Birmingham,
Alabama
35211
Purpose:
This study will assess the efficacy and safety of intravenous Mircera, given as maintenance
treatment for renal anemia in chronic kidney disease patients on dialysis who were
previously receiving iv epoetin. The anticipated time on study treatment is 1-2 years and
the target sample size is 100-500 individuals.
Criteria:
Inclusion Criteria:
- adult patients >=18 years of age;
- chronic renal anemia;
- on dialysis therapy for at least 12 weeks before screening;
- receiving IV epoetin for at least 8 weeks before screening.
Exclusion Criteria:
- women who are pregnant, breastfeeding or using unreliable birth control methods;
- administration of another investigational drug within 4 weeks before screening, or
during the study period.