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Two phase II correction studies investigated dosing levels, routes and schedules of MIRCERA® administration. These studies established starting doses of 0.60 µg/kg/2 weeks subcutaneously for the phase II correction studies and, more importantly, provided feasibility of extended administration of MIRCERA.^1,2 The study results also demonstrated a dose-dependent effect with MIRCERA that was independent of dosing schedule.^1,2

In erythropoiesis-stimulating agent (ESA)-naïve patients not on dialysis, increases in haemoglobin (Hb) levels were comparable regardless of dosing schedule^.2 The mean change in Hb levels from baseline over 6 weeks were:²

• 0.98 g/dL with once-weekly dosing
• 0.85 g/dL with dosing every 2 weeks
• 0.93 g/dL with dosing every 3 weeks.

ANCOVA analysis found no statistically significant differences between dosing schedules (p=0.92). Similar results were obtained in ESA-naïve patients on dialysis^.1 This data provided early evidence of the efficacy of MIRCERA with extended dosing.

Mean increase in haemoglobin level at 6 weeks in erythropoiesis-stimulating agent-naïve patients not on dialysis receiving MIRCERA once per week, every 2 weeks or every 3 weeks.²

References:

1. de Francisco ALM, Sulowicz W, Klinger M, et al. Continuous erythropoietin receptor activator (C.E.R.A.) administered at extended administration intervals corrects anaemia in patients with chronic kidney disease on dialysis: a randomised, multicentre, multiple-dose, phase II study. Int J Clin Pract. 2006;60:1687¬–1696.
2. Provenzano R, Besarab A, Macdougall IC, et al. The continuous erythropoietin receptor activator (C.E.R.A.) corrects anaemia at extended administration intervals in patients with chronic kidney disease not on dialysis:results of a phase II study. Clin Nephrol. 2007;67:306–317.