In contrast to previous studies in which dialysis patients were converted from IV epoetin using sequential increases in dosing intervals, most patients in MAXIMA were converted directly from a predominantly three-times-a-week regimen of epoetin (87 percent of patients) to IV MIRCERA administered once every two weeks or once every four weeks.
MAXIMA Study Findings
The MAXIMA results showed:
-- Minute changes in Hb levels throughout the duration of the study (mean
changes from the baseline to the evaluation periods were -0.71, -0.25,
and -0.75 g/L in the MIRCERA once every two weeks; MIRCERA once every
four weeks and epoetin groups, respectively), illustrating that the
primary efficacy parameter (mean change in Hb level between baseline
and evaluation periods) was met.
-- For the secondary analysis, the proportion of patients maintaining a
mean Hb within plus or minus 10 g/L of baseline was 68 percent, 68
percent, and 67 percent in the MIRCERA once every two weeks and MIRCERA
once every four weeks and epoetin groups, respectively.
-- The most common serious adverse events in the three groups were sepsis,
pneumonia and arteriograft thrombosis. A similar incidence of adverse
events occurred across all treatment arms with the most frequent
adverse events mild to moderate and had a distribution typical for this
The clinical program for MIRCERA consisted of 10 global studies
involving more than 2,700 patients from 29 countries. The Phase III program
for MIRCERA included two correction studies and four maintenance studies
exploring intravenous (IV) and subcuta
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