Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934

Inclusion Criteria:

- - Eligible subjects will have a diagnosis of anemia associated with CKD(chronic
kidney disease).

- Women without childbearing potential

- Male or female subject ≥ 18 years of age with anemia of CKD at screening

- On dialysis, defined as regular long-term hemodialysis, with the same modality of
dialysis for ≥ 3 months before randomization

- Dialysis vascular access via native arteriovenous fistula, synthetic graft, long-term
catheters, or long-term tunneled catheters

- Treated with epoetin alfa (US or Japan) or epoetin beta (Japan) via intravenous (IV)
or subcutaneous (SC) route, on stable dosing defined as a < 50% change from the
maximum prescribed weekly dose with no change in the prescribed frequency during the
last 8 weeks prior to randomization

- At least one kidney

- Mean screening Hb concentration 9.0 to 11.5 g/dL inclusive (mean of all local
laboratory Hb measurements [at least 2 measurements must be taken ≥ 2 days apart]
during the 4 week screening period, AND none of the measurements can be < 9.0 g/dL or
> 12.0 g /dL

- Serum ferritin levels ≥ 100 μg/L OR transferrin saturation ≥ 20% at screening. Iron
substitution is allowed

- Folate and vitamin B12 levels above the lower limit of normal. Supplementation is
allowed

- Exclusion Criteria:

- Subjects with significant acute or chronic bleeding, such as overt gastrointestinal
bleeding

- Hereditary hemoglobinopathies (including, but not limited to, sickle cell disease,
beta thalassemia, and thalassemia major) which may be the primary cause of anemia

- Chronic lymphoproliferative diseases

- Any allograft (including renal allograft) in place and on immunosuppressive therapy,
or a scheduled kidney transplant within the next 16 weeks (being on a waiting list
does not exclude the subject)

- Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus
erythematosis, rheumatoid arthritis, celiac disease)

- Subjects treated with immuno- or myelosuppressive therapy within 8 weeks prior to
randomization: e.g., everolimus, sirolimus, rituximab, azathioprine, mycophenolate
mofetil, mycophenolic acid, cyclosporine,methotrexate, and tacrolimus,
chemotherapeutic agents and other anticancer agents, and systemic steroids (except
inhaled steroids) for 7 days

- RBC-containing transfusion within 8 weeks before randomization

- History of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial
infarction, stroke, transient ischemic attack, deep vein thrombosis, pulmonary
embolism) within the last 6 months from the initial screening visit

- Sustained, poorly controlled arterial hypertension or hypotension at screening,
defined as a mean BP ≥ 180/110 mmHg or systolic BP < 95 mmHg, respectively

- Severe rhythm or conduction disorder (e.g., HR < 50 or > 110 bpm, atrial flutter,
prolonged QT >500 msec, second or third degree atrioventricular [AV]block if not
treated with a pacemaker)

- New York Heart Association Class III or IV congestive heart failure

- Severe hepatic insufficiency (defined as alanine aminotransferase [ALT], aspartate
aminotransferase [AST], or gamma-glutamyl transferase > 3 times the upper limit of
normal [ULN], total bilirubin > 2 mg/dL, or Child-Pugh B or C) or active hepatitis in
the investigator's opinion

- A scheduled surgery that may be expected to lead to significant blood loss