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

• Status: Terminated
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FerruMax Pharmaceuticals, Inc.

Criteria

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