Ferric Citrate and Chronic Kidney Disease in Children

Eligibility Criteria

• 1. Ages 6 to 18 years (inclusive);
• 2. Estimated Glomerular Filtration Rate (GFR) of 15-59 ml/min per 1.73 m2 by modified Chronic Kidney disease in Children (CKiD) formula;56
• 3. Serum phosphate within age appropriate normal levels;
• 4. Serum ferritin \<500 ng/ml and TSAT \<50%;
• 5. For those patients treated with growth hormone, calcitriol, nutritional vitamin D, iron, and/or erythropoiesis-stimulating agents (ESAs) such treatments must have stable dosing for at least 2 weeks prior to screening;
• 6. Able to swallow tablets;
• 7. Able to eat at least two meals a day;
• 8. In the opinion of the investigator, willing and able to follow the study treatment regimen and comply with the site investigator's recommendations.
• 1. Patients currently treated with phosphate binders.
• 2. History of allergy to all ingredients (including non-medical ingredients) in both products (i.e. investigational product and placebo)
• 3. Current intestinal malabsorption, documented in the medical record; significant GI disorders including GI bleeding or active inflammatory bowel disease, inflammatory bowel syndrome, and/or Crohn's Disease
• 4. Anticipated initiation of dialysis or kidney transplantation within 6 months
• 5. Current or planned future systemic immunosuppressive therapy
• 6. Prior solid organ transplantation
• 7. Receipt of bone marrow transplant within two years of screening
• 8. Current pregnancy, lactation or female subjects who have reached menarche, unless using highly-effective contraception as outlined in section 7.1.1 of Protocol
• 9. Patients participating in other interventional study (observational study participation permitted)
• 10. Poor adherence to medical treatments in the opinion of the investigator
• 11. Hemochromatosis or laboratory tests indicating possible hemochromatosis or other iron overload (primary or secondary) syndrome
• 12. Cystinosis
• 13. Fanconi syndrome