• Mean change in Hemoglobin between Baseline and the evaluation period. [ Time Frame: Weeks 20, 21, 22, 23, 24 and 25. ] [ Designated as safety issue: No ]
  

• Proportion of subjects who have mean Hemoglobin values within the target range of 10.0 to 12.0 g/dL during the evaluation period [ Time Frame: Weeks 20, 21, 22, 23, 24 and 25. ] [ Designated as safety issue: No ]
  
• Proportion of subjects with a change in Hemoglobin between Baseline and the evaluation period of ≤ ± 1g/dL. [ Time Frame: Weeks 20, 21, 22, 23, 24 and 25. ] [ Designated as safety issue: No ]
  
• Proportion of subjects who receive red blood cell transfusions during the Titration Period and the Evaluation Period. [ Time Frame: Weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 20, 21, 22, 23, 24 and 25. ] [ Designated as safety issue: No ]
  
• Mean Hemoglobin during 4-week intervals. [ Time Frame: Weeks 1 through 4, 5 through 8, 9 through 12, 13 through 16, 17 through 20, and 21 through 24. ] [ Designated as safety issue: No ]
  
• Proportion of subjects who maintain a target Hemoglobin of 10.0 to 12.0 g/dL during 4-week intervals. [ Time Frame: Weeks 1 through 4, 5 through 8, 9 through 12, 13 through 16, 17 through 20, and 21 through 25. ] [ Designated as safety issue: No ]
  
• Proportion of subjects requiring dose adjustments during the study. [ Time Frame: Weeks 1 trhough 25. ] [ Designated as safety issue: No ]
  
• Adverse events and serious adverse events. [ Time Frame: Weeks 1 through 25. ] [ Designated as safety issue: Yes ]
  
• Physical examination (dry weight). [ Time Frame: Weeks: 0, 13 and 25. ] [ Designated as safety issue: Yes ]
  
• Physical examination (vital signs and oral temperature). [ Time Frame: Weeks: 0, 1 5, 9, 13, 17, 21 and 25. ] [ Designated as safety issue: Yes ]
  
• Clinical laboratory tests (chemistry panel, hematology). [ Time Frame: Weeks: 0, 1, 5, 9, 13, 17, 21 and 25. ] [ Designated as safety issue: Yes ]
  
• Clinical laboratory tests (hemoglobin). [ Time Frame: Weeks 1 through 25. ] [ Designated as safety issue: Yes ]
  
• Composite safety endpoints (death [all causes], stroke, myocardial infarction, congestive heart failure, unstable angina and arrhythmia). [ Time Frame: Weeks 1 through 25. ] [ Designated as safety issue: Yes ]
  
• Proportion of subjects with confirmed (2 consecutive values) hemoglobin outside the range of 10.0 to 12.0 g/dL. [ Time Frame: Weeks 1 through 25. ] [ Designated as safety issue: Yes ]
  
• Proportion of subjects with confirmed (2 consecutive values) hemoglobin values ≥12.0 g/dL, ≥13.0 g/dL, and ≥14.0 g/dL. [ Time Frame: Weeks 1 through 25. ] [ Designated as safety issue: Yes ]
  
• Proportion of subjects with hemoglobin increases of >1.0 g/dL in any 2-week interval during the Titration and Evaluation periods. [ Time Frame: Weeks 1 through 4, 5 through 8, 9 through 12, 13 through 16, 17 through 20, and 21 through 24. ] [ Designated as safety issue: Yes ]
  
• Proportion of subjects with hemoglobin increases of >2.0 g/dL in any 4-week interval during the Titration and Evaluation periods. [ Time Frame: Weeks 1 through 4, 5 through 8, 9 through 12, 13 through 16, 17 through 20, and 21 through 24. ] [ Designated as safety issue: Yes ]
  
• Incidence of Hematide-specific antibody formation. [ Time Frame: Weeks: 0, 1, 5, 9, 13, 17, 21 and 25. ] [ Designated as safety issue: Yes ]
  

According to the International Federation of Renal Registries, in 1999 the prevalence of peritoneal dialysis in the United States as approximately 9.5% of patients receiving dialysis (2005 United States Renal Data Systems data indicates a prevalence of around 7.5%). Data from Europe in 1999 to 2000 (not including the United Kingdom, France or Germany) indicated peritoneal dialysis was the mode of dialysis in approximately 11.1% of dialysis patients. 2006 data from the United Kingdom indicates that more than 20% of patients on dialysis are receiving peritoneal dialysis while French and German data indicate rates of 8.1% and 4.8% respectively. More than 90% of patients with chronic kidney disease Stage 5 (End Stage Renal Disease) are anemic. The vast majority of patients receiving hemodialysis or peritoneal dialysis receive erythropoiesis-stimulating agent therapy to treat their anemia.

There are several common clinical situations in which anemia appears to be the result of hypoproliferation of red blood cell precursors associated with an absolute or relative deficiency of erythropoietin. These include the anemias associated with chronic kidney disease or chronic renal failure, inflammation (anemia of chronic disease, such as rheumatoid arthritis) and the anemia associated with cancer with or without myelosuppressive chemo- and radiation therapies. In these situations, recombinant human erythropoietin has been used successfully to increase hemoglobin levels, reduce fatigue, improve daily function, and alleviate a wide range of symptoms, including decreased cognition, palpitations, dyspnea, dizziness and depression.

Anemia of chronic renal failure is due to several factors, primarily the inability of the diseased kidneys to produce adequate amounts of endogenous erythropoietin. Ancillary factors also include the shortened lifespan of red blood cells, iron and other nutritional deficiencies, infection, and inflammation. The prevalence of anemia increases with progressive deterioration of renal function, and affects more than 90% of patients with CKD Stage 5 (End Stage Renal Disease). Anemia is associated with increased mortality, increased likelihood of hospitalization, reduced cognitive function and exercise capacity, increased left ventricular hypertrophy and heart failure. Treatment of anemia reduces morbidity and mortality risks and may improve quality of life. Therefore, anemia should be diagnosed and treated early.

Erythropoiesis stimulating agents have been established as a treatment for anemia in chronic renal failure subjects, and have improved the management of anemia over alternatives such as transfusion. Hematide is a parenteral formulation being developed for the correction of anemia in patients with chronic renal failure, and binds to and activates the human erythropoietin receptor and stimulates erythropoiesis in human red cell precursors in a manner similar to other known erythropoiesis-stimulating agents.

Subjects participating in this study will receive variable doses of Hematide injection once every four weeks. Total commitment time for this study is about 29 weeks.

Inclusion Criteria:

• A female subject of childbearing potential who are sexually active agree to routinely use acceptable contraception from Screening throughout the duration of the study.
• The subject has chronic renal failure and has been on peritoneal dialysis for ≥3 months prior to enrollment.
• The subject is on stable subcutaneous epoetin (alfa or beta) maintenance therapy continuously prescribed for a minimum of 8 weeks prior to enrollment.
• The subject has 4 consecutive Hemoglobin values with a mean ≥10.0 and ≤12.0 g/dL during the Screening Period, with the difference between the mean of the first 2 consecutive Hemoglobin values and the mean of the last 2 consecutive Hemoglobin values being ≤1.0 g/dL.
• The subject has 1 ferritin level ≥100 ng/mL within 4 weeks prior to enrollment.
• The subject has 1 serum or red cell folate level ≥ lower limit of normal within 4 weeks prior to enrollment.
• The subject has 1 vitamin B12 level ≥ lower limit of normal within 4 weeks prior to enrollment.
• The subject has a negative test result for hepatitis B surface antigen, and hepatitis C virus antibody at Screening and no known history of human immunodeficiency virus infection.

Exclusion Criteria:

• If female, the subject is pregnant or lactating or intending to become pregnant before, during, or within 1 month after end of dosing this study; or intending to donate ova during such time period.
• The subject has known intolerance to any erythropoiesis-stimulating agent, all parenteral iron supplementation products, or any PEGylated molecules.
• The subject has known bleeding or coagulation disorder.
• The subject has known hematologic disease or cause of anemia other than renal disease (eg, pure red cell aplasia, homozygous sickle-cell disease, thalassemia, multiple myeloma, hemolytic anemia and myelodysplastic syndrome).
• The subject has had red blood cell or whole blood transfusion within 12 weeks prior to enrollment.
• The subject has received a recent course of intensive iron replacement (ie, has received more than 500mg IV in the 28 days prior to enrollment).
• The subject has poorly controlled hypertension within 4 weeks prior to enrollment, per investigator's clinical judgment.
• The subject has advanced chronic congestive heart failure - New York Heart Association Class III or IV.
• The subject has uncontrolled, or symptomatic inflammatory disease (eg, rheumatoid arthritis, systemic lupus erythematosus, etc).
• The subject has a known history of seizure disorder or received anti-epileptic medication for seizure disorder within 6 months prior to enrollment.
• The subject has a history of peritonitis within the 2 months prior to enrollment.
• The subject has any clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent.
• The subject has evidence of active malignancy within past 5 years (except non-melanoma skin cancer or carcinoma-in-situ that has been completely excised).
• The subject has a scheduled kidney transplant (Note: subjects currently on a transplant wait list are not excluded unless there is an identified donor).
• The subject is anticipated to change dialysis modality during the course of the study.
• The subject has a scheduled surgery that may be expected to lead to significant blood loss.
• The subject has previous exposure to any investigational agent within 4 weeks prior to enrollment, or planned receipt of an investigational agent, other than as specified by this protocol, during the study period.
• The subject has previous exposure to Hematide Injection.
• The subject has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 2 years prior to enrollment.