Iron Indices and Intravenous Ferumoxytol: Time to Steady State
Condition: Iron Deficiency Anemia
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Intervention: ferumoxytol
Intervention description: 510 milligram (mg) intravenous (IV) injection (30 mg/second (sec) over 17 seconds) after at least one hour of hemodialysis (HD), second 510 mg IV injection administered at next consecutive dialysis treatment (3-5 days after first injection)
Intervention MeSH terms: Ferrosoferric Oxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the time point of transferrin saturation (TSAT) and
      ferritin stabilization after a thirteen-treatment period following a ferumoxytol load, as
      well as to determine the point at which serum ferritin and TSAT concentrations can be checked
      in iron deficiency anemia (IDA) hemodialysis patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic hemodialysis subjects who have received dialysis treatment for more than 90
             days

          -  TSAT less than or equal to 25 percent

          -  Serum ferritin less than or equal to 200 nanograms/milliliter (ng/mL)

          -  (Female) Subjects are willing to use reliable contraception, or have undergone
             menopause (chemical or surgical)

          -  Subjects who are able to read and write in English

          -  Subjects who have signed consent

        Exclusion Criteria:

          -  Subjects who have been enrolled in a clinical trial within the past 30 days

          -  Subjects who have received IV iron within 4 weeks of the start of the study

          -  Serum ferritin greater than or equal to 1200 ng/dL

          -  Hemoglobin (Hb) less than 10 grams/deciliter (g/dL), or greater than 13.5 g/dL

          -  Evidence of iron overload

          -  Known hypersensitivity to ferumoxytol or any of its components

          -  Anemia caused by conditions other than iron deficiency

          -  Subjects with elective surgeries scheduled within the next 3 months

          -  Subjects with elective magnetic resonance procedure scheduled during the study period

          -  Subjects who have been hospitalized within the past 30 days (excluding vascular access
             care)

          -  Subjects who have received a blood transfusion in the past 30 days

          -  Subjects who are transfusion dependent

          -  (Female) Subjects who are pregnant or nursing

          -  Subjects with known inflammatory conditions which may affect serum ferritin

          -  Subjects who are considered to be clinically unstable at the discretion of Principal
             Investigator (P.I.)

          -  Subjects who have a clinically unstable blood pressure (BP) of systolic greater than
             180 millimeters of mercury (mmHg) and/or diastolic greater than 100 mmHg (sitting,
             pre-dialysis)

          -  Subjects with life expectancy less than 6 months

          -  Subjects who refuse to sign consent