A Study of Mircera (C.E.R.A.) in Patients With Pre-Dialysis Chronic Renal Anemia

A Single Arm, Open Label, Multicenter Phase IIIb/IV Clinical Trial to Assess the Efficacy, Safety and Tolerability of Monthly Administration of C.E.R.A. for the Treatment of Not on Dialysis Chronic Renal Anemia Not Currently Treated With ESA

This single arm, open label, multicenter study will evaluate the safety and change in hemoglobin levels of Mircera (C.E.R.A.; methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia who are not on dialysis. Patients will receive as a recommended starting dose 1.2 micrograms of Mircera subcutaneously every 4 weeks. The starting dose is dependent on the patient's weight. Dose adjustment may be required due to inadequate or excessive treatment response. The anticipated time on study treatment is 28 weeks.

Inclusion Criteria:

• Adult patients, age >/=18 years
• Diagnosis of chronic renal anemia
• Not on dialysis
• Hemoglobin concentration <10 g/dl
• No erythropoiesis stimulating agent (ESA) therapy during the 3 months before study start
• Estimated glomerular filtration rate (EGFR) <60 ml/min and >/=20 ml/min
• Adequate iron status

Exclusion Criteria:

• Transfusion of red blood cells during the previous 2 months
• Poorly controlled hypertension
• Significant acute or chronic bleeding, e.g. gastrointestinal bleeding
• Active malignant disease (except non-melanoma skin cancer)
• Hemolysis
• Hemoglobinopathies, e.g. sickle-cell disease, thalassemia