Roche’s new anti-anemia agent continuous erythropoietin receptor activator (CERA) was able to control anemia in patients with chronic kidney disease (CKD) not on dialysis within a narrow target range set out in expert guidelines for more than one year.

The Phase II extension data was presented at November’s American Society of Nephrology 38th Annual Meeting & Scientific Exposition in Philadelphia. Phase II results with CERA are being confirmed in an extensive Phase III clinical program.

“CERA provided consistent and reliable hemoglobin levels in a controlled manner that resembles how the body naturally regulates itself,” said lead investigator Robert Provenzano, MD. “The current guidelines for anemia management, including those in the US, recommend that CKD patients be kept in an optimal range between 11 to 12 g/dL and CERA achieved this at extended dosing intervals. This is important news, as maintaining a patient in this range is difficult; recent reports have pointed out that many patients’ hemoglobin levels fluctuate with excursions outside of this target range. CERA would be the first agent with demonstrated effectiveness at dosing intervals as long as three to four weeks. This is expected to substantially facilitate anemia management for physicians and patients, while allowing Hb levels to remain on target with fewer interventions.”

Anemia (a lower than normal number of red blood cells) is a common comorbidity in CKD patients but is under-diagnosed and under-treated in the early, pre-dialysis stages of this progressive illness. The need to treat anemia in this patient population is gaining recognition as anemia has been linked to the development of cardiovascular disease and acceleration of the progression of kidney disease. 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.

For additional information about this study, please visit Roche’s Web site by clicking here.

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