Dose Ranging Study of Dialysate Containing Soluble Iron to Treat Subjects With End Stage Renal Disease (ESRD) Receiving Chronic Hemodialysis

1. Hemoglobin (Hgb) values on two successive baseline/screening measurements that average ≥ 11.6g/dL

2. Subject with a current malignancy involving a site other than skin

3. Subject with a history of drug or alcohol abuse within the last six months

4. Subject believed to be unable to complete the entire study (e.g., due to a concurrent disease, life expectancy of less than a year)

5. Subject who the Principal Investigator considers will be placed at increased risk by the study procedures

6. Subject requiring hemodialysis more than 3 times per week on a regular basis.

7. Subject who is unable to discontinue oral iron or intravenous iron supplements for the duration of the study

8. Subject who is pregnant

9. Subject considered incompetent to give an informed consent

10. Subject with a positive test for Hepatitis B Surface Antigen within the past 30 days or during screening

11. Subject with known HIV infection (if this is not known, no HIV testing will be performed)

12. Subject with cirrhosis of the liver based on histological criteria or clinical criteria (presence of ascites, esophageal varices, spider nevi, or history of hepatic encephalopathy). Subject with hepatitis C, in the absence of cirrhosis, is not excluded from participation in the study if ALT and AST levels are below 2 times the upper limit of normal consistently during the 2 months preceding enrollment

13. Subject with active tuberculosis, fungal, viral, or parasitic infection

14. Subject with active bacterial infection requiring antibiotic therapy

15. Subject with pre-dialysis Corrected Q-wave to T-wave (QTc) interval ≥ 470 milliseconds (ms)

16. Subject with a history of hypokalemia, decompensated heart failure, or family history of Long QT Syndrome that in the Investigator's judgment poses a risk for Torsades de Pointe during the study

17. Subject using concomitant medications known to prolong QT/QTc interval (See Appendix I, TABLE A)

18. Subject receiving more than 60,000 units or 120 micrograms of erythropoietin (Epogen®, Procrit®, or Aranesp®) per week

19. Subject has participated in another clinical trial within 30 days of signing Informed Consent

What this study is about