Anemia Clinical Trial
Official title:
"A Single Arm, Open Label Study Evaluating Once-monthly Subcutaneous Mircera for the Maintenance of Hemoglobin Levels in Pre-dialysis Patients With Chronic Renal Anemia"
This single arm study will assess the long term maintenance of hemoglobin levels, safety and tolerability of once monthly subcutaneous Mircera in predialysis patients with chronic renal anemia. Patients currently receiving subcutaneous darbopoetin alfa maintenance treatment will receive subcutaneous Mircera for a maximum of 32 weeks at a starting dose of 120, 200 or 360 micrograms every 4 weeks according to the dose of darbopoetin alfa administered in week -1. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10 to 12 g/dL. The anticipated time on study treatment is 3-12 months, and the target sample size if 100-500 individuals.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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