Study to Evaluate the Safety, Efficacy and Pharmacokinetics of GSK1278863 in Japanese Hemodialysis-Dependent Subjects With Anemia Associated With Chronic Kidney Disease

Inclusion Criteria

• Age (Informed concent): Japanese >=20 years of age
• Gender (Screening 2 verification only): Female and male
• Females: must be of childbearing potential, and must agree to use one of the approved contraception methods from Screening 2 until completion of the Follow-up Visit. OR Of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrea [in questionable cases a blood sample with simultaneous follicle stimulating hormone 23.0 - 116.3 million international units (MIU)/millilitre (mL) and estradiol =360 IU/kilograms (kg)/week IV or darbepoetin dose of >=1.8 micrograms (μg)/kg/week IV within the prior 8 weeks through Screening 2.
• methoxy polyethylene glycol epoetin beta (Screening 2 verification only): Use of methoxy polyethylene glycol epoetin beta within the prior 8 weeks through Screening 2.
• Vitamin B12: At or below the lower limit of the reference range
• Folate: 100 mmHg or systolic blood pressure >170 mmHg.
• Thrombotic disease: History of thrombotic disease (e.g., venous thrombosis such as deep vein thrombosis or pulmonary embolism, or arterial thrombosis such as new onset or worsening limb ischemia requiring intervention), except vascular access thrombosis, within the 8 weeks prior to Screening 2 through Day 1
• Eyes: History of proliferative retinopathy requiring treatment within the prior 12 months or macular edema requiring treatment..
• Inflammatory disease: Active chronic inflammatory disease that could impact erythropoiesis (e.g., scleroderma, systemic lupus erythematosis, rheumatoid arthritis, celiac disease) diagnosed prior to Screening 2 through Day 1.
• Hematological disease: Any hematological disease including those affecting platelets, white or red blood cells (e.g. sickle cell anemia, myelodysplastic syndromes, hematological malignancy, myeloma, hemolytic anemia and thalassemia), coagulation disorders (e.g., antiphospholipid syndrome, Protein C or S deficiency), or any other cause of anemia other than renal disease diagnosed prior to Screening 2 through Day 1.
• Liver disease: Current liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) or evidence at Screening of abnormal liver function tests [alanine transaminase (ALT) or aspartate transaminase (AST) >2.0 x upper limit of normal (ULN) or total bilirubin > 1.5 x ULN]; or other hepatic abnormalities that in the opinion of the investigator (subinvestigator) would preclude the subject from participation in the study.
• Major surgery: Major surgery (excluding vascular access surgery) within the prior 8 weeks, within the Screening 2 to Day 1 or planned during the study.
• Transfusion: Blood transfusion within the prior 8 weeks, within the Screening 2 to Day 1 or an anticipated need for blood transfusion during the study.
• Gastrointestinal (GI) bleeding: Evidence of actively bleeding peptic, duodenal, or esophageal ulcer disease OR clinically significant GI bleeding within the 8 weeks prior to Screening 2 through Day 1.
• Acute infection: Clinical evidence of acute infection or history of infection requiring IV antibiotic therapy within 8 weeks prior to Screening 2 through Day 1.
• Malignancy: Subjects with a history of malignancy within the prior 5 years, who receiving treatment for cancer, or who have a strong family history of cancer (e.g., familial cancer disorders); with the exception of squamous cell or basal cell carcinoma of the skin that has been definitively treated prior to Screening 2 through Day 1.
• Severe allergic reactions: History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product
• Drugs and supplements: Use of any prescription or non-prescription drugs or dietary supplements that are prohibited from Screening 2 until the Follow-up Visit.
• Prior investigational product expos