A Study Comparing Mircera and Epoetin Beta for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.
NCT ID: NCT00442793
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
265 participants
INTERVENTIONAL
2007-05-31
2010-05-31
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]
0.4 micrograms/kg iv every 2 weeks
2
Epoetin beta
As prescribed, 3 times weekly
Interventions
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Epoetin beta
As prescribed, 3 times weekly
methoxy polyethylene glycol-epoetin beta [Mircera]
0.4 micrograms/kg iv every 2 weeks
Eligibility Criteria
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Inclusion Criteria
* chronic renal anemia requiring dialysis;
* maintenance hemodialysis or peritoneal dialysis for \>=2 weeks before and during screening;
* adequate iron status.
Exclusion Criteria
* failing renal graft in place;
* bleeding episode necessitating transfusion within 8 weeks prior to screening;
* poorly controlled hypertension;
* previous treatment with Mircera.
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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Beijing, , China
Beijing, , China
Beijing, , China
Chengdu, , China
Guangzhou, , China
Guangzhou, , China
Hangzhou, , China
Nanjing, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Hong Kong, , Hong Kong
Countries
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Other Identifiers
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ML20680
Identifier Type: -
Identifier Source: org_study_id