A Study of Once-Monthly Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia.

• Status: Withdrawn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

Summary

This single arm study will assess the long-term maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in hemodialysis patients with chronic renal anemia. Patients currently receiving darboepoetin alfa or epoetin alfa maintenance treatment will receive intravenous Mircera at a starting dose of 120, 200 or 360 micrograms/4 weeks (based on the ESA dose administered on week-1). Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10.5-12.5g/dL. 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;

• regular long-term hemodialysis therapy with the same mode of dialysis for >=3 months;

• continuous iv or sc maintenance ESA treatment during previous 2 months.

Exclusion Criteria:

• transfusion of red blood cells during previous 2 months;

• significant acute or chronic bleeding, such as overt gastrointestinal bleeding;

• active malignant disease (except non-melanoma skin cancer).