A Study of Intravenous Mircera in Participants With Chronic Renal Anemia Who Are on Dialysis
NCT ID: NCT00660023
Last Updated: 2016-03-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
124 participants
INTERVENTIONAL
2008-08-31
2010-11-30
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 previously treated with ESA therapy will receive intravenous Mircera, also known as continuous erythropoietin receptor activator (CERA), every 4 weeks for a total of 52 weeks in this single-arm study. The first dose will be determined by the dose of ESA received prior to administration of study treatment, and subsequent doses will be adjusted to achieve target Hb concentrations.
Methoxy polyethylene glycol-epoetin beta
Participants will receive intravenous CERA/Mircera every month, with starting dose based on previous ESA therapy. Treatment will continue for 52 weeks.
Interventions
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Methoxy polyethylene glycol-epoetin beta
Participants will receive intravenous CERA/Mircera every month, with starting dose based on previous ESA therapy. Treatment will continue for 52 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Chronic renal anemia
* Continuous stable intravenous or subcutaneous maintenance epoetin or darbepoetin therapy during previous month
* Regular long-term hemodialysis therapy with the same mode of dialysis for the previous 3 months
Exclusion Criteria
* Poorly controlled hypertension
* Significant 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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Baja, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Esztergom, , Hungary
Keszthely, , Hungary
Miskolc, , Hungary
Salgótarján, , Hungary
Szolnok, , Hungary
Vác, , Hungary
Zalaegerszeg, , Hungary
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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2006-005621-28
Identifier Type: -
Identifier Source: secondary_id
ML20752
Identifier Type: -
Identifier Source: org_study_id
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