Peginesatide for Maintenance Treatment of Anemia in Participants on Hemodialysis

Exclusion Criteria

• •Pregnant or breast-feeding participants
• •Known intolerance to any erythropoiesis stimulating agent, parenteral iron supplementation or pegylated molecules
• •History of antibodies to any erythropoiesis stimulating agent or history of pure red cell aplasia (PRCA)
• •Known bleeding or coagulation disorder
• •Known hematologic disease (e.g., homozygous sickle-cell disease, thalassemia of all types, multiple myeloma, hemolytic anemia)
• •Uncontrolled or symptomatic inflammatory disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.)
• •Known history of seizure disorder or received anti-epileptic medication within the previous 6 months
• •Uncontrolled or symptomatic secondary hyperparathyroidism, per Investigator's clinical judgment
• •Poorly controlled hypertension within 4 weeks prior to study start, per Investigator's clinical judgment
• •Chronic congestive heart failure of New York Heart Association class III or IV
• •High likelihood of early withdrawal or interruption of the study (e.g., myocardial infarction, severe or unstable coronary artery disease, stroke, respiratory, autoimmune, neuropsychiatric, or neurological abnormalities, liver disease including active hepatitis B or C, active HIV disease, or any other clinically significant medical diseases or conditions in the prior 6 months that may, in the Investigator's opinion, interfere with safety, assessment, or follow-up of the participant)
• •Evidence of malignancy within the past 5 years (except non-melanoma skin cancer which is not an exclusion criterion)
• •Life expectancy \< 12 months
• •Temporary (untunneled) dialysis access catheter
• •Anticipated elective surgery during the study period, that may be expected to lead to significant blood loss, including vascular access surgery such as an arteriovenous fistula or graft, or a scheduled kidney transplant
• •Red blood cell or whole blood transfusion within 12 weeks prior to study start
• •Received antibiotics for systemic infection within 2 weeks prior to study start
• •Previous exposure to any investigational agent within 6 weeks prior to study start, or planned receipt of an investigational agent, other than as specified by this protocol, during the study period