Efficacy and Safety Study of GSK1278863 in Japanese Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease Who Are Not Taking Erythropoiesis Stimulating Agents

Inclusion Criteria

• Age (at the time of informed consent): >=20 years
• Dialysis: Patients on hemodialysis (HD) or hemodiafiltration (HDF)
• Use of any erythropoiesis stimulating agent (ESA): Newly started dialysis (Dialysis newly started =12 weeks before screening): Patients not using ESAs within 8 weeks before screening (including interruption of ESA therapy)
• Hemoglobin (Hgb): >=8.0 to 100 nanograms (ng)/milliliter (mL) or transferrin saturation (TSAT) >20% (at screening only)
• Gender (at screening only): Female or male.

A female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotropin [hCG] test for females of reproductive potential [FRP] only), not breastfeeding, and at least one of the following conditions applies:

• Females of non-reproductive potential defined as: Pre-menopausal with one of the following and no plans to utilise assisted reproductive techniques (example [e.g.], in vitro fertilisation or donor embryo transfer): documented bilateral tubal ligation or salpingectomy; documented hysteroscopic tube occlusion procedure with follow-up confirmation of bilateral tubal occlusion; hysterectomy; documented bilateral oophorectomy
• Post-menopausal defined as females 60 years of age or older or In females 500 milliseconds (msec), or QTc >530 msec in subject with bundle branch block. Note: Corrected QT interval using Bazett's formula (QTcB) (machine-read or manually) will be used.

Other disease-related criteria

• Liver disease (if any of the following occurs):
• Alanine transaminase (ALT) >2x upper limit of normal (ULN)
• Bilirubin >1.5xULN (If bilirubin fractions are measured and direct bilirubin is 1.5xULN will be acceptable.)
• Current unstable active liver or biliary disease (generally defined by the onset of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, persistent jaundice, or cirrhosis). Note: The only exception is squamous cell or basal cell carcinoma of the skin that has been definitively treated >=8 weeks before screening.
• Malignancy: History of malignancy within the two years prior to screening, known complex kidney cyst >3 centimeters (cm) (II F, III or IV based on the Bosniak classification) or currently receiving treatment for cancer. Note: The only exception is squamous cell or basal cell carcinoma of the skin that has been definitively treated >=8 weeks before screening.

Concomitant medications and other study treatment-related criteria

• Iron medication: Planned use of any intravenous iron during the screening period or from Day 1 to Week 4.

Note:

• Patients on oral iron may be enrolled if the iron dose regimen is unchanged during the screening period and from Day 1 to Week 4.
• Patients on anti-hyperphosphatemia medication containing iron (e.g., ferric citrate hydrate) for at least 12 weeks before screening may be enrolled if the medication is continued during the screening and from Day 1 to Week 4.
• Severe allergic reactions: History of severe allergic or anaphylactic reactions or hypersensitivity to any excipients in the investigational product
• Drugs and dietary supplements: Current use of prohibited prescription drugs, non-prescription drugs, or dietary supplements or planned use of any of these drugs during the study period (prohibited drugs: strong cytochrome P450 (CYP)2C8 inducers and inhibitors)
• Exposure to any other investigational product: Use of an investigational product within the past 30 days or five half lives of that investigational product (whichever is longer).
• Prior treatment with GSK1278863: Prior treatment with GSK1278863 for >30 days General health-related criteria
• Other conditions: Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance or prevent understanding of the aims or investigational procedures or possible consequen