Table 1 Major selection criteria

• Patients aged at least 18 years of age with CKD (KDOQI Stage 3–5) who are able to give written informed consent and are likely to attend all study visits

• Stable on any dose ≤ 10 000 IU/week of subcutaneous ESA or requiring initiation of ESA treatment

• Those currently receiving ESA treatment must have been receiving a stable dose, that was effective in managing haemoglobin levels (≥ 11 g/dL), for at least 30 days before randomization in the study

• Those requiring initiation of ESA treatment must have haemoglobin levels ≥ 8 g/dL and < 11 g/dL

• Transferrin saturation ≥ 20 % and ferritin ≥ 100 ng/mL

Major exclusion criteria

• Uncontrolled hypertension

• Requiring doses of ESA > 10 000 IU/week

• Two or more doses of prescribed ESA treatment missed or withheld by physician order in the 14 days immediately before randomization in the study

• Thrombocytopenia (platelet count < 75 000/mm³)

• Active bleeding disorder (diathesis) (for example, gastro-intestinal or genito-urinary tract bleeding)

• Treatment with immunosuppressive drugs (other than corticosteroids for a chronic condition) in the 30 days immediately before randomization in the study

• Androgen therapy in the 30 days immediately before randomization in the study

• Known HIV infection from medical history

• Known or suspected intolerance or hypersensitivity to ESA therapy or to any of the excipients of epoetin delta

• Known to have antibodies against erythropoietin

• Impaired hepatic function (AST, ALT > 3x ULN)