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

A Phase 2A, Uncontrolled, Open-labeled Trial to Evaluate the Effect of FMX-8 Treatment for Anemia in Patients With End Stage Renal Disease (ESRD) on Hemodialysis (HD)

The trial is an uncontrolled, open-label, parallel group clinical trial. Approximately 10 subjects per dose group in 3 groups will be treated twice weekly for a total of 9 doses, followed by a 4-week observation period. Eligible subjects who have Hgb ≥10.5 g/dL and have stable Hgb levels will start the washout period of one to eight weeks. During the washout period, 30 subjects whose Hgb are < 10.0 will complete the baseline assessment to confirm their eligibility. Eligible subjects will be randomly assigned to one of the 3 cohorts in a 1:1:1 ratio. Subjects will be admitted on the day of the first dose and stay in the clinic overnight for pharmacokinetic (PK) sampling after the first (day 1) and the last dose (day 29). FMX-8 will be administered as 30 min i.v. infusion. After the 29-day treatment period, the trial subjects will be observed for an additional 28 days to allow safety and immunogenicity assessments.

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