Amgen Phase 3 Aranesp RED-HF trial fails to meet primary endpoint

17th January 2013 (Last Updated January 17th, 2013 18:30)

Amgen has reported that Phase 3 Aranesp (darbepoetin alfa) RED-HF (reduction of events with darbepoetin alfa in heart failure) trial did not meet the primary endpoint of reducing the composite endpoint of time to death from any cause or first hospital admission for worsening heart failure.

Amgen

Amgen has reported that Phase 3 Aranesp (darbepoetin alfa) RED-HF (reduction of events with darbepoetin alfa in heart failure) trial did not meet the primary endpoint of reducing the composite endpoint of time to death from any cause or first hospital admission for worsening heart failure.

The global, randomised, double-blind, placebo-controlled study is designed to assess the effect of treatment with Aranesp on mortality and heart failure hospitalisation.

Amgen corporate chief medical officer and global development senior vice president Michael Severino said the RED-HF trial was designed to find out if the treatment of anaemia could improve morbidity and mortality in systolic heart failure patients.

"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," Severino added.

Around 2,278 patients with symptomatic systolic heart failure and anaemia were randomised with either Aranesp to achieve a target haemoglobin of at least 13.0g/dL (not to exceed 14.5g/dL), or placebo.

No new safety data was reported in the event-driven study, in which cardiac failure, dyspnea, diarrhoea, congestive heart failure and dizziness were most frequently observed adverse events.

Secondary endpoints of the study include time to death from any cause; time to cardiovascular death or first hospital admission for worsening heart failure, whichever occurs first; change from baseline to month six in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score and change from baseline in KCCQ symptom frequency score.

An independent data monitoring committee reviewed the RED-HF trial data every quarter throughout the length of the trial.


Image: Amgen Phase 3 Aranesp RED-HF trial did not meet key endpoints. Photo: Coolcaesar.