MIRCERA.com

Phase II correction studies demonstrated a dose-dependent effect with MIRCERA®, regardless of administration schedule. Subcutaneous (SC) MIRCERA established a 0.60 µg/kg/2 weeks dose as suitable for initiating correction of renal anaemia in erythropoiesis-stimulating agent (ESA)-naïve patients.^1,2 In the ARCTOS and AMICUS phase III correction studies, MIRCERA achieved responses rates of up to 97.5% and 93.3%, respectively, with fewer excursions over 13 g/dL than epoetin in the first 8 weeks of treatment (ARCTOS: 12% vs 34%, p<0.0001; AMICUS: 8% vs 17%, p=0.095).^3,4

 

Further information on the phase II and phase III correction studies can be found on separate pages in this section.

 

ARCTOS: Administration of C.E.R.A. in CKD patients to treat anaemia with a twice-monthly schedule
AMICUS: C.E.R.A. administered intravenously for anaemia correction and sustained maintenance in dialysis

 

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.
3. Macdougall IC, Walker R, Provenzano R, et al. C.E.R.A. corrects anaemia in patients with chronic kidney disease not on dialysis: Results of a randomized clinical trial. Clin J Am Soc Nephrol. 2007 In press.
4. Klinger M, Aria M, Vargemezis V, et al. Intravnous pegzerepoetin alfa, a continuous receptor activator (C.E.R.A.), administered twice monthly corrects haemoglobin levels in patients with chronic kidney disease on dialysis: results of AMICUS, a randomized prospective study vs epoetin given once to three times weekly. Am J Kidney Dis. 2007 In press.