The RED-HF trial failed to meet its primary endpoint of reducing the composite endpoint of time to death from any cause or first hospital admission for worsening heart failure, Amgen announced.
The RED-HF (Reduction of Events With Darbepoetin Alfa in Heart Failure) trial is a randomized, double-blind, placebo-controlled, Phase 3 study designed to evaluate the effect of treatment with darbepoetin alfa (Aranesp) on mortality and heart failure hospitalization. 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 to 12.0 g/dL) were randomized to receive either treatment with darbepoetin alfa to achieve a target hemoglobin of at least 13.0 g/dL (not to exceed 14.5 g/dL), or placebo.
The primary endpoint of the study was the composite of time to death from any cause or first hospital admission for worsening heart failure in patients with symptomatic left ventricular systolic dysfunction and anemia. Secondary endpoints included time to death from any cause; time to cardiovascular death or first hospital admission for worsening heart failure, whichever occurred 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.
Thousand Oaks, Calif.-based Amgen reported there were no new safety findings identified in the study. The most frequently reported adverse events in the study were cardiac failure, dyspnea, diarrhea, congestive heart failure and dizziness. The summary results will be followed by efficacy and safety analyses, which Amgen said will be shared and discussed with global regulatory agencies and submitted for presentation at an upcoming medical meeting.
Aranesp was approved by the FDA in 2001 for the treatment of anemia associated with chronic renal failure (CRF) for patients on dialysis and patients not on dialysis. The European Commission granted marketing authorization for the same indication in 2001 and subsequently updated it for CRF patients with symptomatic anemia in 2008.
In 2002, the FDA approved Aranesp for the treatment of anemia caused by concomitantly administered chemotherapy in patients with non-myeloid malignancies. The European Commission authorized the treatment of anemia caused by concomitantly administered chemotherapy in patients with non-hematological malignancies in 2002 and extended it to include non-myeloid malignancies in patients receiving chemotherapy in 2003.