An Exploratory Study to Evaluate FMX-8 to Treat Anemia in CKD
- Registration Number
- NCT02228655
- Lead Sponsor
- FerruMax Pharmaceuticals, Inc.
- Brief Summary
FMX-8 is a new type of drug being tested for the treatment of anemia in chronic illnesses.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FMX-8 FMX-8 FMX-8 for injection, 15mg/kg, twice weekly, 29 days
- Primary Outcome Measures
Name Time Method Change in hemoglobin concentration 57 day evaluation period
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States