Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
FerruMax Pharmaceuticals, Inc.
With
Davita Clinical Research
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Phase 2A Trial of FMX-8 Treatment for Anemia in Patients With ESRD on Hemodialysis HD
