Safety, PD & PK of Multiple Doses of Peginesatide for Anemia in Chronic Kidney Disease Patients

Inclusion Criteria: Participant is informed of the investigational nature of this study and has given written, witnessed informed consent in accordance with institutional, local and national guidelines; Males or females ≥ 18 and ≤ 85 years of age. Pre-menopausal females (with the exception of those who are surgically sterile) must have a negative pregnancy test at screening; those who are sexually active must practice an adequate form of contraception for at least 4 weeks prior to study start, and must be willing to continue contraception for at least 4 weeks after the last dose of study drug; Chronic kidney disease stage 3 or 4 (estimated Glomerular filtration rate [GFR] of 15-60 mL/min within 28 days prior to study drug administration) and not expected to begin dialysis for at least 12 weeks; Two hemoglobin values of ≥ 9.0 and < 11.0 g/dL within 14 days prior to study drug administration, including at least one of the values drawn within 7 days prior to study drug administration; One serum ferritin level ≥ 100 micrograms per liter (μg/L) and transferrin saturation ≥ 20 % within 4 weeks prior to study drug administration; One serum or red cell folate level above lower limit of normal within 4 weeks prior to study drug administration; One vitamin B12 level above lower limit of normal within 4 weeks prior to study drug administration; Weight ≥ 45 kg within 4 weeks prior to study drug administration; One white blood cell count ≥ 3.0 x 10^9/L within 4 weeks prior to study drug administration; and One platelet count ≥ 100 x 10^9/L within 4 weeks prior to study drug administration. Exclusion Criteria: Prior treatment with any erythropoiesis stimulating agent in the 12 weeks prior to study drug administration; Any prior treatment with Eprex®; Known intolerance to any erythropoiesis stimulating agent; History of antibodies to any erythropoiesis stimulating agent or history of pure red cell aplasia; Prior hemodialysis or peritoneal dialysis treatment; Known intolerance to parenteral iron supplementation; Red blood cell transfusion within 12 weeks prior to study drug administration; Hemoglobinopathy [e.g., homozygous sickle-cell disease (sickle-cell trait does not exclude patient), thalassemia of all types, etc.]; Known hemolysis; Chronic, uncontrolled, or symptomatic inflammatory disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.); C Reactive Protein (CRP) greater than 30 mg/L within the 4 weeks prior to study drug administration; Febrile illness within 7 days prior to study drug administration; Uncontrolled or symptomatic secondary hyperparathyroidism; Poorly controlled hypertension within 4 weeks prior to study drug administration, per Investigator's clinical judgment (e.g. systolic ≥ 170mm Hg, diastolic ≥ 100 mm Hg on repeat readings); Epileptic seizure in the 6 months prior to study drug administration; Chronic congestive heart failure (New York Heart Association Class IV); High likelihood of early withdrawal or interruption of the study; Evidence of malignancy within the past 5 years (except non-melanoma skin cancer which is not an exclusion criterion); Life expectancy < 12 months; Anticipated elective surgery during the study period; and Previous exposure to any investigational agent within 6 weeks prior to administration of study drug or planned receipt during the study period.