Study to Evaluate the Safety and Efficacy of GSK1278863 in Recombinant Human Erythropoietin (rhEPO) Hyporesponsive Hemodialysis-dependent Chronic Kidney Disease Subjects With Anemia

Inclusion Criteria:

- Hemodialysis (HD) frequency: Stable HD regimen of three to four times weekly for a
minimum of 12 weeks. Note: The type and frequency of dialysis must be stable during
the study. Isolated ultrafiltration sessions for the purposes of fluid removal are
permitted.

- Dialysis Adequacy: Single-pool dialyzer clearance multiplied by dialyzer time divided
by volume of distribution of urea (Kt/Vurea) of >=1.2 based on a historical value
obtained within the prior month.

- rhEPO hyporesponsiveness: Historical and current intravenous (IV) rhEPO and Hgb
values. Average epoetin alfa dose and Hgb level for three 4-week periods for a total
of 12 weeks prior to Week -4, and during the 4 week run-in period, must be within the
following ranges: average epoetin alfa dose >4000 and <=6000 units per session and
Hgb >=8.0 and <=9.5 g/dL; average epoetin alfa dose >6000 and <=8000 units per
session and Hgb >=8.0 and <=10.0 g/dL; average epoetin alfa dose >8000 and <=10000
units per session and Hgb >=8.0 and <=10.5 g/dL; and average epoetin alfa dose >10000
units per session and Hgb >=8.0 and <=11.0 g/dL.

- Absolute difference between the Hgb value at Week -4 and Week 0 (Day 1), must be <1.3
g/dL. Note: Subjects who do not meet the criteria after being rescreened twice,
should not be entered into the GSK1278863 treatment period and should be withdrawn
from the study.

- Age: >=18 years of age.

- Q-T Interval Corrected for Heart Rate (QTc): Bazett's Correction of QT Interval
(QTcB) <470 msec or QTcB <480 milliseconds (msec) in subjects with bundle branch
block. There is no corrected QT interval (QTc) inclusion criterion for a subject with
a predominantly paced rhythm.

- Gender: Female and male subjects. Females: If of childbearing potential, must agree
to use one of the approved contraception methods from Screening until completion of
the Follow-up Visit OR, of non-childbearing potential defined as pre-menopausal
females with a documented tubal ligation, hysterectomy or oophorectomy; or
postmenopausal defined as 12 months of spontaneous amenorrea [in questionable cases a
blood sample with simultaneous follicle stimulating hormone (FSH) 23.0-116.3
milliinternational units (MIU)/milliliter (mL) (23.0-116.3 international units
(IU)/liter (L)) and estradiol <=10 picograms (pg)/mL (<=37 picomole (pmol)/L) is
confirmatory]. Females on hormone replacement therapy (HRT) whose menopausal status
is in doubt will be required to use one of the approved contraception methods if they
wish to continue their HRT during the study. Otherwise they must discontinue HRT to
allow confirmation of post-menopausal status prior to study enrollment. For most
forms of HRT, at least 2 weeks will elapse between the cessation of therapy and the
blood draw; this interval depends on the type and dosage of HRT. Following
confirmation of their post-menopausal status, they can resume use of HRT during the
study without use of a contraceptive method.

Exclusion Criteria:

- Dialysis modality: Planned change in dialysis modality within the study time period.

- rhEPO: Use of methoxy polyethylene glycol epoetin beta or darbepoetin within the
prior 8 weeks prior to Week -4.

- Renal transplant: Scheduled renal transplant.

- Transferrin saturation (TSAT): <20% on the most recent sample taken over the last 12
weeks.

- Ferritin: <100 nanograms (ng)/mL (<100 micrograms/L) on the most recent sample taken
over the last 12 weeks.

- Vitamin B12: At or below the lower limit of the reference range (may rescreen in a
minimum of 8 weeks).

- Folate: <2.0 ng/mL (<4.5 nanomoles (nmol)/L) (may rescreen in a minimum of 4 weeks).

- Myocardial infarction or acute coronary syndrome: Within the 8 weeks prior to Week
-4.

- Stroke or transient ischemic attacks (TIAs): Within the 8 weeks prior to Week -4.

- Heart failure: Class III/IV heart failure, as defined by the New York Heart
Association (NYHA) functional classification system diagnosed prior to Week -4.

- Hypertension: Defined using pre-dialysis vitals (Week -4) of diastolic blood pressure
>100 millimeters of mercury (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) within the 8 weeks prior to Week
-4, except vascular access thrombosis.

- Inflammatory disease: Active chronic inflammatory disease that could impact
erythropoiesis (e.g., scleroderma, systemic lupus erythematosis, rheumatoid
arthritis, celiac disease) diagnosed prior to Week -4.

- Hematological disease: Any hematological disease including those affecting platelets,
white or red blood cells (e.g., antibody-mediated pure red cell aplasia, sickle cell
anemia, myelodysplastic syndromes, hematological malignancy, myeloma, hemolytic
anemia), coagulation disorders (e.g., antiphospholipid syndrome, Protein C or S
deficiency), or any other cause of anemia other than renal disease diagnosed prior to
Week -4.

- 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 would
preclude the subject from participation in the study. NOTE: Those with Hepatitis B or
Hepatitis C are eligible provided these exclusions are not met.

- Major surgery: (excluding vascular access surgery) within the 8 weeks prior to Week
-4, or planned during the study.

- Transfusion: Blood transfusion within the 8 weeks prior to Week -4, 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 Week -4.

- Ophthalmology disease: History of proliferative retinopathy requiring treatment
within the prior 12 months or macular edema requiring treatment.

- Acute infection: Clinical evidence of acute infection, evidence of underlying
infection or history of infection requiring IV antibiotic therapy within the 8 weeks
prior to Week -4, and also through to Day 1. Note: IV antibiotics as prophylaxis are
allowed.

- Malignancy: Subjects with a history of malignancy within the prior 5 years, who are
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 Week -4.

- 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 Week -4 until the Follow-up Visit.

- Prior investigational product exposure: The subject has participated in a clinical
trial and has received an experimental investigational product within the prior 30
days to Week -4.

- Life Expectancy: Life expectancy is considered by the investigator to be less than 6
months.

- Other conditions: Any other conditions, clinical or laboratory abnormality, or
examination finding that the Investigator considers would put the subject at
unacceptable risk, or an unwillingness or inability to follow the procedures, or
lifestyle and/or dietary restrictions outlined in the protocol.

- Pregnancy and lactation: Pregnant females as determined by positive serum human
chorionic gonadotrophin (hCG) test or women who are lactating at Week -4 or during
the trial.

- Laboratory eligibility criteria will be assessed according to the central laboratory
result for the screening samples

- Subjects who fail screening may be rescreened as soon as the investigator feels they
may have subsequently become eligible. However, an individual subject may not be
rescreened more than twice. There is no predetermined amount of time required to wait
to rescreen a previously ineligible subject. Exceptions are those failing on Hgb or
folate who may rescreen in 4 weeks and those failing for Vitamin B12 where
rescreening may occur in 8 weeks.