Assess the Safety and Efficacy of Nephoxil® in Subjects With End Stage Renal Disease (ESRD) on Dialysis

This study is an open-label, prospective, long term, Phase IV study to assess the safety and efficacy of Nephoxil® in subjects with ESRD on dialysis.

Inclusion criteria

• Is ≧ 18 years of age on the day of signing informed consent or other age required by local regulation
• Willing and able to provide written informed consent
• ESRD patients who is undergoing hemodialysis 3 times per week and is considered necessary to receive medication for hyperphosphatemia by his/her treating physician
• Serum ferritin <1000 ng/mL and transferrin saturation (TSAT) < 50% at the Enrollment Visit
• Women of child-bearing potential (WOCBP [defined as women ≤ 50 years of age with a history of amenorrhea for < 12 months prior to study entry]) who is willing to use an effective form of contraception during study participation

Exclusion criteria

• Has any known contraindication to ferric citrate according to locally approved prescribing information, include but not limited to the following criteria:

i. Is allergic to ferric citrate ii. Has hypophosphatemia iii. Has hemochromatosis or iron overload syndromes iv. Has active severe GI disorders

• Has parathyroidectomy (PTx) or percutaneous ethanol injection therapy (PEIT) within 3 months prior to Enrollment Visit or serum calcium < 7 mg/dL at the Enrollment Visit
• Has participated in another interventional study for any investigational agent or device within 30 days prior to enrollment
• Is currently pregnant or breastfeeding
• Other unstable medical condition or psychiatric conditions that is considered unsuitable for this study per Investigator's clinical judgment