This two arm study will compare the maintenance of hemoglobin levels, safety and tolerability of once every 4 weeks subcutaneous administration of Mircera versus epoetin beta in dialysis patients with chronic renal anemia. Patients will be randomized to receive either subcutaneous Mircera (starting dose 120, 200 or 360 micrograms) every 4 weeks or subcutaneous epoetin beta in accordance with the prescribed dosing information. In both groups, the starting dose will be the same as the previous dose of epoetin beta administered in the week preceding first study drug administration. Patients will be treated for 28 weeks with follow up 4 weeks after the last treatment visit. 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
281
As prescribed
120, 200 or 360 micrograms every 4 weeks
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
Unnamed facility
Chengdu, China
Unnamed facility
Guangzhou, China
Unnamed facility
Guangzhou, China
Unnamed facility
Hangzhou, China
Unnamed facility
Nanjing, China
...and 3 more locations
Change in hemoglobin concentration between baseline and the EEP
Time frame: Week 20-28
Proportion of patients maintaining average Hb concentration within the target range during the EEP; proportion of patients maintaining Hb concentration between 10-12g/dL throughout the EEP.
Time frame: Weeks 1-28
Mean time spent in the Hb range 10 - 12g/dL; incidence of red blood cell transfusions during the DTP and EEP.
Time frame: Weeks 1-28
Incidence of adverse events and serious adverse events; vital signs, laboratory parameters, ECG.
Time frame: Throughout study
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