Table 1.

Major inclusion and exclusion criteriaa

Inclusion criteria
    Adult patients (≥18 yr of age) who had stage 3 (CrCl 30 to 59 ml/min) or stage 4 CKD (CrCl 15 to 29 ml/min) and did not require dialysis
    Anemia defined as baseline Hb concentration between 8 and 11 g/dl, determined from the mean of two screening values with at least 1 d between measurements
    Adequate iron status defined as serum ferritin ≥100 ng/ml or TSAT ≥20% (or percentage of hypochromic RBCs <10%); mean of two screening values with at least 1 d between measurements
Exclusion criteria
    Need for dialysis therapy expected in the next 6 mo or rapid progression of CKD (e.g., a CrCl decrease of >20% within 12 wk)
    Previous therapy with any ESA within 12 wk before screening
    Immunosuppressive therapy (other than corticosteroids for a chronic condition, cyclosporine, and monoclonal/polyclonal antibodies) in the 12 wk before screening
    Overt gastrointestinal bleeding or any other bleeding episode necessitating transfusion within 8 wk before screening or during the screening period
    RBC transfusions within 8 wk before screening or during the screening period
    Nonrenal causes of anemia (e.g., hemoglobinopathies [e.g., homozygous sickle cell disease, thalassemia of all types], hemolysis, vitamin B12 or folic acid deficiency)
    Active malignant disease (except non-melanoma skin cancer)
    Chronic, uncontrolled or symptomatic inflammatory disease (e.g., rheumatoid arthritis, systemic lupus erythematosus)
    C-reactive protein >15 mg/L
    Poorly controlled hypertension (sitting SBP ≥170 mmHg or DBP ≥100 mmHg)
    Pure red cell aplasia
    Platelets >500 × 109/L
    Chronic congestive heart failure (New York Heart Association class IV)
    High likelihood of early withdrawal or interruption of the study (e.g., myocardial infarction, severe or unstable coronary artery disease, stroke, severe liver disease within the 12 wk before screening or occurring during the screening/baseline period)
    Planned elective surgery during the next 7 mo (except laser photocoagulation)
    Life expectancy <12 mo
  • a CKD, chronic kidney disease; CrCl, creatinine clearance; DBP, diastolic BP; ESA, erythropoiesis-stimulating agent; Hb, hemoglobin; RBC, red blood cell; SBP, systolic BP; TSAT, transferrin saturation.