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

Exclusion Criteria

• •A scheduled kidney transplant or any other organ transplant within the next 6 months (being on a waiting list does not exclude the subject)
• •Subjects treated with immunosuppressive therapy and the breast cancer resistant protein (BCRP) substrates, irinotecan, topotecan, methotrexate, imatinib, and lapatinib
• •Sustained, poorly controlled arterial hypertension or hypotension at baseline, defined as mean BP ≥ 180/110 mmHg or systolic BP \< 95 mmHg, respectively
• •Severe rhythm or conduction disorder (e.g., HR \< 50 or \> 110 bpm, atrial fibrillation or flutter, prolonged QT \> 500 msec, second or third degree atrioventricular \[AV\] block)
• •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 x the upper limit of norma \[ULN\], total bilirubin \> 2 mg/dL, or Child-Pugh B or C) or active hepatitis in the investigator's opinion
• •An ongoing SAE from Study 16208 that is assessed as related to study drug
• •Alcohol or drug abuse