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

Inclusion Criteria:

1. Adult patients greater or equal to 18 years old.

2. Diagnosis of NDD advanced CKD, regardless of etiology. Advanced CKD is defined as atleast one local laboratory determined estimated glomerular filtration rate (eGFR) ≤20 ml/min/1.73m2 (calculated per any commonly used method or equation forestimating eGFR) within 90 days of Day 1.

3. Most recent transferrin saturation (TSAT) less than or equal to 45% within 45 daysof Day 1.

4. Most recent serum phosphate is greater or equal to 3.0 mg per dL within 45 days ofDay 1.

5. Most recent ferritin is less than or equal to 500 ng per mL within 45 days of Day 1.

6. Women of child-bearing potential must have a negative serum or urine pregnancy testwithin 28 days prior to Day 1.

7. Understands the procedures and requirements of the study and provides writteninformed consent and authorization for protected health information disclosure.

Exclusion Criteria:

1. Patients who, in the opinion of the Investigator, have acute kidney injury ratherthan CKD.

2. Patients with planned/imminent maintenance dialysis, or that are anticipated tobegin maintenance dialysis within 8 weeks from Screening, in the opinion of theInvestigator.

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 sideroblasticanemia, thalassemia, polycythemia vera).

6. Active malignancy requiring current treatment except for non-melanoma skin cancerregardless of treatment.

7. Active drug or alcohol dependence or abuse (excluding tobacco use or use of medicalor recreational marijuana) within the 12 months prior to Screening or evidence ofsuch 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 areplanning 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, notclinically stable to participate in the study.

12. Use of an investigational medication or participation in an investigational studywithin 30 days prior to Day 1.

13. Patients with a scheduled date for receipt of living donor kidney transplant