A Study of Monthly Subcutaneous or Intravenous Mircera in Dialysis Patients With Chronic Renal Anaemia

A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneous and Intravenous MIRCERA® for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia

This open label, single arm study will assess the efficacy for long-term maintenance of haemoglobin levels and the safety and tolerability of methoxy polyethylene glycol-epoetin beta [Mircera] in dialysis patients with chronic renal anaemia. Patients on regular long-term haemodialysis or peritoneal dialysis will receive monthly subcutaneous or intravenous Mircera for 6 months. Target sample size is <200 patients.

Inclusion Criteria:

• adult patients, >/=18 years of age
• chronic renal anaemia
• haemoglobin 10.0-12.0g/dl at screening
• adequate iron status
• continuous stable ESA (erythropoietic stimulating agent) therapy for >/= 2 months
• regular haemodialysis or regular peritoneal dialysis for >/= 3 months

Exclusion Criteria:

• uncontrolled hypertension
• haemoglobinopathy
• anaemia due to haemolysis
• pure red cell aplasia (PRCA)