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

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Epoetin Alfa

Criteria

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