Safety Study of Soluble Ferric Pyrophosphate (SFP) in Dialysate in CKD Patients Receiving Chronic Hemodialysis

Exclusion Criteria

• •1. Any previous exposure to SFP.
• •2. Therapy with intravenous, intramuscular or oral iron at any time between the first/screening visit and the randomization visit, or anticipated requirement for iron supplementation during the study period.
• •3. Non-tunneled vascular catheter for dialysis.
• •4. Scheduled for kidney transplant within the next 8 weeks.
• •5. Active infection requiring systemic antimicrobial or antifungal therapy within 2 weeks prior to screening, or during screening period prior to randomization.
• •6. Hospitalization within 1 month prior to screening (except for vascular access surgery).
• •Extension Study, Open Label, Single Active Arm:
• •1. Had a serious adverse event attributable (i.e., probably, possibly, or definitely related) to study drug or had an adverse event attributable to study drug that necessitated premature withdrawal from the double-blind, placebo-controlled crossover phase of the parent study RMTI-SFP-6.
• •2. Non-tunneled vascular catheter for dialysis.
• •3. Scheduled for kidney transplant within 12 weeks after entry into extension phase.
• •4. Active infection requiring systemic antimicrobial or antifungal therapy within 2 weeks prior to dosing.
• •5. Pregnancy or intention to become pregnant during the study.