Study of FG-4592 to Correct Anemia in New Dialysis Patients

Inclusion Criteria:

1. Age 18 to 80 years

2. Receiving hemodialysis or peritoneal dialysis for end- stage renal disease (ESRD) for
2 weeks to 4 months.

3. Hemoglobin < 10 g/dL

4. Body weight 40 to 140 kg

Exclusion Criteria:

1. Previously received erythropoiesis-stimulating agents

2. Received IV iron within 4 weeks prior to randomization

3. Received red blood cell transfusion within 8 weeks prior to randomization

4. Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B
surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab)

5. History of chronic liver disease

6. Clinically significant infection

7. New York Heart Association Class III or IV congestive heart failure

8. History of cancer within the past 4 years

9. Chronic inflammatory disease even if it is in remission

10. History of other blood disorders

11. Active hemolysis or diagnosis of hemolytic syndrome

12. Known bone marrow fibrosis

13. Uncontrolled or symptomatic secondary hyperparathyroidism

14. History of alcohol or drug abuse

15. History of allergy or sensitivity to oral or intravenous iron

16. Heart attack, deep vein thrombosis, or pulmonary embolism in the past 3 months

17. Seizure disorder or receiving anti-epilepsy medication

18. Pregnant or breast-feeding females