A Study of Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia
NCT ID: NCT00550680
Last Updated: 2016-03-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
208 participants
INTERVENTIONAL
2008-01-31
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Mircera in Renal Anemia
Participants with chronic renal anemia who have been previously treated with erythropoiesis-stimulating agent (ESA) therapy will receive IV Mircera every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg will be determined by the dose of ESA received prior to administration of study treatment. Subsequent doses will be adjusted to maintain Hb concentrations within target of 10.5 and 12.5 grams per deciliter (g/dL).
Methoxy polyethylene glycol-epoetin beta
Participants will receive a starting dose of 120, 200, or 360 mcg via IV injection. Thereafter, the once-monthly dose will be titrated to achieve target Hb concentrations.
Interventions
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Methoxy polyethylene glycol-epoetin beta
Participants will receive a starting dose of 120, 200, or 360 mcg via IV injection. Thereafter, the once-monthly dose will be titrated to achieve target Hb concentrations.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Chronic renal anemia
* Stable epoetin alfa or darbepoetin alfa therapy for past 2 months
* Hemodialysis therapy for ≥3 months
Exclusion Criteria
* Poorly controlled hypertension requiring hospitalization or interruption of ESA treatment in previous 6 months
* Acute or chronic bleeding
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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Aigáleo, , Greece
Athens, , Greece
Athens, , Greece
Athens, , Greece
Athens, , Greece
Athens, , Greece
Athens, , Greece
Athens, , Greece
Corinthos, , Greece
Daphni-athens, , Greece
Ioannina, , Greece
Kalamata, , Greece
Kyparissía, , Greece
Lamia, , Greece
Larissa, , Greece
Larissa, , Greece
Livadeia, , Greece
Mytilene, , Greece
Pátrai, , Greece
Rhodes, , Greece
Thessaloniki, , Greece
Thessaloniki, , Greece
Thessaloniki, , Greece
Thessaloniki, , Greece
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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2006-006349-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ML20952
Identifier Type: -
Identifier Source: org_study_id
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