A Study of Epoetin Beta (NeoRecormon) in Predialysis Patients With Renal Anemia

An Open-Label Study of the Tolerability and Flexibility of Multi-Dose NeoRecormon Administered by Reco-Pen in Pre-Dialysis Patients With Chronic Renal Anemia.

This study will evaluate the tolerability, and effect on quality of life, in patients receiving multi-dose NeoRecormon administered by RecoPen in predialysis patients with chronic renal anemia. The anticipated time on study treatment is 10 months, and the target sample size is 60 individuals.

Inclusion Criteria:

• Adult patients 18-65 years of age
• Chronic renal failure (Stages I-III)
• No previous epoetin therapy

Exclusion Criteria:

• Poorly controlled hypertension
• History or evidence of malignancy
• Relevant acute or chronic bleeding (requiring therapy) within 3 months before study drug
• Women who are pregnant or breastfeeding