STAAR-3 Clinical Study

- diagnosis of CRI and not receiving dialysis therapy (must be predialysis) - measured or estimated (using the Cockcroft-Gault formula) creatinine clearance (CrCl) of ≤ 70 mL/min, or GFR ≤ 60 mL/min (using the MDRD formula): - Cockcroft-Gault formula: CrCl = (140 minus age in years) x (body weight in kg) serum creatinine (mg/dL) x 72.0. For women, the value will be multiplied by 0.85 - MDRD formula: GFR = 170 x [SCr]-0.999 x [Age]-0.167 x [0.762 if subject is female] x [1.180 if subject is black] x [SUN]-0.170 x [SAlb]-0.318 - (if subject is not already receiving rHuEPO therapy) mean Hgb < 11 g/dL during the screening/baseline period - for subjects currently receiving rHuEPO therapy, the subject must have: a stable rHuEPO dose for the past month; and a rHuEPO frequency of once weekly. - white blood cell and platelet counts within normal limits - serum vitamin B12 and folate levels above the lower limit of normal range - transferrin saturation (TSAT) ≥ 20% during the screening period - availability for follow-up assessments - subject must be able to comprehend and be willing to, or have legally accepted representative, give written informed consent for participation in the study

- scheduled to initiate dialysis - uncontrolled hypertension (diastolic blood pressure > 105 mm Hg or systolic blood pressure of > 180 mm Hg during the screening/baseline period on two separate measurements) - clinically unstable in the judgment of the investigator (eg, subject is in the intensive care unit, immediately post-myocardial infarction, etc) - scheduled to receive a living donor kidney transplant - treatment of grand mal epilepsy within the past 6 months - moderate to severe congestive heart failure (NYHA class III or IV) - clinical evidence of severe secondary hyperparathyroidism (parathyroid hormone level > 1500 pg/mL) - severe active chronic inflammatory process (eg, ulcerative colitis, peptic ulcer disease, rheumatoid arthritis, etc) - currently receiving antibiotic therapy for systemic infection (enrollment may be postponed until the course of antibiotics has ended) - known aspartate aminotransferase (AST) or alanine aminitransferase (ALT) greater than 3 times the upper limit of the normal range on more than one occasion within three months prior to screening - known positive HIV antibody or hepatitis B surface antigen - clinical evidence of current malignancy and/or receiving chemotherapy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia - active bleeding or RBC transfusion within eight weeks of enrollment - androgen therapy within four weeks before enrollment - known hematologic disease (eg, sickle cell anemia, myelodysplastic syndromes, hematologic malignancy, myeloma; hemolytic anemia, etc) - any condition that is likely to affect subject compliance - currently or previously (within 30 days) enrolled in investigational device or drug trial(s) or receiving investigational agent(s) - the exception to this is if the subject was enrolled in another Aranesp™ or rHuEPO protocol - pregnant or breast feeding women (women of child-bearing potential must be using contraceptive precautions) - women planning to have a child during the study period - known hypersensitivity to the active substance or any of the excipients