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Pivotal MIRCERA(R) Study First to Convert Dialysis Patients From Frequent Dosing Directly to Once Every Two Weeks or Once Every Four Weeks
Date:10/19/2007

y assigned to either of the MIRCERA arms or to continue epoetin alfa or beta at their current dose and administration interval. Patients randomized to MIRCERA received a starting dose based on the previous weekly dose of epoetin.

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

patient population.

About MIRCERA

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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SOURCE Roche
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