Roche's CERA stabilizes anemia in renal patients not on dialysis, study shows

By Angela McDaniels

Seattle, Nov. 14 - Roche said phase 2 clinical data shows its anti-anemia agent CERA was able to control anemia in patients with chronic kidney disease not on dialysis for more than one year.

The 19-week, multicenter study monitored 51 patients over a 54-week period, the company said.

CERA was administered subcutaneously once weekly, once every two weeks or once every three weeks with the aim of maintaining hemoglobin levels at 11 to 12 g/dL.

During the study period, mean monthly hemoglobin levels were 11.3 g/dL with once-weekly use, 11.4 g/dL with once-every-two-week use and 11.7 g/dL with once-every-three-week use, the company said.

"CERA provided consistent and reliable hemoglobin levels in a controlled manner that resembles how the body naturally regulates itself," lead investigator Robert Provenzano of St. John Hospital and Medical Center in Detroit said in a company news release.

The phase 2 data was presented at the American Society of Nephrology 38th Annual Meeting and Scientific Exposition - Renal Week meeting in Philadelphia on Monday.

Phase 2 results with CERA are being confirmed in a phase 3 clinical program, the company said.

Based in Basel, Switzerland, Roche develops pharmaceuticals and diagnostics.

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