Status:
TERMINATED
An Exploratory Study to Evaluate FMX-8 to Treat Anemia in CKD
Lead Sponsor:
FerruMax Pharmaceuticals, Inc.
Conditions:
Anemia in Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
FMX-8 is a new type of drug being tested for the treatment of anemia in chronic illnesses.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT02228655
Start Date
October 1 2014
End Date
July 1 2015
Last Update
February 2 2016
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215