Hemoglobin Maintenance in Pediatric ESRD (End-stage Renal Disease) Patients by Ferric Pyrophosphate Citrate (FPC)

Inclusion Criteria

• •A patient will be eligible for inclusion in the study only if all of the following criteria are met:
• •1. Parents/legal guardians of the patient have the ability to understand the requirements of the study and have demonstrated a willingness to have their child comply with all study procedures by signing an institutional review board-approved informed consent form. Where applicable, assent of the patient has also been obtained for all study procedures prior to any study-related activities.
• •2. Patient is between 6 months and \<18 years of age at screening.
• •3. Patient has chronic kidney disease receiving in-center hemodialysis at least twice weekly for at least 3 months prior to screening.
• •4. Patient is receiving adequate hemodialysis as assessed by the investigator and based on a single pool Kt/V measurement \>1.2.
• •5. Patient has a vascular access (tunneled catheter, AV fistula or AV graft) suitable to support blood flows for hemodialysis treatment.
• •6. Patient has a body mass of ≥11 lbs (5 kg).
• •7. Patient is iron-replete as measured by a TSAT ≥ 20% and a ferritin \>100 µg/L at screening.
• •8. Patient has a whole blood Hgb concentration of ≥ 9.5 g/dL at screening.
• •9. If the patient is female, she must be pre-pubertal, have had documented surgical sterilization prior to Baseline admission, or be practicing adequate birth control. All female patients who have reached menarche must have a negative serum pregnancy test during screening. It is the investigator's responsibility to determine whether the patient has adequate birth control for study participation.
• •10. Patients who have experienced a previous adverse event with IV iron products are eligible to participate in this study if the agent that caused the event is not administered during the Baseline period.