An Open Label Study to Assess the Maintenance of Hemoglobin Levels, Safety and Tolerability of Once Monthly Administration of Mircera in Hemodialysis Patients With Chronic Renal Anemia.
Overview
- Phase
- Phase 3
- Intervention
- methoxy polyethylene glycol-epoetin beta
- Conditions
- Anemia
- Sponsor
- Hoffmann-La Roche
- Primary Endpoint
- Percentage of patients maintaining average Hb concentration within target range during evaluation period
- Status
- Withdrawn
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
Eligibility 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).
Arms & Interventions
1
Intervention: methoxy polyethylene glycol-epoetin beta
Outcomes
Primary Outcomes
Percentage of patients maintaining average Hb concentration within target range during evaluation period
Time Frame: Weeks 17-24
Secondary Outcomes
- Change in Hb concentration between reference and evaluation period; mean time spent in, and percentage of patients maintaining Hb within target range(Weeks 17-24)
- Dose adjustments; RBC transfusions(Throughout study)
- AEs, laboratory parameters, vital signs(Throughout study)