A Study of Once Monthly Subcutaneous Mircera in Dialysis Patients With Chronic Renal Anemia

• Change in hemoglobin concentration between reference (SVP) and the EEP [ Time Frame: Weeks 1-24 ] [ Designated as safety issue: No ]
• Proportion of patients maintaining hemoglobin concentration within the hemoglobin range 10.5-12.5g/dL throughout the EEP [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]
• Mean time spent in hemoglobin range of 10.5-12.5g/dL [ Time Frame: Every 2 weeks ] [ Designated as safety issue: No ]
• Adverse events, laboratory parameters [ Time Frame: At planned visits, to week 48 ] [ Designated as safety issue: No ]

This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia.Patients will receive subcutaneous Mircera at a starting dose of 120 or 200 micrograms every 4 weeks, calculated from the last weekly dose of epoetin or darbepoetin alfa previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Inclusion Criteria:

• adult patients >=18 years of age;
• chronic renal anemia;
• regular long-term hemodialysis or peritoneal dialysis, with same mode of dialysis for >=3 months;
• continuous iv maintenance epoetin alfa therapy with same dosing interval during previous 2 months.

Exclusion Criteria:

• transfusion of red blood cells during previous 2 months;
• poorly controlled hypertension;
• significant acute or chronic bleeding;
• active malignant disease (except non-melanoma skin cancer).