Ferric Citrate for the Prevention of Renal Failure in Adults With Advanced Chronic Kidney Disease

Exclusion Criteria

• •1. Patients who, in the opinion of the Investigator, have acute kidney injury rather than CKD.
• •2. Patients with planned/imminent maintenance dialysis, or that are anticipated to begin maintenance dialysis within 8 weeks from Screening, in the opinion of the Investigator.
• •3. A known allergy or intolerance to ferric citrate or any of its constituents.
• •4. Hypersensitivity reaction to previous oral iron therapy.
• •5. History of hemochromatosis or iron overload syndrome (e.g., hereditary sideroblastic anemia, thalassemia, polycythemia vera).
• •6. Active malignancy requiring current treatment except for non-melanoma skin cancer regardless of treatment.
• •7. Active drug or alcohol dependence or abuse (excluding tobacco use or use of medical or recreational marijuana) within the 12 months prior to Screening or evidence of such abuse, in the opinion of the Investigator.
• •8. Limited life expectancy (less than 6 months) in the opinion of the Investigator.
• •9. Females who are known to be pregnant or are breast-feeding during Screening or are planning to become pregnant and breastfeeding during the study period.
• •10. Evidence of a clinically active infection requiring antibiotics at Randomization.
• •11. Unable to comply with study requirements or in the opinion of the Investigator, not clinically stable to participate in the study.
• •12. Use of an investigational medication or participation in an investigational study within 30 days prior to Day 1.
• •13. Patients with a scheduled date for receipt of living donor kidney transplant