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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
120, 200 or 360 micrograms / 4 weeks iv (starting dose)
Unnamed facility
Aalborg, Denmark
Unnamed facility
Fredericia, Denmark
Unnamed facility
Roskilde, Denmark
Percentage of patients maintaining average Hb concentration within target range during evaluation period
Time frame: Weeks 17-24
Change in Hb concentration between reference and evaluation period; mean time spent in, and percentage of patients maintaining Hb within target range
Time frame: Weeks 17-24
Dose adjustments; RBC transfusions
Time frame: Throughout study
AEs, laboratory parameters, vital signs
Time frame: Throughout study
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