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

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate whether anemia prevention with NeoRecormon has an additional impact on reducing cardiovascular risk over conventional anemia treatment in patients mostly with stage IV chronic kidney disease and renal anemia. The anticipated time on study treatment is 2+ years and the target sample size is 500+ individuals.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• adult patients >=18 years of age;

• chronic renal anemia;

• not receiving renal replacement therapy.

Exclusion Criteria:

• women who are pregnant or lactating;

• previous treatment with erythropoietin or other erythropoietic substance;

• blood transfusion within the last 3 months;

• need for dialysis expected in the next 6 months;

• administration of another investigational drug within 30 days preceding study start, or during the study.