Quantitative Mass Transfer of SFP-iron From Dialysate to Blood in CKD-HD Patients

Exclusion Criteria

• •1. Subject has a living kidney donor identified or living-donor kidney transplant scheduled during study participation. (Note: Patients awaiting deceased-donor transplant need not be excluded.)
• •2. Vascular access for hemodialysis is a femoral catheter.
• •3. Known active bleeding from any site other than AV fistula or graft (e.g., gastrointestinal, hemorrhoidal, nasal, pulmonary, etc.).
• •4. Scheduled surgery during the study.
• •5. RBC or whole blood transfusion within 4 weeks prior to Screening.
• •6. Hospitalization in the month prior to Screening (except for vascular access surgery) that, in the opinion of the Investigator, confers a significant risk of hospitalization during the course of this study.
• •7. Evidence of current malignancy involving a site other than skin (except any melanoma, which renders the patient non-eligible).
• •8. History of drug or alcohol abuse within the last 6 months.
• •9. Regularly requiring hemodialysis more than three times per week.
• •10. Noncompliance with dialysis regimen in the opinion of the Investigator.
• •11. Pregnancy or intention to become pregnant before completing all study drug treatment.
• •12. Known ongoing inflammatory disorder (other than CKD), such as systemic lupus erythematosus, rheumatoid arthritis, or other collagen-vascular disease undergoing a disease flare.
• •13. Any current febrile illness (e.g., oral temperature \> 100.4°F, 38°C). (The patient may subsequently become eligible at least 1 week after resolution of the illness).
• •14. Known active bacterial, tuberculosis, fungal, viral, or parasitic infection requiring anti-microbial therapy or anticipated to require anti-microbial therapy during the patient's participation in this study.
• •15. Occult tuberculosis requiring prophylactic treatment with anti-tubercular drug(s) that overlaps with the patient's participation in this study.
• •16. Known positive status for hepatitis B surface antigen (hepatitis B testing is not required as part of this protocol).
• •17. Known human immunodeficiency virus (HIV) infection (HIV testing is not required as part of this protocol).
• •18. Cirrhosis of the liver based on histological criteria or clinical criteria (i.e., presence of ascites, esophageal varices, multiple spider nevi, or history of hepatic encephalopathy).
• •19. Active hepatitis with ALT and/or AST levels consistently greater than twice the upper limit of normal at any time during the two months prior to enrollment.
• •20. Participation in a study of an investigational drug or device within 30 days prior to randomization in this study.