NUTLEY, N.J., April 3 /PRNewswire-FirstCall/ -- CERA (Continuous Erythropoietin Receptor Activator), an investigational anti-anemia agent being developed by Roche, maintained sustained and stable control of hemoglobin levels with dosing intervals of up to four weeks in dialysis patients who suffer from anemia, irrespective of patients’ gender, race, age or diabetic status, according to an analysis of year-long Phase II data.(1) Additionally, the findings showed that dose adjustments for the patient characteristics studied did not appear necessary. The analysis was presented during the American Nephrology Nurses’ Association (ANNA) 37th National Symposium in Nashville, TN. Phase II results with CERA are being confirmed in an extensive Phase III clinical program.
“These results suggest that CERA can maintain stable hemoglobin levels at extended dosing intervals up to once every four weeks, allowing for less frequent dosing,” said Paula Dutka, RN, MSN, CNN, Director, Education/Research, Nephrology Network of Winthrop University Hospital in Mineola, NY. “Less frequent dosing may reduce the amount of time associated with the administration of treatment for anemia.”
Reducing the burden of care is an important goal in the treatment of patients with anemia of chronic kidney disease.(1) Achieving extended dosing intervals for erythropoietic stimulating agents, while maintaining hemoglobin levels within the recommended target range (11g/dL - 12g/dL), may simplify anemia management for patients both on dialysis and not on dialysis.
Study Details
This analysis of two Phase II studies of CERA evaluated the impact of gender, age, race, or diabetic status on maintenance of stable hemoglobin (Hb) levels. In the core periods of the two studies, patients were administered subcutaneous (SC) CERA (once-weekly, once every three weeks or once every four weeks) or IV CERA (once-weekly or once every two weeks). At the end of both studies, patients were eligible to enter 12-month extension studies with the aim of maintaining Hb levels at 11-12g/dl while continuing drug administration route and dose intervals.
The analysis found that CERA maintained Hb levels within the target range levels recommended by K/DOQI Clinical Practice Guidelines for Anemia of Chronic Kidney Disease(2), regardless of the patients’ gender, race, age or diabetic status.(3) Specifically, there were no significant differences in mean Hb levels or CERA dose for men versus women; for patients 18-44 versus those greater than or equal to 45 years of age; for Caucasians versus non- Caucasians; or for diabetic versus non-diabetic patients.
Additionally, the analysis showed that few dose changes were required -- even with extended interval dosing, with the longest administration interval being once every four weeks. In both studies CERA also was generally well tolerated, with the most frequently reported adverse events being hypotension and muscle cramp.
About CERA
CERA is an innovative chemical entity being investigated for the treatment of anemia in chronic kidney disease and anemia associated with chemotherapy in cancer patients. Roche has undertaken the largest phase II - III program ever for a drug treating renal anemia with 10 trials involving more than 2,700 patients. It is currently in Phase III of its development in CKD and Roche plans to file a BLA for CERA in 2006.
About Anemia
Anemia affects up to 90 percent of patients with renal disease from patients with relatively early stage CKD to patients with kidney failure requiring dialysis. Anemia is a condition in which the hemoglobin level in the blood is reduced, either because the red cells containing hemoglobin are reduced in number or because the hemoglobin content in the red cells is abnormally low. Hemoglobin enables red blood cells to carry oxygen throughout the body and reduction in hemoglobin will reduce the oxygen carried to the cells unless the heart increases its output substantially. When the body is starved of the oxygen it requires, extreme fatigue sets in along with dizziness. The increased load on the heart can lead to heart failure and causes increased morbidity and mortality in patients with end-stage kidney disease.
Normally, when the body senses a decrease in red blood cells or a decrease in oxygen, more erythropoietin (a protein produced by the kidneys) is created. This protein stimulates the production of oxygen-carrying red blood cells in the bone marrow which raises the red blood cell count. When this natural mechanism is hindered (as in kidney disease patients), it is necessary to stimulate the receptors to produce red blood cells with agents such as CERA. CERA has different receptor binding characteristics and prolonged serum half-life.
About Roche
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world’s leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years, the Roche Group has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people’s health and quality of life. An employer of choice, in 2005, Roche was named one of Fortune magazine’s Best Companies to Work For in America, one of the Top 20 Employers (Science magazine), ranked as the No. 3 Best Company to Work For in NJ (NJ Biz magazine), the No. 1 Company to Sell For (Selling Power), and one of AARP’s Top Companies for Older Workers. For additional information about the U.S. pharmaceuticals business, visit our websites: http://www.rocheusa.com or http://www.roche.us.
(1) Dutka, Paula. CERA (Continuous Erythropoietin Receptor Activator) Maintains Stable Hemoglobin Concentrations In Dialysis Patients Irrespective of Gender, Age, Race or Diabetic Status. ANNA 37th National Symposium. (2) NKF-K/DOQI Clinical Practice Guidelines for Anemia of Chronic Kidney
Disease: Update 2000. Am J Kidney Disease 77:S182-S288, 2001 (suppl 1) http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids =11229970&dopt=Abstract Guideline 4.
(3) Dutka, Paula. CERA (Continuous Erythropoietin Receptor Activator) Maintains Stable Hemoglobin Concentrations In Dialysis Patients Irrespective of Gender, Age, Race or Diabetic Status. ANNA 37th National Symposium.
Roche
CONTACT: Shelley Rosenstock, Roche, +1-973-562-2373,shelley.rosenstock@roche.com; Diana Scott, Manning Selvage & Lee,+1-212-468-4271, diana.scott@mslpr.com
