Efficacy Study: Darbepoetin Alfa for the Treatment of Anemia in Patients With Chronic Kidney Disease

Inclusion Criteria: - Diagnosis of CKD and receiving hemodialysis for greater than or equalto 3 months before enrollment - No prior exposure to EPREX® or NeoRecorman® - Baselinehemoglobin (Hb) between 10 and 13 g/dL - On stable weekly or once every other weekintravenous (IV) or subcutaneous (SC) darbepoetin therapy for at least 6 weeks prior toscreening (stable is defined as less than 25% change in weekly dose and no change infrequency) - Adequate iron stores (serum ferritin equal to or greater than 100 mg/L) -Before any study-specific procedure, the appropriate written informed consent must be

obtained Exclusion Criteria: - Scheduled to receive a kidney transplant - Uncontrolledhypertension, defined as a pre-dialysis systolic blood pressure (BP) greater than 180and/or diastolic BP of greater than 110 - Acute myocardial ischemia; hospitalization forcongestive heart failure, myocardial infarction, deep vein thrombosis, cerebrovascularevent (stroke or transient ischemic attack) within 12 weeks before enrollment - Parathyroidhormone (PTH) level greater than 1500 pg/mL - Major surgery within 12 weeks beforeenrollment (excluding vascular access surgery) - Currently receiving antibiotic therapy forsystemic infection - Known positive HIV antibody or positive hepatitis B surface antigen -Clinical evidence of current malignancy and/or receiving systemic chemotherapy/radiotherapywith the exception of basal cell or squamous cell carcinoma of the skin and cervicalintraepithelial neoplasia - Red blood cell (RBC) transfusions within 8 weeks beforeenrollment - Androgen therapy within 8 weeks before enrollment - Systemic hematologicdisease (e.g., sickle cell anemia, myelodysplastic syndromes, hematologic malignancy;myeloma; hemolytic anemia) - Any disorder that may impact (in the judgment of theinvestigator) the ability to give informed consent for participation in this study -Pregnant or breast-feeding women. All subjects must practice adequate contraception (in thejudgment of the investigator) throughout this trial. - Treatment with an investigationalagent or device within 30 days before enrollment or scheduled to receive an investigationalagent other than those specified by this protocol during the course of this study - Subjecthas known sensitivity to any of the products to be administered during dosing.