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

The purpose of the study is to investigate the safety of SANGUINATE on humoral sensitization
in End Stage Renal Disease (ESRD) patients receiving dialysis.

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)