MIRCERA.com

Phase II maintenance trial data show that MIRCERA® administered intravenously or subcutaneously to patients converting directly from an erythropoiesis-stimulating agent (ESA) maintains stable haemoglobin (Hb) levels within the target range
(11–12 g/dL over the long term [≥1 year]), with administration every 4 weeks.^1,2

 

In the phase III maintenance studies (MAXIMA and PROTOS), patients previously maintaining stable Hb levels with up to 3 times a week epoetin were successfully converted to MIRCERA administered every 4 weeks.^3–6

 

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

 

MAXIMA: Maintenance of haemoglobin excels with IV administration of C.E.R.A.
PROTOS: Patients receiving C.E.R.A. once a month for the maintenance of stable haemoglobin

 

References:

 

1. Besarab A, Salifu MO, Lunde NM, et al.Efficacy and tolerability of intravenous continuous erythropoietin receptor activator: a 19-week, phase II, multicenter, randomized, open-label, dose-finding study with a 12-month extension phase in patients with chronic renal disease. Clin Ther. 2007;29:626–639.
2. 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.
3. Locatelli F, Sulowicz W, Harris K, et al.SC C.E.R.A. (continuous erythropoietin receptor activator) once every 2 weeks or once monthly maintains stable Hb levels after converting directly from IV epoetin 1–3 times per week in patients with CKD on dialysis. J Am Soc Nephrol 2006;17:619A.
4. Fishbane S, Levin NW, Mann JFE, et al. IV C.E.R.A. (continuous erythropoietin receptor activator) once every 2 weeks or once monthly maintains stable Hb levels after converting directly from IV epoetin 1–3 times per week in patients with CKD on dialysis. J Am Soc Nephrol 2006;17:618A (abstract SA-PO205).
5. Mann J, Locatelli F, Sulowicz W, et al. C.E.R.A. provides stable haemoglobin (Hb) levels in CKD patients on dialysis with and without coronary artery disease (CAD) or diabetes mellitus (DM) when administered once monthly. Nephrol Dial Transplant. 2007 In Press (abstract Suo002).
6. Sulowicz W, Locatelli F, Ryckelynck J-P, et al. Once-monthly subcutaneous continuous erythropoietin receptor activator (C.E.R.A.) maintains stable control in patients with chronic kidney disease on dialysis directly converted from epoetin one to three times weekly. Clin J Amer Soc Nephrol. 2007 doi:10.2215/CJN.03631006.