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news.New phase III data show that Roche's investigational treatment Cera was as effective as existing medications when dosed less frequently for renal anemia in patients with chronic kidney disease.
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In these studies, Cera dosed every two weeks achieved as effective a response rate for correcting renal anemia as currently approved, more frequently-dosed agents, including Amgen’s Aransep.
Amgen has disputed the value of the results, however, commenting that Roche selected relatively healthy patients for the trial.
Renal anemia is a common and debilitating complication of chronic kidney disease that is characterized by a low concentration of hemoglobin (Hb) in the blood. Inadequate Hb levels deprive the body’s tissues of oxygen and can lead to serious cardiovascular complications and even death if left untreated.
In the trial, the response rate for patients not on dialysis was 97.5% for Cera and patients on dialysis receiving Cera achieved a response rate of 93.3%, indicating that Cera was effective in correcting Hb levels with a once every two weeks dosing regimen.
“Effective elevation and predictable control of hemoglobin are key to managing renal anemia,” said Robert Provenzano, from the division of nephrology at St John Hospital and Medical Center.