A Study of Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia

• Status: Completed
• Trial end date: 2010-06-22
• Target enrollment: 0
• Participant gender: All

Summary

This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Patients will receive 4-weekly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 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;

• continuous stable iv or sc maintenance epoetin therapy during previous 4 weeks;

• regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months.

Exclusion Criteria:

• transfusion of red blood cells during previous 2 months;

• poorly controlled hypertension requiring hospitalization or interruption of epoetin treatment in previous 6 months;

• significant acute or chronic bleeding.