A Study of Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia

A Single Arm Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Haemodialysis Patients With Chronic Renal Anaemia.

This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Patients will receive 4-weekly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms. 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;
• continuous stable iv or sc maintenance epoetin therapy during previous 4 weeks;
• regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months.

Exclusion Criteria:

• transfusion of red blood cells during previous 2 months;
• poorly controlled hypertension requiring hospitalization or interruption of epoetin treatment in previous 6 months;
• significant acute or chronic bleeding.