RED-HF™ Trial - Reduction of Events With Darbepoetin Alfa in Heart Failure Trial

Several epidemiological studies have demonstrated an association between HF and anemia and
correlation of increased risk for mortality and hospitalization with low hemoglobin in
patients with HF. Earlier single-center interventional studies suggest that meaningful
clinical benefits may be achieved by raising hemoglobin concentration in patients with
symptomatic HF and anemia. Data from Amgen's completed phase 2 multi-center studies support
this hypothesis and show that darbepoetin alfa is well tolerated in patients with symptomatic
left ventricular systolic dysfunction and anemia and effectively raises hemoglobin. The
pivotal phase 3 Study 20050222 RED-HF Trial is evaluating the effect of treatment with
darbepoetin alfa on the composite risk of all-cause mortality or hospitalization for
worsening HF in patients with symptomatic left ventricular systolic dysfunction and anemia.
This study also evaluates the effect of darbepoetin alfa treatment on all-cause death, on
cardiovascular death or hospitalization for worsening HF, and on patient-reported
quality-of-life outcomes.

Inclusion Criteria:

- Heart failure of at least 3 months duration and of New York Heart Association (NYHA)
class II, III, or IV

- hemoglobin between 9.0 g/dL and 12.0 g/dL

- left ventricular ejection fraction equal to or less than 40%

Exclusion Criteria:

- Transferrin saturation (Tsat) < 15%

- Blood pressure > 160/100 mm Hg

- Heart failure primarily due to valvular heart disease or clinically significant
valvular heart disease that might lead to surgical correction within 12 months of
randomization

- Recipient of a major organ transplant or receiving renal replacement therapy

- Serum creatinine > 3.0 mg/dL (> 265 µmol/L)