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

An Exploratory, Uncontrolled, Open-labeled Trial to Evaluate the Effect of FMX-8 Treatment for Anemia in Patients With Chronic Kidney Disease (CKD), Stage 4 or 5

FMX-8 is a new type of drug being tested for the treatment of anemia in chronic illnesses.

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