Dynepo Infrequent Dosing Study

• Number of Patients Who Achieve Hb Levels of > or Equal to 11 g/dL [ Time Frame: week 16 and 24 ] [ Designated as safety issue: Yes ]
• Change From Baseline in Hematocrits at 16 and 24 Weeks [ Time Frame: Baseline and Weeks 16 and 24 ] [ Designated as safety issue: Yes ]

• Number (%) of patients who achieve Hb of >= 11g/dL at Week 12.
• Number (%) of patients who achieve the Haematocrit (Hct) target range of 33%-36% at Week 12.
• Number (%) of patients who achieve both Hb of >=11g/dL and the Hct target range of 33%-36% at Week 12.
• Patients' average weekly dose/kg over Weeks 9-12.
• Mean Hb concentration calculated over Weeks 13-24.
• Mean Hct calculated at Week 12 and over Weeks 13 to 24.
• Patients' average weekly dose/kg over Weeks 13 to 24.
• Number (%) of patients with a positive antibody response to Dynepo.
• Number (%) of patients shown to have neutralising antibodies.
• Blood pressure changes from Baseline.
• Changes in Left Ventricular Ejection Fraction from the Screening visit.
• Renal function using the estimated Glomerular Filtration Rate.
• Retinopathy in diabetic patients.

The purpose of this study is to demonstrate non-inferiority of efficacy between twice weekly and once weekly dose schedule of Dynepo in previously erythropoietin (EPO)-naive patients, as measured by haemoglobin at week 24 and secondly to demonstrate the non-inferiority of efficacy between once weekly and once every two weeks dose schedules of Dynepo in patients previously stable on EPO, as measured by Hb over Weeks 16 to 24.

• Anemia
• Kidney Failure

• Drug: Dynepo (Epoetin delta)
  subcutaneous, BIW for 24 weeks
• Drug: Dynepo
  subcutaneous, QW for 24 weeks
• Drug: Dynepo
  subcutaneous, Q2W for 24 weeks

• Active Comparator: 1
  Erythropoietin(EPO)-naive BIW
  Intervention: Drug: Dynepo (Epoetin delta)
• Active Comparator: 2
  EPO-naive QW
  Intervention: Drug: Dynepo
• Active Comparator: 3
  EPO QW
  Intervention: Drug: Dynepo
• Active Comparator: 4
  EPO Q2W
  Intervention: Drug: Dynepo

Inclusion Criteria:

• Aged at least 18 years with chronic kidney disease (Kidney Disease Outcomes Quality Initiative [KDOQI] stage III-V).
• Stable on and taking doses <= 10,000 IU/week of subcutaneous (sc) EPO or requiring initiation of EPO.
• Transferrin saturation >= 20% and ferritin >= 100 ng/mL.

Exclusion Criteria:

• Uncontrolled hypertension.
• Requiring doses of EPO > 10,000 IU/week.
• Two or more doses of prescribed EPO treatment missed ot withheld by physician order in the 14 days immediately prior tp randomisation in the study.
• Active bleeding disorder (diathesis) (for example, Gastrointestinal or Genitourinary tract bleeding).
• Treatment with immunosuppressive drugs (other than corticosteroids for a chronic condition) in the 30 days immediately prior to randomisation in the study.
• Androgen therapy in the 30 days immediately prior to randomisation in the study.
• Known Human Immunodeficiency Virus(HIV)infection.
• History of hypersensitivity to EPO therapy or to any of the excipients of Dynepo.