At a glance
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A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia
In Brief
A Phase 3 clinical trial evaluating methoxy polyethylene glycol-epoetin beta [Mircera] for Anemia. Completed, enrolled 188 participants across 24 sites.
Detailed Summary
This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in dialysis participants with chronic renal anemia. Participants will receive monthly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms, according to the dose of epoetin administered in the week preceding first study drug administration. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Study Details
Timeline
Interventions
120, 200 or 360 micrograms iv monthly (starting dose)