A Study of Mircera (C.E.R.A.) in Patients With Pre-Dialysis Chronic Renal Anemia
Summary
This single arm, open label, multicenter study will evaluate the safety and change in hemoglobin levels of Mircera (C.E.R.A.; methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia who are not on dialysis. Patients will receive as a recommended starting dose 1.2 micrograms of Mircera subcutaneously every 4 weeks. The starting dose is dependent on the patient's weight. Dose adjustment may be required due to inadequate or excessive treatment response. The anticipated time on study treatment is 28 weeks.
Timeline
- Start
- 2011-07-18
- Primary completion
- 2012-11-30
- Completion
- 2012-11-30
Outcome
Met primary endpoint
registry analysis (superiority or other test); Methoxy Polyethylene Glycol-Epoetin Beta; p <0.0001; Paired t-test NCT01342640 ↗
registry analysis (superiority or other test); Methoxy Polyethylene Glycol-Epoetin Beta; p <.0001; Paired t-test NCT01342640 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 1.2 ug/kg | Subcutaneous |