A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.

• Time Spent on Anemia Treatment Over Evaluation Period [ Time Frame: Months 5-7 ] [ Designated as safety issue: No ]
  Efficacy and pharmacoeconomics analyses were not performed.
• Change in Hemoglobin (Hb) Concentration From Baseline to the Average Over the Evaluation Period [ Time Frame: Baseline, Months 5-7 ] [ Designated as safety issue: No ]
  Efficacy and pharmacoeconomics analyses were not performed.

• Number of Participants Assessed for AEs [ Time Frame: Month 1 to 15 day follow up post month 7 ] [ Designated as safety issue: Yes ]
  The adverse events are captured in the adverse event and serious adverse event section of this database.
• The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants [ Time Frame: Baseline, Month 1 to Month 7 ] [ Designated as safety issue: No ]
  A marked laboratory abnormality was defined as a test result that was outside of the marked abnormality range and that also represented a clinically relevant change from baseline of at least a designated amount.

This 2 arm study will compare 'time and motion' (provider time spent on anemia management) and effect on hemoglobin (Hb) levels, of methoxy polyethylene glycol-epoetin beta (Mircera) and epoetin alfa, in anemic patients with chronic kidney disease (CKD) on hemodialysis. Patients stable on intravenous (iv) epoetin alfa will be randomized either to receive standard of care therapy (epoetin alfa (iv) 3 times weekly), or to receive Mircera 120-360 micrograms (iv), monthly. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

• Drug: methoxy polyethylene glycol-epoetin beta
  120-360 micrograms intravenous (iv) monthly, starting dose
  Other Name: Mircera
• Drug: Epoetin alfa
  As prescribed, iv, 3 times weekly

• Experimental: methoxy polyethylene glycol-epoetin beta
  120-360 micrograms (iv) monthly, starting dose
  Intervention: Drug: methoxy polyethylene glycol-epoetin beta
• Active Comparator: Epoetin Alfa
  As prescribed, (iv), 3 times weekly
  Intervention: Drug: Epoetin alfa

Inclusion Criteria:

• adult patients, >=18 years of age;
• CKD (stage V) on outpatient hemodialysis therapy for >= 3 months;
• CKD-related anemia treated with epoetin alfa iv 3x/week for >= 3 months;
• average hemoglobin (Hb) 10-12 g/dL over last 3 months.

Exclusion Criteria:

• failed renal transplant within 12 months prior to screening;
• poorly controlled hypertension;
• previous treatment with Mircera.