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Mircera in chronic renal anemia not on dialysis
NCT01342640Phase 4
Key facts
- Status
- Completed
- Start
- Jul 2011
- Primary completion
- Nov 2012
- Countries
- 1
- Sponsor
- Roche
- Modality
- rProtein (Recombinant Protein), Biologic
- Conditions
- anemia of chronic kidney disease (CKD-A)
01
Overview
Phase 4, open-label, single-arm trial of methoxy polyethylene glycol-epoetin beta in anemia of chronic kidney disease (CKD-A), sponsored by Roche. Primary endpoint: Change From Baseline in Mean Hb Concentration at 28 weeks. Started Jul 2011; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Single Arm
Mircera monotherapy
03
Who it enrols
Adult patients with chronic renal anemia not on dialysis, Hb < 10 g/dL, eGFR 20-60 mL/min, no recent ESA or transfusion.
04
Endpoints
Primary
Change From Baseline in Mean Hb Concentration
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