Study to Assess the Safety and Impact on Humoral Sensitization of SANGUINATE in Patients With End Stage Renal Disease

Inclusion Criteria:

1. Patient diagnosed with End State Renal Disease requiring renal replacement therapy.
2. Age 18 - 65 years of age who are on maintenance hemodialysis for at least 3 months prior to the study start;
3. Stable dialysis treatment regimen 3 times per week for ≥ 2 months prior to screening visit;
4. Hemoglobin >7.5 g/dL with or without clinical symptoms;
5. Women of childbearing potential must have a negative serum pregnancy test and must use a reliable method of contraception during the study period;
6. Signed and dated informed written consent by the subject or his/her legally authorized representative;

Exclusion Criteria:

1. In the judgment of the investigator the patient is not a good candidate for the study;
2. Blood transfusion with in the last 90 days from date of Screening;
3. Symptoms or electrocardiogram (ECG)-based signs of acute myocardial infarction, Unstable angina pectoris, decompensated heart failure, third degree heart block or cardiac arrhythmia associated with hemodynamic instability;
4. Total bilirubin greater than 1.5 mg/dL or transaminase (ALT, AST) elevations greater than 2 times the upper limit of the laboratory reference range or evidence of significant hepatic insufficiency;
5. Concurrent or prior treatment within 90 days of Screening with an investigational medication;
6. Chronic treatment (as determined by the Investigator) with any immunosuppressive medication (including corticosteroids) within the past 90 days of Screening;
7. Evidence or history of regular alcohol abuse;
8. Screening laboratory result(s) determined to be clinically significant by the investigator;
9. Screening laboratory result indicating HIV-positivity, or previously diagnosed with AIDS, AIDS related complex or any other immunodeficiency;
10. Screening laboratory result or laboratory results performed within one year indicating positivity for hepatitis B surface antigens, hepatitis B core antibodies, or hepatitis C antibodies;
11. Uncontrolled Diabetes Mellitus (Patients with HbA1c > 9% at screening)