Strategies Using Darbepoetin Alfa to Avoid Transfusions in Chronic Kidney Disease

Key Inclusion Criteria: * Clinical history of advanced CKD not on dialysis with at least 1 historic estimated glomerular filtration rate (eGFR) \< 45.0 mL/mi)/1.73 m2 at least 12 weeks prior to screening * Not currently receiving dialysis with an eGFR \< 45.0 mL/min/1.73m2, per the central laboratory during screening * Chronic anemia due to renal failure * Two Hb concentrations \< 10.0 g/dL, at least 2 weeks apart during screening using the modified Hb point of care (POC) device * Iron replete, defined as a transferrin saturation (TSAT) ≥ 20% and a ferritin ≥ 100 ng/mL, per the central laboratory during screening * Vitamin B12 and folate replete, defined as a vitamin B12 level \> 180 pg/mL and a folate concentration \> 7 nmol/L, per the central laboratory during screening * Clinically stable in the opinion of the investigator * Subject has provided written informed consent Key Exclusion Criteria: * Systemic hematologic disease (eg, sickle cell anemia, myelodysplastic syndrome, hematologic malignancy) * Current or prior malignancy within 5 years of screening, with the exception of non-melanoma skin cancers and cervical intraepithelial neoplasia * Treatment for any malignancy (eg, radiation, chemotherapy, hormone therapy, or biologics) within 5 years of screening, with the exception of locally excised non-melanoma skin cancer or cervical intraepithelial neoplasia * Female subject not willing to use highly effective methods of birth control during treatment and for 4 weeks af…