Table 3 Criteria for evaluation
Primary objectives |
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• Mean haemoglobin concentration at Week 24 and over Weeks 16–24 |
Secondary objectives |
• Number (%) of patients who achieve haemoglobin of ≥ 11 g/dL at Weeks 16 and 24 and over Weeks 16–24 • Mean haematocrit concentration calculated at Weeks 16 and 24 and over Weeks 16–24 • Number (%) of patients who achieve the haematocrit target range of 33–36% at Weeks 16 and 24 and over Weeks 16–24 • Patients' average weekly dose/kg over Weeks 9–16, 16–24 and 9–24 • Mean haemoglobin concentration calculated at Week 16 • Number (%) of patients who achieve both haemoglobin of ≥ 11 g/dL and the haematocrit target range of 33–36% at Weeks 16 and 24 and over Weeks 16–24 • Number (%) of patients with a positive antibody response to epoetin delta • Number (%) of patients shown to have neutralizing antibodies • Blood pressure changes from baseline • Changes in left ventricular ejection fraction from the screening visit • Renal function using estimated glomerular filtration rate • Retinopathy in diabetic patients |