Phase II
The objective of the phase II maintenance studies was to determine optimal dose ratios and administration schedules for converting patients on dialysis from treatment with an erythropoiesis-stimulating agent (ESA) to MIRCERA®.
A significant dose-dependent effect (p<0.0001), was observed in patients who were converted directly from epoetin one to three times per week to subcutaneous (SC) MIRCERA.1 During a 12 month extension period, target haemoglobin (Hb) levels were maintained with all dosing schedules.1 The effect of MIRCERA was independent of administration schedule (p=0.36), with adjusted mean change in Hb levels of:
- -0.02 g/dL with once-weekly dosing
- 0.18 g/dL with dosing every 3 weeks
- -0.23 g/dL with dosing every 4 weeks (once-monthly).1
These preliminary data suggested that, in dialysis patients converting directly from an ESA, MIRCERA therapy provides sustained and stable control of Hb within the guideline ranges with once-monthly dosing intervals.
References:
1. Locatelli F, Villa G, de Francisco ALM, et al. Effect of C.E.R.A. on stable haemoglobin in patients with chronic kidney disease on dialysis. Curr Med Res Opin. 2007;23:969–979.