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First ever study in hemodialysis patients to show stable hemoglobin levels

Published on November 1, 2004 at 6:42 AM · No Comments

New data confirm that subcutaneous injection of the innovative new anti-anemia agent CERA (Continuous Erythropoietin Receptor Activator) delivers rapid, sustained and stable correction of anemia in a broad spectrum of patients with chronic kidney disease at dosing intervals of up to 4 weeks.

The results were presented during the 37th annual meeting of the American Society of Nephrology (ASN) 29th October - 1st November 2004 in St Louis, USA.

"CERA has a unique activity at the receptor and has been designed to provide sustained stimulation of erythropoiesis with long dosing intervals. It is therefore very satisfying to see proof of this concept in these key clinical studies where CERA produced a rapid, stable and sustained control of Hb levels with dosing intervals of up to once every 4 weeks," commented Dr. Robert Provenzano, Chair, Division of Nephrology, St. John Hospital and Medical Center, Detroit, Michigan and a CERA investigator. He added, "This more closely mimics the body's natural control of red blood cell production. The value of these results for both patients and healthcare providers is that CERA appears to have the potential to offer flexibility and convenience so reducing the burden of anemia management."

Two populations of kidney patients, Erthyropoiesis Stimulating Agent (ESA) naïve with chronic kidney disease not on dialysis and dialysis patients previously treated with epoetin, benefited from CERA. Both studies reported at the ASN were Phase II dose-finding, open-label, randomized, multicenter studies. Key results included:

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