Table 1.

Major inclusion and exclusion criteriaa

Inclusion CriteriaExclusion Criteria
Adult patients (≥18 yr of age) with chronic renal anemiaOvert gastrointestinal bleeding or any other bleeding episode necessitating transfusion within 8 wk before screening or during screening/baseline
Regular long-term HD or PD therapy with the same mode of dialysis for at least 12 wk before screening and during screening/baselineRBC transfusions within 8 wk before screening or during screening/baseline
Kt/V ≥1.2 or urea reduction ratio ≥65% for HD patients or weekly Kt/V ≥1.8 for PD patientsNonrenal causes of anemia (e.g., folic acid or vitamin B12 deficiency, hemolysis, hemoglobinopathies [e.g., homozygous sickle-cell disease, thalassemia of all types])
Baseline Hb concentration between 10.5 and 13.0 g/dl (mean of the weekly Hb values determined in weeks −4 to −1)Acute infection or chronic, uncontrolled or symptomatic inflammatory disease (e.g., rheumatoid arthritis, systemic lupus erythematosus)
Stable baseline Hb concentration (defined as an absolute difference ≤1 g/dl between the mean Hb values determined in weeks −4 and −3 and the mean Hb values determined in weeks −2 and −1)C-reactive protein >30 mg/L
Continuous subcutaneous maintenance epoetin therapy (epoetin α formulated with human albumin or epoetin β) with the same dosing interval for at least 8 wk before screening and during screening/baselinePoorly controlled hypertension necessitating interruption of epoetin treatment in the 6 mo before screening
Stable subcutaneous maintenance epoetin therapy during screening/baseline (no change of the weekly dosage)Platelets >500 × 109/L
Adequate iron status defined as serum ferritin ≥100 ng/ml or transferrin saturation ≥20% (or hypochromic RBCs <10%; mean of two values determined in weeks −4 and −3)Pure red cell aplasia
Chronic congestive heart failure (New York Heart Association class IV)
High likelihood of early withdrawal/interruption of the study (myocardial infarction, severe or unstable coronary artery disease, stroke, severe liver disease within the 12 wk before screening or during screening/baseline)
Life expectancy <12 mo
  • a Hb, hemoglobin; HD, hemodialysis; PD, peritoneal dialysis; RBC, red blood cell.