Study to Evaluate the Safety and Tolerability of Ferric Citrate in Children With Hyperphosphatemia Related to Chronic Kidney Disease

Exclusion Criteria

• •Active significant GI disorder, including overt GI bleeding or active inflammatory bowel disease.
• •Liver transaminases (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\]) \>3× the upper limit of normal at Screening.
• •Unable to swallow pills, if participant requires tube feeding, ferric citrate must be taken orally and not administered via feeding tube.
• •Non-renal cause of hyperphosphatemia.
• •Active drug or alcohol dependence or abuse (excluding tobacco use or medicinal marijuana) within the 12 months prior to Screening or evidence of such abuse (in the opinion of the Investigator).
• •Malignancy, except for participants who have been disease-free for at least 2 years after curative therapy.
• •Participants with a functioning organ transplant.
• •A known allergy or intolerance to ferric citrate or any of its constituents.
• •Female participants who do not agree to remain abstinent or assent to use a combination of 2 of the following highly effective birth control methods for at least 28 days before the first dose, during the study (including during dose interruptions), and for at least 30 days after the last dose:
• •* Barrier method of contraception: condoms (female or male) with or without a spermicidal agent, diaphragm, or cervical cap with spermicide.
• •* Intrauterine device (IUD).
• •* Hormone-based contraceptives which are associated with inhibition of ovulation.
• •Females who are pregnant or breast-feeding other children. Participants who are being breastfed are eligible to participate in this study.
• •Any other medical condition that, in the opinion of the Investigator, renders the participant unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the participant.
• •The participant, in the opinion of the Investigator, is unable to adhere to the requirements of the study.
• •Receipt of any investigational drug within 4 weeks before Screening.
• •History of hemochromatosis or iron overload syndrome (e.g, hereditary sideroblastic anemia, thalassemia).