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

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.