Amgen's phase 3 Aranesp (darbepoetin alfa) trial that sought to reduce hospital and time to death in heart failure patients did not reach its endpoint. The company announced top-line results of the RED-HF (Reduction of Events With Darbepoetin Alfa in Heart Failure) study Jan. 16.
"The RED-HF Trial was designed and powered to evaluate whether the treatment of anemia could improve morbidity and mortality in systolic heart failure patients," said Michael Severino, MD, senior vice president of global development and corporate chief medical officer at Amgen. "While the study did not meet its key endpoints, we thank the patients and investigators who participated in RED-HF and helped answer this important question."
The trial was initiated in 2006, and a total of 2,278 patients with symptomatic systolic heart failure and anemia (hemoglobin levels ranging from 9.0-12.0 g/dL) were randomized to receive either treatment with Aranesp to achieve a target hemoglobin of at least 13.0 g/dL (not to exceed 14.5 g/dL), or placebo.
There were no new safety findings identified in the study, Amgen said.