Table 4.

Inclusion and exclusion criteria for DRIVE11

Inclusion criteria
    age 18 yr or older
    receiving chronic HD for at least 90 days
    TSAT ≤ 25%, serum ferritin 500 ng/ml to 1200 ng/ml, and Hb ≤ 11.0 g/dl
    epoetin dose ≥ 225 units/kg per wk or ≥22,500 units/wk, with no change in dose or method of administration for ≥14 days
    received no more than 125 mg of IV iron in any of the 4 wk preceding screening
Exclusion criteria
    use of any investigational agent within 30 days before first day of study treatment
    lactating or positive pregnancy test, if applicable
    known sensitivity to ferric gluconate or any of its components
    evidence of active infection requiring systemic antibiotic therapy at screening
    surgical procedure planned within the next 8 wk
    evidence of significant blood loss within the previous 6 wk
    history of sickle cell or sickled hemoglobin C disease or hematologic malignancies
    more than 3 missed hemodialysis treatments during the 8 wk before screening
    blood transfusion within the previous 4 wk before screening
    inpatient hospitalization within 2 wk before screening
  • HD, hemodialysis; TSAT, transferrin saturation; Hb, hemoglobin; IV, intravenous.