This study will assess the efficacy and safety of methoxy polyethylene glycol-epoetin beta (Mircera) in the maintenance of hemoglobin levels in patients who have previously received treatment with epoetin alfa or darbepoetin alfa, and who are transitioning from chronic kidney disease stage 4 through dialysis. Patients will be randomized either to receive Mircera or to remain on their existing therapy; the initial monthly dose of subcutaneous (sc) Mircera (120-360 micrograms) will be based on the average weekly dose of epoetin alfa or darbepoetin alfa administered in the week preceding the switch to Mircera. At the initiation of dialysis, patients in the Mircera group will receive monthly intravenous (iv) Mircera at a starting dose based on their previous (sc) dose, and those in the control group will receive weekly (iv) epoetin alfa. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
111
Methoxy polyethylene glycol-epoetin beta was provided as a sterile single-use injectable solution in a 1-mL prefilled syringe containing 0.3 mL or 0.6 mL solution. The methoxy polyethylene glycol-epoetin beta injectable solution was formulated in sodium phosphate, sodium sulfate, mannitol, methionine and poloxamer 188, pH 6.2 and did not contain any preservative. Participants received methoxy polyethylene glycol-epoetin beta subcutaneous once a month.
Standard of care as prescribed, per individual participant, subcutaneous once per week. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.
Standard of care as prescribed, per individual participant, darbepoetin alfa subcutaneous once every two weeks. Subcutaneous injections were to be administered in the same part of the body (ie, thigh,abdomen or arm) throughout the study.
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Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Phoenix, Arizona, United States
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El Dorado, Arkansas, United States
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Hot Springs, Arkansas, United States
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Percentage of Patients Able to Maintain Hemoglobin (Hb) Within 10-12 g/dL
Efficacy analyses were not performed.
Time frame: 6-7 months post initiation of dialysis
Dose Adjustments
Efficacy analyses were not performed.
Time frame: 5 months post-randomization through onset of dialysis, and post-dialysis initiation through study end.
Number of Participants Assessed for AEs and SAEs
The adverse events are captured in the adverse event and serious adverse event section of this database.
Time frame: First dose of medication through 15 days post last dose (up to 8 months)
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Bakersfield, California, United States
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Glendale, California, United States
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Granada Hills, California, United States
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Los Angeles, California, United States
Unnamed facility
Orange, California, United States
...and 68 more locations