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