| Outcome Measures: |
Primary: The proportion of subjects who achieve an increase in Hgb ≥ 1g/dL from the lowest Hgb concentration post erythropoietin-washout or continuing rise in Hgb concentration for two consecutive weeks, Weekly for 8 weeks|Number and Severity of Adverse Events, 8 weeks|Serum FMX-8 levels, Serum drug levels (pre-dose, and 25 minutes, 35 minutes, 1, 2, 4, 6, 10, 16 and 24 hrs post-dose) will be used to determine, for each dose, standard pK profiles, Dosing Days 1 and 29|Number of Subjects with Positive Serum for Anti-Drug Antibodies, At 36 and 57 days after first dose of FMX-8 | Secondary: Changes in Hgb in each dose group during the treatment and follow-up periods, Weekly for 8 weeks|Proportion of subjects that achieve/maintain an absolute Hgb concentration of ≥ 10.0 g/dL for two consecutive weeks, Weekly for 8 weeks|Time to beginning of steady increase of Hgb (for two consecutive weeks), Weekly for 8 weeks|Time to Hgb increase ≥1 g/dL, Weekly for 8 weeks|Time to full recovery of Hgb to pre- erythropoietin-washout level, Weekly for 8 weeks|Proportion of subjects needing erythropoietin rescue and length of time to start of rescue therapy, Weekly for 8 weeks|Change of hepcidin and erythropoietin, At weeks 2, 4, 6 and 8 from baseline|Changes in Serum Iron, Tsat and plasma Ferritin, At weeks 2, 4, 6 and 8 compared to baseline
|
| Locations: |
DaVita Arvada Dialysis Center, Arvada, Colorado, 80005, United States|DaVita Minneapolis Dialysis Unit, Minneapolis, Minnesota, 55404, United States
|
