A Study of Two-Weekly Intravenous Mircera for the Treatment of Dialysis Patients With Chronic Renal Anemia Not Receiving ESA Therapy.

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This single arm study will evaluate the hemoglobin (Hb) increasing effect, safety and tolerability of two-weekly intravenous administration of Mircera in dialysis patients with chronic renal anemia not currently treated with ESAs. Patients will receive intravenous Mircera 0.6 micrograms/kg every 2 weeks for 16 weeks with follow up 2 weeks after the last treatment visit. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

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

Details

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

Criteria

Inclusion Criteria:

• male or female patients, >=18 years of age;

• chronic renal anemia (Hb concentration 8.0g/dL - 10.0g/dL);

• no prior erythropoietin stimulating agent (ESA) therapy.

Exclusion Criteria:

• blood transfusion within the previous 4 weeks;

• poorly controlled hypertension;

• significant acute or chronic bleeding;

• active malignant disease;

• congestive heart failure (NYHA Class IV).