| Outcome Measures: |
Primary: Incidence of Treatment-emergent Adverse Events, Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention., Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|Incidence of Treatment-emergent Adverse Events of Intradialytic Hypotension, Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. For each adverse event, investigators assessed whether the event met the protocol criteria for intradialytic hypotension. Intradialytic hypotension events were only to have been reported as adverse events if they exceeded the individual subject's baseline pattern of intradialytic hypotension., Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|Incidence of Related Suspected Hypersensitivity Reactions, Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. For each adverse event, investigators assessed whether the event met protocol criteria for suspected hypersensitivity reactions., Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study | Secondary: Incidence of Composite Cardiovascular Events, Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse event terms meeting criteria for composite cardiovascular events were pre-specified in the statistical analysis plan for the study., Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|Incidence of Hemodialysis Vascular Access Thrombotic Events, Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse event terms meeting criteria for hemodialysis vascular access thrombotic events were pre-specified in the statistical analysis plan for the study., Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|Incidence of Other Thrombotic Events, Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse event terms meeting criteria for other thrombotic events were pre-specified in the statistical analysis plan for the study., Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|Incidence of Systemic/Serious Infections, Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse events of systemic/serious infections were defined in the statistical analysis plan for the study to include infections for which the subject was administered at least 3 doses of an IV antibiotic, and infections for which the subject was hospitalized., Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|Incidence of Serious Adverse Events, Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. For each adverse event, investigators assessed whether the event met seriousness criteria., Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study | Other: Serum Iron Change From Pre-dialysis to Post-dialysis at Week 2, Serum iron was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 2. Because of the crossover nature of the study, the week 2 values reflect effects of SFP in the SFP/Placebo arm and effects of Placebo in the Placebo/SFP arm., Pre-dialysis and post-dialysis during study week 2 of the Parent (Crossover) Study|Serum Iron Change From Pre-dialysis to Post-dialysis at Week 5, Serum iron was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 5. Because of the crossover nature of the study, the week 5 values reflect effects of Placebo in the SFP/Placebo arm and effects of SFP in the Placebo/SFP arm., Pre-dialysis and post-dialysis during study week 5 of the Parent (Crossover) Study|Unsaturated Iron-binding Capacity Change From Pre-dialysis to Post-dialysis at Week 2, Unsaturated iron-binding capacity was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 2. Because of the crossover nature of the study, the week 2 values reflect effects of SFP in the SFP/Placebo arm and effects of Placebo in the Placebo/SFP arm., Pre-dialysis and post-dialysis during study week 2 of the Parent (Crossover) Study|Unsaturated Iron-binding Capacity Change From Pre-dialysis to Post-dialysis at Week 5, Unsaturated iron-binding capacity was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 5. Because of the crossover nature of the study, the week 5 values reflect effects of Placebo in the SFP/Placebo arm and effects of SFP in the Placebo/SFP arm., Pre-dialysis and post-dialysis during study week 5 of the Parent (Crossover) Study|Transferrin Saturation Change From Pre-dialysis to Post-dialysis at Week 2, Transferrin saturation (based on TIBC derived from transferrin levels) was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 2. Because of the crossover nature of the study, the week 2 values reflect effects of SFP in the SFP/Placebo arm and effects of Placebo in the Placebo/SFP arm., Pre-dialysis and post-dialysis during study week 2 of the Parent (Crossover) Study|Transferrin Saturation Change From Pre-dialysis to Post-dialysis at Week 5, Transferrin saturation (based on TIBC derived from transferrin levels) was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 5. Because of the crossover nature of the study, the week 5 values reflect effects of Placebo in the SFP/Placebo arm and effects of SFP in the Placebo/SFP arm., Pre-dialysis and post-dialysis during study week 5 of the Parent (Crossover) Study|Ferritin, The baseline and end of treatment predialysis ferritin levels were evaluated for the 52-week extension study to determine whether soluble ferric pyrophosphate increases iron stores., Baseline, up to 53 weeks for Extension Study|Serum Iron, The baseline and end of treatment predialysis serum iron levels were evaluated for the 52-week extension study to determine the effect of soluble ferric pyrophosphate on serum iron., Baseline, up to 53 weeks for Extension Study|Transferrin Saturation, The baseline and end of treatment predialysis transferrin saturation were evaluated for the 52-week extension study to confirm clearance of iron derived from soluble ferric pyrophosphate., Baseline, up to 53 weeks for Extension Study|Incidence of Patients Meeting Hy's Law Criteria, The peak alanine aminotransferase and the peak total bilirubin levels were evaluated per patient. Laboratory values for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Patients with alanine aminotransferase more than three times the upper limit of normal and also total bilirubin more than two times the upper limit of normal are counted., Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study
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| Locations: |
Mobile, Alabama, 36688, United States|Northridge, California, 91324, United States|Arvada, Colorado, 80002, United States|Westminster, Colorado, 80031, United States|Lauderhill, Florida, 33319, United States|Marietta, Georgia, 30060, United States|Chicago, Illinois, 60616, United States|Peoria, Illinois, 61603, United States|Columbus, Indiana, 47201, United States|Wichita, Kansas, 67214, United States|Baton Rouge, Louisiana, 70808, United States|Shreveport, Louisiana, 71101, United States|Camp Springs, Maryland, 20748, United States|Gulfport, Mississippi, 39501, United States|McComb, Mississippi, 39648, United States|Tupelo, Mississippi, 38801, United States|St. Peters, Missouri, 63376, United States|Lincoln, Nebraska, 68510, United States|Reno, Nevada, 89511, United States|Rocky Mount, North Carolina, 27804, United States|Dayton, Ohio, 45428, United States|Columbia, South Carolina, 29209, United States|Research Across America, Houston, Texas, 75234, United States|Houston, Texas, 77051, United States|Irving, Texas, 75061, United States|Mission, Texas, 78572, United States|Temple, Texas, 76508, United States|Tyler, Texas, 75701, United States|Courtice, Ontario, L1E 3C3, Canada|Montreal, Quebec, H3A 1A1, Canada|Regina, Saskatchewan, 54P 0W5, Canada
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