RED-HF Trial Design
The RED-HF Trial is a large, event-driven, global, randomized, double-blind, placebo-controlled, Phase 3 study designed and powered to evaluate the effect of treatment with Aranesp on mortality and heart failure hospitalization. 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 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 6 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score; and change from baseline in KCCQ Symptom Frequency Score.
Patients with New York Heart Association (NYHA) class II, III or IV heart failure, left ventricular ejection fraction less than or equal to 40 percent, and hemoglobin greater than or equal to 9.0 g/dL and less than or equal to 12.0 g/dL were randomized 1:1 to receive subcutaneous Aranesp or placebo. The dose of Aranesp was titrated to gradually achieve and maintain a hemoglobin concentration of at least 13.0 g/dL, not to exceed 14.5 g/dL. Investigational product was administered initially every two weeks and extended to every month when patients were stable in the hemoglobin target range. The RED-HF Trial was monitored by an independent Data Monitoring Committee, which reviewed the study data on a quarterly basis throughout the duration of the trial.
Aranesp was approved by the U.S. Food and Drug Administration (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.