First ever study in hemodialysis patients to show stable hemoglobin levels

Nov 1 2004

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:

• Stable Hb levels were maintained in dialysis patients previously treated with epoetin (n=137) when given CERA, with dosing intervals of up to once every 4 weeks.
• Rapid correction of anemia and a sustained Hb response was achieved in ESA naïve patients with chronic kidney disease not on dialysis (n=65) with CERA treatment up to once every 3 weeks.
• CERA was generally well tolerated in both studies.

In a study of dialyzed patients (n=137) on maintenance therapy, CERA was tested for three dose groups in sequence with three dosing intervals (once a week, once every 3 weeks and once every 4 weeks). Patients on dialysis with chronic renal anemia who were treated with subcutaneous epoetin for greater than or equal to 3 months before and during a 2 week run-in period were randomized to three dose groups. After 6 weeks treatment with CERA at the originally assigned dose, individual dose adjustment was permitted for the balance of the study (a further 13 weeks or 15 weeks for patients on the once every 4 week administration schedule).

In the chronic kidney disease study ESA naïve patients (n=65) were randomized after a 2 week run-in period to receive CERA by subcutaneous injection either once weekly, once every 2 weeks or once every 3 weeks. The dose was constant for the first 6 weeks and dose adjustment was allowed in the subsequent 12 weeks of the study.

Recruitment into studies in the CERA phase III renal development programme which began early 2004 is well under way. The programme involves centers around the world, testing both correction and maintenance of anemia.