Trial Outcomes & Findings for A Phase 3 Study Comparing the Effects of Intravenous Epoetin Hospira and Epoetin Alfa [Epogen] (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin (NCT NCT01473407)

NCT ID: NCT01473407

Last Updated: 2018-09-10

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

612 participants

Primary outcome timeframe

Week 21 up to Week 24

Results posted on

2018-09-10

Participant Flow

Participants with chronic renal failure were receiving Epoetin maintenance therapy prior to enrollment and treatment in this study.

Participant milestones

Participant milestones
Measure	Epoetin Hospira Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28.	Epogen Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28.
Overall Study STARTED	306	306
Overall Study COMPLETED	252	259
Overall Study NOT COMPLETED	54	47

Reasons for withdrawal

Reasons for withdrawal
Measure	Epoetin Hospira Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28.	Epogen Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28.
Overall Study Physician Decision	1	4
Overall Study Lost to Follow-up	10	4
Overall Study Adverse Event	8	8
Overall Study Randomization Error	3	1
Overall Study Withdrawal by Subject	4	7
Overall Study Kidney Transplant	7	6
Overall Study Vacation/Travel	1	1
Overall Study Elevated Hemoglobin	1	0
Overall Study Patient Received Aranesp	1	0
Overall Study Patient Lost Green Card Status	1	0
Overall Study Temperature Excursion	2	3
Overall Study Transfer to Another Facility/Unit	4	3
Overall Study Sponsor's Decision	10	10
Overall Study Site Closure	1	0

Baseline Characteristics

A Phase 3 Study Comparing the Effects of Intravenous Epoetin Hospira and Epoetin Alfa [Epogen] (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Epoetin Hospira n=306 Participants Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28.	Epogen n=306 Participants Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28.	Total n=612 Participants Total of all reporting groups
Age, Continuous	55.32 years STANDARD_DEVIATION 13.057 • n=5 Participants	57.35 years STANDARD_DEVIATION 11.440 • n=7 Participants	56.34 years STANDARD_DEVIATION 12.307 • n=5 Participants
Sex: Female, Male Female	146 Participants n=5 Participants	131 Participants n=7 Participants	277 Participants n=5 Participants
Sex: Female, Male Male	160 Participants n=5 Participants	175 Participants n=7 Participants	335 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 21 up to Week 24

Population: ITT population included all participants who were randomized to study treatment.

Outcome measures

Outcome measures
Measure	Epoetin Hospira n=306 Participants Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28.	Epogen n=306 Participants Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28.
Mean Weekly Hemoglobin Level From Week 21 to Week 24	10.17 g/dL Standard Deviation 0.847	10.28 g/dL Standard Deviation 0.839

PRIMARY outcome

Timeframe: Week 21 up to Week 24

Population: ITT population included all participants who were randomized to study treatment. Here, "Number of Participants Analyzed (N)" signifies those participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Epoetin Hospira n=305 Participants Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28.	Epogen n=305 Participants Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28.
Mean Weekly Dosage of Study Medication From Week 21 to Week 24	89.61 unit per kilogram per week (U/kg/week) Standard Deviation 99.824	90.37 unit per kilogram per week (U/kg/week) Standard Deviation 88.492

SECONDARY outcome

Timeframe: Week 1 up to Week 24

Population: ITT population included all participants who were randomized to study treatment. Here, "N" signifies number of participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Epoetin Hospira n=302 Participants Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28.	Epogen n=305 Participants Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28.
Mean Weekly Hemoglobin Level Through 24 Weeks	10.25 g/dL Standard Deviation 0.591	10.26 g/dL Standard Deviation 0.597

SECONDARY outcome

Timeframe: Week 1 up to Week 24

Population: ITT population included all participants who were randomized to study treatment. Here, "N" signifies number of participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Epoetin Hospira n=301 Participants Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28.	Epogen n=305 Participants Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28.
Mean Weekly Dosage of Study Medication Through 24 Weeks	87.51 U/kg/week Standard Deviation 86.405	90.95 U/kg/week Standard Deviation 80.619

SECONDARY outcome

Timeframe: Week 1 up to Week 24

Population: ITT population included all participants who were randomized to study treatment. Here, "N" signifies number of participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Epoetin Hospira n=301 Participants Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28.	Epogen n=305 Participants Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28.
Total Dose of Study Medication Administered	146752.6 units of study medication Standard Deviation 156128.97	147145.2 units of study medication Standard Deviation 141911.73

SECONDARY outcome

Timeframe: Week 12, 24

Population: ITT population included all participants who were randomized to study treatment.

Percentage of participants who had hemoglobin level within the target range of 9 to 11 g/dL for the specified weeks were reported.

Outcome measures

Outcome measures
Measure	Epoetin Hospira n=306 Participants Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28.	Epogen n=306 Participants Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28.
Percentage of Participants With Mean Weekly Hemoglobin Level Within the Target Range Week 12	81.0 percentage of participants 156128.97	73.2 percentage of participants 141911.73
Percentage of Participants With Mean Weekly Hemoglobin Level Within the Target Range Week 24	73.2 percentage of participants	71.4 percentage of participants

SECONDARY outcome

Timeframe: Week 1 up to Week 24

Population: Per protocol population was a subset of ITT participants who did not have major protocol violations.

Outcome measures

Outcome measures
Measure	Epoetin Hospira n=204 Participants Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28.	Epogen n=192 Participants Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28.
Percentage of Participants Who Required Permanent Dose Changes of Study Medication	86.3 percentage of participants 156128.97	93.2 percentage of participants 141911.73

SECONDARY outcome

Timeframe: Week 1 up to Week 24

Population: Per protocol population was a subset of ITT participants who did not have major protocol violations.

Outcome measures

Outcome measures
Measure	Epoetin Hospira n=204 Participants Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28.	Epogen n=192 Participants Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28.
Percentage of Participants Who Required Temporary Dose Changes of Study Medication	7.4 percentage of participants 156128.97	4.2 percentage of participants 141911.73

SECONDARY outcome

Timeframe: Week 1 up to Week 24

Population: Per protocol population was a subset of ITT participants who did not have major protocol violations.

Outcome measures

Outcome measures
Measure	Epoetin Hospira n=204 Participants Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28.	Epogen n=192 Participants Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28.
Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 1 Gram Per Deciliter (g/dL)	44.1 percentage of participants 156128.97	43.2 percentage of participants 141911.73

SECONDARY outcome

Timeframe: Week 12, 24

Population: ITT population included all participants who were randomized to study treatment.

Percentage of participants who had hemoglobin level outside the target range of 9 to 11 g/dL for the specified weeks were reported.

Outcome measures

Outcome measures
Measure	Epoetin Hospira n=306 Participants Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28.	Epogen n=306 Participants Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28.
Percentage of Participants With Mean Weekly Hemoglobin Level Outside the Target Range Week 12	19.0 percentage of participants	26.8 percentage of participants
Percentage of Participants With Mean Weekly Hemoglobin Level Outside the Target Range Week 24	26.8 percentage of participants	28.6 percentage of participants

SECONDARY outcome

Timeframe: Week 1 up to Week 24

Population: ITT population included all participants who were randomized to study treatment. Here, "N" signifies number of participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Epoetin Hospira n=303 Participants Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28.	Epogen n=305 Participants Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28.
Percentage of Participants Who Received Blood Transfusions	6.3 percentage of participants 156128.97	5.9 percentage of participants 141911.73

SECONDARY outcome

Timeframe: Week 1 up to Week 24

Population: ITT population included all participants who were randomized to study treatment. Here, "N" signifies number of participants who were evaluable for this outcome measure.

In this outcome measure number of participants with change (increase and decrease) in mean dose of Epoetin Hospira and Epogen were categorized and reported according to their mean hemoglobin levels. Hemoglobin levels were divided in following classes: \>11.0 g/dL, from 9.0 to 11.0 g/dL and \<9.0 g/dL

Outcome measures

Outcome measures
Measure	Epoetin Hospira n=301 Participants Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28.	Epogen n=305 Participants Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28.
Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level Dose Decrease: Hb <9.0 g/dL	49 Participants 156128.97	37 Participants 141911.73
Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level Dose Decrease: Hb (9 to 11 g/dL)	49 Participants	46 Participants
Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level Dose Decrease: Hb >11.0 g/dL	147 Participants	150 Participants
Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level Dose Increase: Hb <9.0 g/dL	50 Participants	67 Participants
Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level Dose Increase: Hb (9 to 11 g/dL)	27 Participants	26 Participants
Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level Dose Increase: Hb >11.0 g/dL	36 Participants	54 Participants

SECONDARY outcome

Timeframe: Week 1 up to Week 24

Population: Safety population included all participants who received at least 1 dose of study treatment.

Outcome measures

Outcome measures
Measure	Epoetin Hospira n=301 Participants Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28.	Epogen n=304 Participants Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28.
Percentage of Participants With Any Transient Change of Hemoglobin Greater Than (>) 2.0 Gram Per Deciliter (g/dL) in Hemoglobin Level	13.1 percentage of participants 156128.97	14.5 percentage of participants 141911.73

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 1 up to Week 24

Population: Safety population included all participants who received at least 1 dose of study treatment.

Outcome measures

Outcome measures
Measure	Epoetin Hospira n=301 Participants Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28.	Epogen n=304 Participants Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28.
Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL)	5.3 percentage of participants 156128.97	10.9 percentage of participants 141911.73

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 1 up to Week 24

Population: Safety population included all participants who received at least 1 dose of study treatment.

Outcome measures

Outcome measures
Measure	Epoetin Hospira n=301 Participants Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28.	Epogen n=304 Participants Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28.
Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL)	21.6 percentage of participants 156128.97	23.0 percentage of participants 141911.73

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 1 up to Week 28

Population: Safety population included all participants who received at least 1 dose of study treatment.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged in-patient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events from first dose of study drug to the end of study (up to Week 28) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.

Outcome measures

Outcome measures
Measure	Epoetin Hospira n=301 Participants Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28.	Epogen n=304 Participants Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	232 Participants 156128.97	229 Participants 141911.73
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	75 Participants	82 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 1 up to Week 28

Population: Safety population included all participants who received at least 1 dose of study treatment. Here, "N" signifies those participants who were evaluable for this outcome measure.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug to the end of study (up to Week 28) that were absent before treatment or that worsened relative to pre-treatment state. An AE was assessed according to severity; mild (AE was transient and easily tolerated by the participant), moderate (caused problem that did not interfere significantly with usual activities) and severe (caused problem that interferes significantly with usual activities and might be incapacitating or life-threatening).

Outcome measures

Outcome measures
Measure	Epoetin Hospira n=232 Participants Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28.	Epogen n=229 Participants Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28.
Number of Participants With Treatment-Emergent Adverse Events by Severity Mild	116 Participants 156128.97	111 Participants 141911.73
Number of Participants With Treatment-Emergent Adverse Events by Severity Moderate	74 Participants	69 Participants
Number of Participants With Treatment-Emergent Adverse Events by Severity Severe	42 Participants	49 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 1 up to Week 28

Population: Safety population included all participants who received at least 1 dose of study treatment. Here, "N" signifies those participants who were evaluable for this outcome measure.

An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.

Outcome measures

Outcome measures
Measure	Epoetin Hospira n=232 Participants Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28.	Epogen n=229 Participants Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28.
Number of Participants With Treatment Related Adverse Events (AEs)	7 Participants 156128.97	7 Participants 141911.73

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 1 up to Week 28

Population: Safety population included all participants who received at least 1 dose of study treatment. Here, "N" signifies those participants who were evaluable for this outcome measure.

In this outcome measure number of participants who discontinued from study drug (Epoetin Hospira, Epogen) due to any AE were reported.

Outcome measures

Outcome measures
Measure	Epoetin Hospira n=232 Participants Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28.	Epogen n=229 Participants Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28.
Number of Participants That Discontinued Treatment Due to a Treatment Emergent Adverse Event	9 Participants 156128.97	11 Participants 141911.73

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to Week 28

Population: Safety population included all participants who received at least 1 dose of study treatment.

Laboratory parameters: Hematology (hematocrit, hemoglobin, red blood cell count, reticulocytes, white blood cell count, neutrophils, bands, lymphocytes, monocytes, basophils, eosinophils, platelet count, mean corpuscular volume); coagulation panel (prothrombin time, international normalized ratio, activated partial thromboplastin time); clinical chemistry (blood urea nitrogen, creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, gamma-glutamyl transpeptidase, alkaline phosphatase, sodium, potassium, calcium, magnesium, phosphorus, uric acid, total protein, glucose, albumin, C-reactive protein, plasma ferritin, transferrin saturation). Participants with clinically significant change from baseline in laboratory parameters were as determined by the investigator.

Outcome measures

Outcome measures
Measure	Epoetin Hospira n=301 Participants Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28.	Epogen n=304 Participants Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28.
Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters	0 Participants 156128.97	0 Participants 141911.73

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to Week 28

Population: Safety population included all participants who received at least 1 dose of study treatment.

Vital sign parameters: temperature (oral, tympanic, or other), blood pressure (diastolic and systolic), heart rate (in a seated position) and dry weight (post-dialysis). Participants with clinically significant change from baseline in vital signs were as determined by the investigator.

Outcome measures

Outcome measures
Measure	Epoetin Hospira n=301 Participants Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28.	Epogen n=304 Participants Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28.
Number of Participants With Clinically Significant Change From Baseline in Vital Signs	0 Participants 156128.97	0 Participants 141911.73

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to Week 28

Population: Safety population included all participants who received at least 1 dose of study treatment.

ECG parameters: PR interval, QRS complex, QT interval and QTC interval. Participants with clinically significant change from baseline in ECG were as determined by the investigator.

Outcome measures

Outcome measures
Measure	Epoetin Hospira n=301 Participants Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28.	Epogen n=304 Participants Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28.
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)	0 Participants 156128.97	0 Participants 141911.73

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to Week 28

Population: Safety population included all participants who received at least 1 dose of study treatment.

Physical examination included examination of the following: skin, eyes, ears, throat, cardiac, respiratory, gastrointestinal, genitourinary and musculoskeletal systems. Participants with clinically significant change from baseline in physical examination were as determined by the investigator.

Outcome measures

Outcome measures
Measure	Epoetin Hospira n=301 Participants Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28.	Epogen n=304 Participants Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28.
Number of Participants With Clinically Significant Change From Baseline in Physical Examination	0 Participants 156128.97	0 Participants 141911.73

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 1 up to Week 28

Population: Safety population included all participants who received at least 1 dose of study treatment.

Percentage of participants with presence of anti-rhEPO antibodies were reported in this outcome measure. Radioimmunoprecipitation assay method was used to determine the presence of anti-rhEPO antibodies.

Outcome measures

Outcome measures
Measure	Epoetin Hospira n=301 Participants Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28.	Epogen n=304 Participants Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28.
Percentage of Participants With Anti-Recombinant Human Erythropoietin (Anti-rhEPO) Antibodies	0.4 percentage of participants 156128.97	0.0 percentage of participants 141911.73

Adverse Events

Epoetin Hospira

Serious events: 75 serious events

Other events: 143 other events

Deaths: 0 deaths

Epogen

Serious events: 82 serious events

Other events: 141 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Epoetin Hospira n=301 participants at risk Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28.	Epogen n=304 participants at risk Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28.
Gastrointestinal disorders Diarrhoea	7.0% 21/301 Same event may appear as both AE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study. Safety population.	8.9% 27/304 Same event may appear as both AE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study. Safety population.
Gastrointestinal disorders Nausea	10.0% 30/301 Same event may appear as both AE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study. Safety population.	8.2% 25/304 Same event may appear as both AE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study. Safety population.
Gastrointestinal disorders Vomiting	9.3% 28/301 Same event may appear as both AE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study. Safety population.	4.9% 15/304 Same event may appear as both AE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study. Safety population.
Injury, poisoning and procedural complications Arteriovenous fistula site complication	8.3% 25/301 Same event may appear as both AE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study. Safety population.	7.6% 23/304 Same event may appear as both AE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study. Safety population.
Musculoskeletal and connective tissue disorders Back pain	4.0% 12/301 Same event may appear as both AE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study. Safety population.	5.3% 16/304 Same event may appear as both AE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study. Safety population.
Musculoskeletal and connective tissue disorders Muscle spasms	9.0% 27/301 Same event may appear as both AE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study. Safety population.	7.9% 24/304 Same event may appear as both AE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study. Safety population.
Musculoskeletal and connective tissue disorders Pain in extremity	3.3% 10/301 Same event may appear as both AE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study. Safety population.	5.6% 17/304 Same event may appear as both AE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study. Safety population.
Nervous system disorders Dizziness	6.3% 19/301 Same event may appear as both AE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study. Safety population.	4.6% 14/304 Same event may appear as both AE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study. Safety population.
Nervous system disorders Headache	7.6% 23/301 Same event may appear as both AE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study. Safety population.	5.3% 16/304 Same event may appear as both AE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study. Safety population.
Respiratory, thoracic and mediastinal disorders Cough	5.3% 16/301 Same event may appear as both AE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study. Safety population.	7.2% 22/304 Same event may appear as both AE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study. Safety population.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.3% 19/301 Same event may appear as both AE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study. Safety population.	4.9% 15/304 Same event may appear as both AE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study. Safety population.
Vascular disorders Hypertension	5.6% 17/301 Same event may appear as both AE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study. Safety population.	3.6% 11/304 Same event may appear as both AE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study. Safety population.
Vascular disorders Hypotension	4.3% 13/301 Same event may appear as both AE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study. Safety population.	7.2% 22/304 Same event may appear as both AE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study. Safety population.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER