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NeoRecormon Monitoring Schedules in Renal Anemia
NCT00440063Phase 4
Key facts
- Status
- Terminated
- Countries
- 1
- Sponsor
- Roche
- Modality
- Erythropoietins, Colony Stimulating Factors
- Drugs
- epoetin beta
- Conditions
- Anemia In Chronic Kidney Disease
01
Overview
Phase 4, randomised, open-label trial of epoetin beta in Anemia In Chronic Kidney Disease (2 arms), sponsored by Roche. Primary endpoint: Percentage of patients achieving target Hb within 20 weeks. Status: terminated.
02
Design
2 arms- Study design
- RandomizedOpen-label
4-weekly monitoring
Monitoring of Hb and iron parameters every 4 weeks
8-weekly monitoring
Monitoring of Hb and iron parameters every 8 weeks
03
Endpoints
Primary
Percentage of patients achieving target Hb within 20 weeks
Secondary
Percentage of patients exceeding upper Hb target
Percentage of patients who fail to reach target Hb
Median time to achieve Hb target
Dose of NeoRecormon required to meet target Hb concentration
Percentage of patients who maintain target iron parameters
Adverse Events
Serious Adverse Events
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