This study will assess the efficacy and safety of Mircera given intravenously in the treatment of renal anemia in chronic kidney disease patients on dialysis who are not currently 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
182
3 times a week iv, as prescribed.
0.4 micrograms/kg iv (starting dose) once every 2 weeks
Hemoglobin response rate
Time frame: Weeks 1-24
Hb over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, AEs, laboratory values\n
Time frame: Throughout study
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Davis, California, United States
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Lakewood, Colorado, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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New Orleans, Louisiana, United States
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Boston, Massachusetts, United States
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Springfield, Massachusetts, United States
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Detroit, Michigan, United States
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Mineola, New York, United States
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New York, New York, United States
...and 49 more locations