A Phase 3, Long-Term Safety Study of Subcutaneous Epoetin Hospira in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME -Anemia Management With Epoetin
CompletedPhase 3Results postedLast updated 18 March 2019
What this trial tests
Phase 3 trial testing Epoetin Hospira in Chronic Renal Failure Requiring Hemodialysis in 170 participants. Completed in 13 February 2015.
Adults 18 to 80, any sex, with Chronic Renal Failure Requiring Hemodialysis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Week 1Primary· Up through 7 days after first dose of study drug (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.
Group
Value
95% CI
Epoetin Hospira
17.4
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 12Primary· Week 1 up to Week 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.
Group
Value
95% CI
Epoetin Hospira
67.1
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 13 to 24Primary· Week 13 up to Week 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.
Group
Value
95% CI
Epoetin Hospira
60.5
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 25 to 36Primary· Week 25 up to Week 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.
Group
Value
95% CI
Epoetin Hospira
57.9
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 37 to 48Primary· Week 37 up to Week 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.
Group
Value
95% CI
Epoetin Hospira
48.5
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 48Primary· Week 1 up to Week 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.
Group
Value
95% CI
Epoetin Hospira
87.6
Mean Weekly Dosage of Epoetin Hospira: Over Week 1 to 48Secondary· Week 1 up to Week 48
Group
Value
95% CI
Epoetin Hospira
83.74
± 93.983
Mean Weekly Dosage of Epoetin Hospira for Interval of 12 WeeksSecondary· Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48
Week 1 to Week 12
Group
Value
95% CI
Epoetin Hospira
80.49
± 86.310
Week 13 to Week 24
Group
Value
95% CI
Epoetin Hospira
83.14
± 94.060
Week 25 to Week 36
Group
Value
95% CI
Epoetin Hospira
85.98
± 98.414
Week 37 to Week 48
Group
Value
95% CI
Epoetin Hospira
88.86
± 120.284
Mean Hemoglobin Levels: Over Week 1 to 48Secondary· Week 1 up to Week 48
Group
Value
95% CI
Epoetin Hospira
10.24
± 0.553
Mean Hemoglobin Levels for Interval of 12 WeeksSecondary· Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48
Week 1 to Week 12
Group
Value
95% CI
Epoetin Hospira
10.16
± 0.735
Week 13 to Week 24
Group
Value
95% CI
Epoetin Hospira
10.28
± 0.636
Week 25 to Week 36
Group
Value
95% CI
Epoetin Hospira
10.30
± 0.717
Week 37 to Week 48
Group
Value
95% CI
Epoetin Hospira
10.25
± 0.791
Mean Hematocrit Levels: Over Week 1 to 48Secondary· Week 1 up to Week 48
Hematocrit is defined as the percentage of red blood cells in the blood.
Group
Value
95% CI
Epoetin Hospira
32.22
± 2.091
Mean Hematocrit Levels for Interval of 12 WeeksSecondary· Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48
Hematocrit is defined as the percentage of red blood cells in the blood.
Week 1 to Week 12
Group
Value
95% CI
Epoetin Hospira
31.90
± 2.516
Week 13 to Week 24
Group
Value
95% CI
Epoetin Hospira
32.32
± 2.358
Week 25 to Week 36
Group
Value
95% CI
Epoetin Hospira
32.40
± 2.657
Week 37 to Week 48
Group
Value
95% CI
Epoetin Hospira
32.31
± 2.851
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT01628107 — A Phase 3, Long-Term Safety Study of Intravenous Epoetin Hospira in Patients With Chronic Renal Failure Requiring Hemodi
· Phase 3
· completed
NCT01473407 — A Phase 3 Study Comparing the Effects of Intravenous Epoetin Hospira and Epoetin Alfa [Epogen] (Amgen) in Patients With
· Phase 3
· completed
NCT01473420 — A Phase 3 Study Comparing the Effects of Subcutaneous Epoetin Hospira and Epoetin Alfa [Epogen] (Amgen) in Patients With
· Phase 3
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 18 March 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01628120.