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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

- MAXIMA findings in The Lancet affirm the maintenance of hemoglobin levels

with less frequent dosing -

NUTLEY, N.J., Oct. 19 /PRNewswire/ -- A pivotal study published today in The Lancet has shown that dialysis patients were effectively switched from frequently-dosed anemia drugs to an innovative investigational anemia treatment, MIRCERA(R), administered up to once every four weeks(1)

The MAXIMA study is the first randomized, comparative study to investigate the direct conversion of dialysis patients with chronic kidney disease from treatment with erythropoiesis-stimulating agents (ESA) given one to three times a week to IV MIRCERA administered once every two weeks or once every four weeks. The results demonstrated that MIRCERA maintained hemoglobin (Hb) concentrations within the target range as effectively as ESAs epoetin alfa or beta, which are typically given three times a week.

"Our findings demonstrate that MIRCERA was administered up to once every four weeks in hemodialysis patients without sacrificing hemoglobin stability," said Nathan Levin, M.D., Medical and Research Director, Renal Research Institute, New York, New York, and the lead author of the publication. "We note in The Lancet that these results should be generalizable to the maintenance hemodialysis population and that we believe this drug should be an option to epoetin for simplified anemia management."

About the MAXIMA Study

The MAXIMA study randomized 673 adult patients with stable chronic renal anemia on dialysis therapy and IV maintenance epoetin at 91 centers in eight countries. Most patients were from North America (U.S. - 68 percent; Canada - 11 percent) and Europe (21 percent). The study compared two administration intervals of IV MIRCERA (once every two weeks or once every four weeks) with continued IV epoetin treatment (one to three-times a week) in patients with chronic renal anemia. After a run-in period, patients were randoml
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SOURCE Roche
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