An Exploratory Study to Evaluate FMX-8 to Treat Anemia in CKD

Inclusion Criteria: * a documented hemoglobin level to be less than 10 g/dL at screening * diagnoses of CKD 4 or 5 * body mass index (BMI) between 18 kg/m2 and 42 kg/m2, inclusive, based upon the height and weight at screening * ferritin levels ≥100 ng/ml or Tsat ≥20% at screening * erythropoietin (EPO) level greater than 8 ng/mL * 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: * receipt of red blood cell (RBC) 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 * requiring Coumadin (warfarin), Pradaxa®, Eliquis®, 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 except topical corticosteroids or nasal sprays * 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 * previous exposure to Epogen®, Procrit® (erythropoietin) Aranesp® (darbepoietin alpha), Omontys® or Hematide® (peginesatide) anemia treatment * uncontrolled hyperparathyroidism (PTH \>750) based upon latest PTH determination within the past 4 months * inability to comply with the trial scheduled visits