A Phase 2A Trial of FMX-8 Treatment for Anemia in Patients With ESRD on Hemodialysis HD

Inclusion Criteria: * Male or female patients who are ≥18 years old * Diagnosed with ESRD and are stable on hemodialysis for more than 3 months * Maintained stable Hgb for ≥4 weeks prior to screening * Two consecutive Hgb values ≥10.5 g/dL within 5 weeks of screening * Body mass index (BMI) between 18 kg/m2 and 42 kg/m2, inclusive, based upon the latest height and weight * Ferritin levels ≥100 mg/L or Tsat ≥20% or reticulocyte hemoglobin content (CHr) \>25 at screening * Reasonable clearances on dialysis (KT/V ≥1.0) on two prior determinations within 2.5 months * Able to provide written informed consent * Able to understand and follow all trial procedures * Willing to use contraception as detailed in the protocol Exclusion Criteria: * Hgb remains unchanged without erythropoietin (\<0.5 g/dL decrease during the 8 week maximum erythropoietin-washout period) * Receipt of iron infusion after the initiation of erythropoietin washout * Receipt of red blood cell transfusion within four weeks before screening * Overt gastrointestinal bleeding or other bleeding episode that required transfusion within 2 months prior to screening * Infection necessitating antibiotic or anti-viral treatment within a month prior to screening * Requirement for Coumadin (warfarin), Pradaxa or Xarelto * Hemoglobinopathies such as homozygous sickle-cell disease or thalassemias of all types * Active hemolysis or chronic hypoxia * Active malignant diseases (except non-melanoma skin cancer) or life expectancy less than 6 months * Chronic, uncontrolled or symptomatic inflammatory disease or non-renal cause of anemia such as rheumatoid arthritis, systemic lupus erythematosus, HIV, or systemic acute infection * On immunosuppressive therapeutics * Chronic congestive heart failure (New York Heart Association Class III, IV) * Significant hypertension (≥90 diastolic) based on a sitting diastolic blood pressure at screening * Kidney transplant within the past year: patients who are off immunosuppressive agents following a failed transplant are eligible for the trial * End-stage liver disease * Known hypersensitivity to recombinant protein therapies * Female patients who are pregnant or breast feeding * Previous exposure to FMX-8 * Exposure to Omontys® or Hematide® (peginesatide) anemia treatment within the past 6 months * Treatment with Aranesp® (darbepoetin alpha) within the past 4 weeks * Uncontrolled hyperparathyroidism (PTH \>750) based upon latest PTH determination within the past 4 months * Inability to comply with the trial scheduled visits