil
São Luís, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Sorocaba, , Brazil
Countries
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References
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Locatelli F, Choukroun G, Truman M, Wiggenhauser A, Fliser D. Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials. Adv Ther. 2016 Apr;33(4):610-25. doi: 10.1007/s12325-016-0309-6. Epub 2016 Mar 10.
Other Identifiers
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ML21208
Identifier Type: -
Identifier Source: org_study_id
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