This study will assess the efficacy and safety of intravenous (iv) or subcutaneous (sc) Mircera, administered with pre-filled syringes, as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv or sc epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
336
iv or sc, as prescribed
30, 50 or 90 micrograms iv or sc (starting dose) every 2 weeks
Change in hemoglobin concentration
Time frame: Weeks 1-36
Number of patients maintaining average Hb concentration within +/- 1g/dL of average baseline Hb concentration
Time frame: Weeks 29-36
RBC transfusions
Time frame: Weeks 1-36
AEs, laboratory parameters, vital signs
Time frame: Throughout study
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Covina, California, United States
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Los Alamitos, California, United States
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Los Angeles, California, United States
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San Diego, California, United States
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San Diego, California, United States
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Tampa, Florida, United States
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Honolulu, Hawaii, United States
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South Holland, Illinois, United States
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Baton Rouge, Louisiana, United States
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Shreveport, Louisiana, United States
...and 56 more locations