This study will assess the efficacy and safety of subcutaneous Mircera in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
324
0.45 micrograms/kg sc (starting dose) weekly
0.6 micrograms/kg sc (starting dose) once every 2 weeks
Hemoglobin response rate
Time frame: Weeks 1-28
Hb concentration over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, adverse events, laboratory values\n\n
Time frame: Throughout study
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Los Angeles, California, United States
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Mather, California, United States
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Stanford, California, United States
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Stamford, Connecticut, United States
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Bay Pines, Florida, United States
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Ocala, Florida, United States
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Shreveport, Louisiana, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
...and 88 more locations