This 2 arm study will compare the effect on hemoglobin response of Mircera and epoetin beta, in patients with chronic renal anemia who are on dialysis. Eligible patients will be randomized to receive either Mircera (0.4 micrograms/kg i.v. every 2 weeks) or epoetin beta (3 times weekly, according to approved labelling). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
265
As prescribed, 3 times weekly
0.4 micrograms/kg iv every 2 weeks
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
Unnamed facility
Chengdu, China
Hb response rate
Time frame: Weeks 0-24
Change in Hb concentration between baseline and evaluation period
Time frame: Months 4-6
Hb over time
Time frame: Throughout study
Time to Hb response
Time frame: Throughout study
RBC transfusions
Time frame: Weeks 0-24
AEs, laboratory parameters, vital signs
Time frame: Throughout study
Serum concentration of Mircera
Time frame: Throughout study
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Unnamed facility
Guangzhou, China
Unnamed facility
Guangzhou, China
Unnamed facility
Hangzhou, China
Unnamed facility
Nanjing, China
Unnamed facility
Shanghai, China
Unnamed facility
Shanghai, China
...and 4 more locations