A Study for Monthly Methoxy Polyethylene Glycol-Epoetin Beta Treatment in Patients With Chronic Renal Anaemia

A Single Arm Open Label Interventional Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous Methoxy-polyethylene Glycol-epoetin Beta for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia

This open-label single-arm study will evaluate the efficacy, safety and tolerability of methoxy polyethylene glycol epoetin beta on long-term maintenance of haemoglobin levels in patients with chronic renal anaemia. Patients will receive methoxy polyethylene glycol-epoetin beta intravenously once monthly at initial doses of either 120 micrograms or 200 micrograms or 360 micrograms in the titration phase of 16 weeks with a potential dose adjustment in the evaluation phase of 8 weeks. The anticipated time on study treatment is 24 weeks. The target sample size is 50-100 patients.

Inclusion Criteria:

• Adults >/=18 years of age
• Chronic renal anaemia
• Haemoglobin concentration between 10 and 12 g/dL at screening
• Adequate iron status
• Continuous intravenous maintenance short-acting therapy with same dosing interval for 8 weeks prior to screening
• Regular long-term haemodialysis therapy for at least 12 weeks prior to screening

Exclusion Criteria:

• Change in haemoglobin concentration >/=2 g/dL during screening
• Transfusion of red blood cells less than 8 weeks prior to screening
• Poorly controlled hypertension
• Relevant acute or chronic bleeding requiring treatment less than 8 weeks prior to screening
• Active malignant disease
• Haemolysis
• Haemoglobinopathies