Dataset from A Randomized, Controlled, Open-Label, Multi-Centre, Parallel-Group Study To Assess All-Cause Mortality And Cardiovascular Morbidity In Patients With Chronic Kidney Disease On Dialysis And Those Not On Renal Replacement Therapy Under Treatment With MIRCERA® Or Reference ESAs.

This 2 arm safety study will compare the outcome with respect to a composite endpoint of
all-cause mortality and non-fatal cardiovascular events (myocardial infarction, stroke) in
CKD participants either on dialysis or not receiving renal replacement therapy under
treatment with methoxy polyethylene glycol-epoetin beta or reference ESAs. Participants will
be randomized to receive intravenous (iv) or subcutaneous (sc) methoxy polyethylene
glycol-epoetin beta at the following doses: for participants not already receiving ESA
treatment, methoxy polyethylene glycol-epoetin beta will be administered at a starting dose
of 0.6 micrograms per kilograms every 2 weeks (mcg/kg/2wks) iv or sc; for participants
receiving maintenance ESA treatment, iv or sc methoxy polyethylene glycol-epoetin beta will
be administered at an initial monthly dose of 120, 200 or 360 micrograms (mcg) depending on
the weekly dose of ESA received prior to first methoxy polyethylene glycol-epoetin beta
administration. Participants randomized to reference ESA treatment will receive iv or sc ESAs
in accordance with their prescribed dosing information.