A Study of Once-Monthly Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia.

• Change in Hb concentration between reference and evaluation period; mean time spent in, and percentage of patients maintaining Hb within target range [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]
• Dose adjustments; RBC transfusions [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
• AEs, laboratory parameters, vital signs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

This single arm study will assess the long-term maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in hemodialysis patients with chronic renal anemia. Patients currently receiving darboepoetin alfa or epoetin alfa maintenance treatment will receive intravenous Mircera at a starting dose of 120, 200 or 360 micrograms/4 weeks (based on the ESA dose administered on week-1). Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10.5-12.5g/dL. 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 therapy with the same mode of dialysis for >=3 months;
• continuous iv or sc maintenance ESA treatment during previous 2 months.

Exclusion Criteria:

• transfusion of red blood cells during previous 2 months;
• significant acute or chronic bleeding, such as overt gastrointestinal bleeding;
• active malignant disease (except non-melanoma skin cancer).