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

Inclusion Criteria:

- Eligible male or female subjects were previously enrolled in Study 16208, have a
diagnosis of anemia associated with CKD, and are on hemodialysis.

- Men who agree to use adequate contraception when sexually active or women without
childbearing potential

- Participation and completion of treatment in Study 16208; subjects must have received
16 weeks of study medication and completed the end of treatment visit (Day 113) in
the parent study

- Mean Hb concentration of 9.5 to 11.5 g/dL, inclusive, during the evaluation period
(i.e., the last 4 weeks of the parent study) when the subject completed 16 weeks of
treatment with BAY85-3934, epoetin alfa, or epoetin beta in Study 16208

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)

- Updates to medical and surgical history which meet the exclusion criteria in the
parent study

- 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