A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Effects of Treatment With 2 Regimens of Subcutaneous Darbepoetin Alfa (Weight-based Dosing and Fixed Dosing) on Hemoglobin Concentration Response in Subjects With Symptomatic CHF and Anaemia
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Effects of Treatment With 2 Regimens of Subcutaneous Darbepoetin Alfa (Weight-based Dosing and Fixed Dosing) on Hemoglobin Concentration Response in Subjects With Symptomatic CHF and Anaemia
The purpose of this study is to evaluate whether weight-based or fixed starting doses result in comparable hemoglobin increases and treatment effects in patients with heart failure and anemia.
Inclusion Criteria: - Symptomatic CHF for at least 3 months - Reduced left ventricular ejection fraction - Stable heart failure medication - Hemoglobin concentration between 9.0 and 12.5 g/dL Exclusion Criteria: - Hypertension - Unstable angina pectoris or recent myocardial infarction - Likely to receive cardiac transplant - Major organ transplant (e.g., lung, liver, heart) or in renal replacement therapy (e.g., dialysis) - Recent or current treatment for malignancy - Systemic hematologic disease - Anemia due to acute or chronic bleeding - Recent Epogen® or darbepoetin alfa therapy - Recent blood transfusion