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

FerruMax Pharmaceuticals

Status and phase

Terminated

Early Phase 1

Conditions

Anemia in Chronic Kidney Disease

Treatments

Drug: FMX-8

Study type

Interventional

Funder types

Industry

Identifiers

NCT02228655

FX-C-888

Details and patient eligibility

About

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

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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