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

An Open Label Study to Assess the Maintenance of Hemoglobin Levels, Safety and Tolerability of Once Monthly Administration of Mircera in Hemodialysis Patients With Chronic Renal Anemia.

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).