To determine the long term safety in treatment-emergent adverse events (TEAEs) of SC administration of Epoetin Hospira for maintenance of target hemoglobin (Hgb) levels in patients treated for anemia associated with chronic renal failure and on hemodialysis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
170
Subcutaneous(SC) injection
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Week 1
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
Time frame: Up through 7 days after first dose of study drug (Week 1)
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 12
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
Time frame: Week 1 up to Week 12
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 13 to 24
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
Time frame: Week 13 up to Week 24
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 25 to 36
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
Time frame: Week 25 up to Week 36
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 37 to 48
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
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Azusa Dialysis Center
Azusa, California, United States
Unnamed facility
Azusa, California, United States
Pegasus Dialysis
Bakersfield, California, United States
National Institute of Clinical Research
Bakersfield, California, United States
Unnamed facility
Bakersfield, California, United States
Bellflower Dialysis Center
Bellflower, California, United States
Unnamed facility
Granada Hills, California, United States
Lakewood Dialysis Center
Lakewood, California, United States
Westcoast Dialysis
Long Beach, California, United States
Long Beach Dialysis
Long Beach, California, United States
...and 105 more locations
Time frame: Week 37 up to Week 48
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 48
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
Time frame: Week 1 up to Week 48
Mean Weekly Dosage of Epoetin Hospira: Over Week 1 to 48
Time frame: Week 1 up to Week 48
Mean Weekly Dosage of Epoetin Hospira for Interval of 12 Weeks
Time frame: Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48
Mean Hemoglobin Levels: Over Week 1 to 48
Time frame: Week 1 up to Week 48
Mean Hemoglobin Levels for Interval of 12 Weeks
Time frame: Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48
Mean Hematocrit Levels: Over Week 1 to 48
Hematocrit is defined as the percentage of red blood cells in the blood.
Time frame: Week 1 up to Week 48
Mean Hematocrit Levels for Interval of 12 Weeks
Hematocrit is defined as the percentage of red blood cells in the blood.
Time frame: Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48
Percentage of Participants With Hemoglobin Level Outside Target Range
Percentage of participants with hemoglobin level outside the target range of 9.0 to 11.0 g/dL were reported.
Time frame: Week 1 up to Week 48
Percentage of Participants Who Received Blood Transfusions
Time frame: Week 1 up to Week 48