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Trial record 1 of 1 for:    EPOE-10-01
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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 (AiME - 01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01473407
Recruitment Status : Completed
First Posted : November 17, 2011
Results First Posted : July 13, 2018
Last Update Posted : September 10, 2018
Sponsor:
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Chronic Kidney Disease
Chronic Renal Failure
Interventions Biological: Epoetin Hospira
Biological: Epogen (Amgen)
Enrollment 612
Recruitment Details Participants with chronic renal failure were receiving Epoetin maintenance therapy prior to enrollment and treatment in this study.
Pre-assignment Details  
Arm/Group Title Epoetin Hospira Epogen
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 306 306
Completed 252 259
Not Completed 54 47
Reason Not Completed
Physician Decision             1             4
Lost to Follow-up             10             4
Adverse Event             8             8
Randomization Error             3             1
Withdrawal by Subject             4             7
Kidney Transplant             7             6
Vacation/Travel             1             1
Elevated Hemoglobin             1             0
Patient Received Aranesp             1             0
Patient Lost Green Card Status             1             0
Temperature Excursion             2             3
Transfer to Another Facility/Unit             4             3
Sponsor's Decision             10             10
Site Closure             1             0
Arm/Group Title Epoetin Hospira Epogen Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 306 306 612
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population included all participants who were randomized to study treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 306 participants 306 participants 612 participants
55.32  (13.057) 57.35  (11.440) 56.34  (12.307)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 306 participants 306 participants 612 participants
Female
146
  47.7%
131
  42.8%
277
  45.3%
Male
160
  52.3%
175
  57.2%
335
  54.7%
1.Primary Outcome
Title Mean Weekly Hemoglobin Level From Week 21 to Week 24
Hide Description [Not Specified]
Time Frame Week 21 up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to study treatment.
Arm/Group Title Epoetin Hospira Epogen
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 306 306
Mean (Standard Deviation)
Unit of Measure: g/dL
10.17  (0.847) 10.28  (0.839)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epoetin Hospira, Epogen
Comments Least Square (LS) mean and 95 percent confidence interval (CI) were derived from an ANCOVA model with fixed effect of treatment.
Type of Statistical Test Non-Inferiority or Equivalence
Comments An equivalence margin of +/- 0.5 was considered relevant to demonstrate the equivalence of the two products.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.12
Confidence Interval (2-Sided) 95%
-0.25 to 0.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.066
Estimation Comments [Not Specified]
2.Primary Outcome
Title Mean Weekly Dosage of Study Medication From Week 21 to Week 24
Hide Description [Not Specified]
Time Frame Week 21 up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Epoetin Hospira Epogen
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 305 305
Mean (Standard Deviation)
Unit of Measure: unit per kilogram per week (U/kg/week)
89.61  (99.824) 90.37  (88.492)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epoetin Hospira, Epogen
Comments LS mean and 95 percent CI were derived from an ANCOVA model with fixed effect of treatment.
Type of Statistical Test Non-Inferiority or Equivalence
Comments An equivalence margin of +/- 0.5 was considered relevant to demonstrate the equivalence of the two products.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.37
Confidence Interval (2-Sided) 95%
-10.40 to 11.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.483
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Mean Weekly Hemoglobin Level Through 24 Weeks
Hide Description [Not Specified]
Time Frame Week 1 up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to study treatment. Here, "N" signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title Epoetin Hospira Epogen
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 302 305
Mean (Standard Deviation)
Unit of Measure: g/dL
10.25  (0.591) 10.26  (0.597)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epoetin Hospira, Epogen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7563
Comments P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.
Method Wilcoxon Rank Sum test
Comments [Not Specified]
4.Secondary Outcome
Title Mean Weekly Dosage of Study Medication Through 24 Weeks
Hide Description [Not Specified]
Time Frame Week 1 up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to study treatment. Here, "N" signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title Epoetin Hospira Epogen
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 301 305
Mean (Standard Deviation)
Unit of Measure: U/kg/week
87.51  (86.405) 90.95  (80.619)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epoetin Hospira, Epogen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1061
Comments P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.
Method Wilcoxon Rank Sum test
Comments [Not Specified]
5.Secondary Outcome
Title Total Dose of Study Medication Administered
Hide Description [Not Specified]
Time Frame Week 1 up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to study treatment. Here, "N" signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title Epoetin Hospira Epogen
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 301 305
Mean (Standard Deviation)
Unit of Measure: units of study medication
146752.6  (156128.97) 147145.2  (141911.73)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epoetin Hospira, Epogen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3369
Comments P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.
Method Wilcoxon Rank Sum test
Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With Mean Weekly Hemoglobin Level Within the Target Range
Hide Description Percentage of participants who had hemoglobin level within the target range of 9 to 11 g/dL for the specified weeks were reported.
Time Frame Week 12, 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to study treatment.
Arm/Group Title Epoetin Hospira Epogen
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 306 306
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 81.0 73.2
Week 24 73.2 71.4
7.Secondary Outcome
Title Percentage of Participants Who Required Permanent Dose Changes of Study Medication
Hide Description [Not Specified]
Time Frame Week 1 up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population was a subset of ITT participants who did not have major protocol violations.
Arm/Group Title Epoetin Hospira Epogen
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 204 192
Measure Type: Number
Unit of Measure: percentage of participants
86.3 93.2
8.Secondary Outcome
Title Percentage of Participants Who Required Temporary Dose Changes of Study Medication
Hide Description [Not Specified]
Time Frame Week 1 up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population was a subset of ITT participants who did not have major protocol violations.
Arm/Group Title Epoetin Hospira Epogen
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 204 192
Measure Type: Number
Unit of Measure: percentage of participants
7.4 4.2
9.Secondary Outcome
Title Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 1 Gram Per Deciliter (g/dL)
Hide Description [Not Specified]
Time Frame Week 1 up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population was a subset of ITT participants who did not have major protocol violations.
Arm/Group Title Epoetin Hospira Epogen
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 204 192
Measure Type: Number
Unit of Measure: percentage of participants
44.1 43.2
10.Secondary Outcome
Title Percentage of Participants With Mean Weekly Hemoglobin Level Outside the Target Range
Hide Description Percentage of participants who had hemoglobin level outside the target range of 9 to 11 g/dL for the specified weeks were reported.
Time Frame Week 12, 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to study treatment.
Arm/Group Title Epoetin Hospira Epogen
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 306 306
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 19.0 26.8
Week 24 26.8 28.6
11.Secondary Outcome
Title Percentage of Participants Who Received Blood Transfusions
Hide Description [Not Specified]
Time Frame Week 1 up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to study treatment. Here, "N" signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title Epoetin Hospira Epogen
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 303 305
Measure Type: Number
Unit of Measure: percentage of participants
6.3 5.9
12.Secondary Outcome
Title Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level
Hide Description 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
Time Frame Week 1 up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to study treatment. Here, "N" signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title Epoetin Hospira Epogen
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 301 305
Measure Type: Count of Participants
Unit of Measure: Participants
Dose Decrease: Hb <9.0 g/dL
49
  16.3%
37
  12.1%
Dose Decrease: Hb (9 to 11 g/dL)
49
  16.3%
46
  15.1%
Dose Decrease: Hb >11.0 g/dL
147
  48.8%
150
  49.2%
Dose Increase: Hb <9.0 g/dL
50
  16.6%
67
  22.0%
Dose Increase: Hb (9 to 11 g/dL)
27
   9.0%
26
   8.5%
Dose Increase: Hb >11.0 g/dL
36
  12.0%
54
  17.7%
13.Secondary Outcome
Title Percentage of Participants With Any Transient Change of Hemoglobin Greater Than (>) 2.0 Gram Per Deciliter (g/dL) in Hemoglobin Level
Hide Description [Not Specified]
Time Frame Week 1 up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study treatment.
Arm/Group Title Epoetin Hospira Epogen
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 301 304
Measure Type: Number
Unit of Measure: percentage of participants
13.1 14.5
14.Other Pre-specified Outcome
Title Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL)
Hide Description [Not Specified]
Time Frame Week 1 up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study treatment.
Arm/Group Title Epoetin Hospira Epogen
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 301 304
Measure Type: Number
Unit of Measure: percentage of participants
5.3 10.9
15.Other Pre-specified Outcome
Title Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL)
Hide Description [Not Specified]
Time Frame Week 1 up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study treatment.
Arm/Group Title Epoetin Hospira Epogen
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 301 304
Measure Type: Number
Unit of Measure: percentage of participants
21.6 23.0
16.Other Pre-specified Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame Week 1 up to Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study treatment.
Arm/Group Title Epoetin Hospira Epogen
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 301 304
Measure Type: Count of Participants
Unit of Measure: Participants
AEs
232
  77.1%
229
  75.3%
SAEs
75
  24.9%
82
  27.0%
17.Other Pre-specified Outcome
Title Number of Participants With Treatment-Emergent Adverse Events by Severity
Hide Description 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).
Time Frame Week 1 up to Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Epoetin Hospira Epogen
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 232 229
Measure Type: Count of Participants
Unit of Measure: Participants
Mild
116
  50.0%
111
  48.5%
Moderate
74
  31.9%
69
  30.1%
Severe
42
  18.1%
49
  21.4%
18.Other Pre-specified Outcome
Title Number of Participants With Treatment Related Adverse Events (AEs)
Hide Description An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.
Time Frame Week 1 up to Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Epoetin Hospira Epogen
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 232 229
Measure Type: Count of Participants
Unit of Measure: Participants
7
   3.0%
7
   3.1%
19.Other Pre-specified Outcome
Title Number of Participants That Discontinued Treatment Due to a Treatment Emergent Adverse Event
Hide Description In this outcome measure number of participants who discontinued from study drug (Epoetin Hospira, Epogen) due to any AE were reported.
Time Frame Week 1 up to Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Epoetin Hospira Epogen
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 232 229
Measure Type: Count of Participants
Unit of Measure: Participants
9
   3.9%
11
   4.8%
20.Other Pre-specified Outcome
Title Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters
Hide Description 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.
Time Frame Baseline up to Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study treatment.
Arm/Group Title Epoetin Hospira Epogen
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 301 304
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
21.Other Pre-specified Outcome
Title Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Hide Description 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.
Time Frame Baseline up to Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study treatment.
Arm/Group Title Epoetin Hospira Epogen
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 301 304
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
22.Other Pre-specified Outcome
Title Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)
Hide Description 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.
Time Frame Baseline up to Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study treatment.
Arm/Group Title Epoetin Hospira Epogen
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 301 304
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
23.Other Pre-specified Outcome
Title Number of Participants With Clinically Significant Change From Baseline in Physical Examination
Hide Description 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.
Time Frame Baseline up to Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study treatment.
Arm/Group Title Epoetin Hospira Epogen
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 301 304
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
24.Other Pre-specified Outcome
Title Percentage of Participants With Anti-Recombinant Human Erythropoietin (Anti-rhEPO) Antibodies
Hide Description 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.
Time Frame Week 1 up to Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study treatment.
Arm/Group Title Epoetin Hospira Epogen
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 301 304
Measure Type: Number
Unit of Measure: percentage of participants
0.4 0.0
Time Frame [Not Specified]
Adverse Event Reporting Description 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.
 
Arm/Group Title Epoetin Hospira Epogen
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Epoetin Hospira Epogen
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Epoetin Hospira Epogen
Affected / at Risk (%) Affected / at Risk (%)
Total   75/301 (24.92%)   82/304 (26.97%) 
Blood and lymphatic system disorders     
Anaemia * 1  1/301 (0.33%)  2/304 (0.66%) 
Lymphadenitis * 1  1/301 (0.33%)  0/304 (0.00%) 
Microcytic anaemia * 1  1/301 (0.33%)  0/304 (0.00%) 
Cardiac disorders     
Acute myocardial infarction * 1  2/301 (0.66%)  2/304 (0.66%) 
Angina pectoris * 1  1/301 (0.33%)  4/304 (1.32%) 
Atrial fibrillation * 1  2/301 (0.66%)  1/304 (0.33%) 
Bradycardia * 1  3/301 (1.00%)  1/304 (0.33%) 
Cardiac arrest * 1  0/301 (0.00%)  3/304 (0.99%) 
Cardiac failure * 1  0/301 (0.00%)  1/304 (0.33%) 
Cardiac failure congestive * 1  4/301 (1.33%)  3/304 (0.99%) 
Cardio-respiratory arrest * 1  0/301 (0.00%)  2/304 (0.66%) 
Coronary artery disease * 1  2/301 (0.66%)  1/304 (0.33%) 
Coronary artery stenosis * 1  0/301 (0.00%)  1/304 (0.33%) 
Pericardial effusion * 1  1/301 (0.33%)  0/304 (0.00%) 
Pulseless electrical activity * 1  0/301 (0.00%)  1/304 (0.33%) 
Tachycardia * 1  2/301 (0.66%)  0/304 (0.00%) 
Congenital, familial and genetic disorders     
Congenital cystic kidney disease * 1  1/301 (0.33%)  0/304 (0.00%) 
Gastrointestinal arteriovenous malformation * 1  0/301 (0.00%)  1/304 (0.33%) 
Eye disorders     
Diabetic retinopathy * 1  0/301 (0.00%)  1/304 (0.33%) 
Gastrointestinal disorders     
Ascites * 1  1/301 (0.33%)  0/304 (0.00%) 
Colitis ischaemic * 1  1/301 (0.33%)  0/304 (0.00%) 
Colonic polyp * 1  0/301 (0.00%)  1/304 (0.33%) 
Diverticulum intestinal haemorrhagic * 1  1/301 (0.33%)  0/304 (0.00%) 
Faecaloma * 1  0/301 (0.00%)  1/304 (0.33%) 
Gastritis * 1  0/301 (0.00%)  2/304 (0.66%) 
Gastrointestinal disorder * 1  0/301 (0.00%)  1/304 (0.33%) 
Gastrointestinal haemorrhage * 1  1/301 (0.33%)  2/304 (0.66%) 
Gastrooesophageal reflux disease * 1  1/301 (0.33%)  0/304 (0.00%) 
Ileus * 1  1/301 (0.33%)  0/304 (0.00%) 
Lower gastrointestinal haemorrhage * 1  1/301 (0.33%)  0/304 (0.00%) 
Pancreatitis * 1  0/301 (0.00%)  1/304 (0.33%) 
Retroperitoneal haemorrhage * 1  0/301 (0.00%)  1/304 (0.33%) 
Small intestinal obstruction * 1  1/301 (0.33%)  1/304 (0.33%) 
General disorders     
Chest pain * 1  2/301 (0.66%)  0/304 (0.00%) 
Device malfunction * 1  1/301 (0.33%)  0/304 (0.00%) 
Medical device complication * 1  0/301 (0.00%)  1/304 (0.33%) 
Non-cardiac chest pain * 1  2/301 (0.66%)  7/304 (2.30%) 
Pain * 1  1/301 (0.33%)  0/304 (0.00%) 
Pelvic mass * 1  1/301 (0.33%)  0/304 (0.00%) 
Pyrexia * 1  0/301 (0.00%)  2/304 (0.66%) 
Sudden death * 1  1/301 (0.33%)  0/304 (0.00%) 
Hepatobiliary disorders     
Cholecystitis * 1  1/301 (0.33%)  0/304 (0.00%) 
Cholecystitis acute * 1  0/301 (0.00%)  1/304 (0.33%) 
Cholelithiasis * 1  1/301 (0.33%)  1/304 (0.33%) 
Hepatic cirrhosis * 1  1/301 (0.33%)  0/304 (0.00%) 
Infections and infestations     
Abscess limb * 1  0/301 (0.00%)  1/304 (0.33%) 
Anal abscess * 1  1/301 (0.33%)  0/304 (0.00%) 
Appendicitis * 1  0/301 (0.00%)  1/304 (0.33%) 
Arteriovenous graft site infection * 1  0/301 (0.00%)  1/304 (0.33%) 
Bacteraemia * 1  1/301 (0.33%)  0/304 (0.00%) 
Bronchitis * 1  1/301 (0.33%)  0/304 (0.00%) 
Bursitis infective * 1  1/301 (0.33%)  0/304 (0.00%) 
Cellulitis * 1  0/301 (0.00%)  6/304 (1.97%) 
Chest wall abscess * 1  0/301 (0.00%)  1/304 (0.33%) 
Cytomegalovirus colitis * 1  0/301 (0.00%)  1/304 (0.33%) 
Cytomegalovirus viraemia * 1  0/301 (0.00%)  1/304 (0.33%) 
Device related infection * 1  1/301 (0.33%)  2/304 (0.66%) 
Device related sepsis * 1  0/301 (0.00%)  1/304 (0.33%) 
Diverticulitis * 1  1/301 (0.33%)  0/304 (0.00%) 
Endocarditis * 1  0/301 (0.00%)  1/304 (0.33%) 
Gangrene * 1  0/301 (0.00%)  3/304 (0.99%) 
Gastroenteritis * 1  1/301 (0.33%)  1/304 (0.33%) 
Graft infection * 1  0/301 (0.00%)  1/304 (0.33%) 
Lobar pneumonia * 1  2/301 (0.66%)  0/304 (0.00%) 
Osteomyelitis * 1  3/301 (1.00%)  1/304 (0.33%) 
Pneumonia * 1  4/301 (1.33%)  8/304 (2.63%) 
Pneumonia staphylococcal * 1  0/301 (0.00%)  1/304 (0.33%) 
Sepsis * 1  3/301 (1.00%)  3/304 (0.99%) 
Staphylococcal bacteraemia * 1  1/301 (0.33%)  1/304 (0.33%) 
Staphylococcal infection * 1  0/301 (0.00%)  1/304 (0.33%) 
Subcutaneous abscess * 1  0/301 (0.00%)  1/304 (0.33%) 
Urinary tract infection * 1  2/301 (0.66%)  1/304 (0.33%) 
West Nile viral infection * 1  0/301 (0.00%)  1/304 (0.33%) 
Wound infection * 1  0/301 (0.00%)  1/304 (0.33%) 
Abdominal abscess * 1  0/301 (0.00%)  2/304 (0.66%) 
Injury, poisoning and procedural complications     
Arteriovenous fistula site complication * 1  2/301 (0.66%)  2/304 (0.66%) 
Arteriovenous fistula site haemorrhage * 1  1/301 (0.33%)  1/304 (0.33%) 
Arteriovenous fistula thrombosis * 1  3/301 (1.00%)  2/304 (0.66%) 
Clavicle fracture * 1  1/301 (0.33%)  0/304 (0.00%) 
Femur fracture * 1  0/301 (0.00%)  2/304 (0.66%) 
Graft thrombosis * 1  0/301 (0.00%)  1/304 (0.33%) 
Hip fracture * 1  0/301 (0.00%)  1/304 (0.33%) 
Lower limb fracture * 1  2/301 (0.66%)  0/304 (0.00%) 
Postoperative fever * 1  1/301 (0.33%)  0/304 (0.00%) 
Radius fracture * 1  1/301 (0.33%)  0/304 (0.00%) 
Rib fracture * 1  1/301 (0.33%)  0/304 (0.00%) 
Spinal compression fracture * 1  0/301 (0.00%)  1/304 (0.33%) 
Spinal fracture * 1  1/301 (0.33%)  0/304 (0.00%) 
Transplant failure * 1  0/301 (0.00%)  1/304 (0.33%) 
Vascular graft complication * 1  1/301 (0.33%)  0/304 (0.00%) 
Vascular graft thrombosis * 1  1/301 (0.33%)  0/304 (0.00%) 
Vascular pseudoaneurysm * 1  1/301 (0.33%)  0/304 (0.00%) 
Metabolism and nutrition disorders     
Diabetic foot * 1  0/301 (0.00%)  2/304 (0.66%) 
Diabetic ketoacidosis * 1  1/301 (0.33%)  0/304 (0.00%) 
Electrolyte imbalance * 1  1/301 (0.33%)  0/304 (0.00%) 
Fluid overload * 1  1/301 (0.33%)  6/304 (1.97%) 
Hyperglycaemia * 1  0/301 (0.00%)  1/304 (0.33%) 
Hyperkalaemia * 1  2/301 (0.66%)  4/304 (1.32%) 
Hypocalcaemia * 1  0/301 (0.00%)  1/304 (0.33%) 
Hypoglycaemia * 1  2/301 (0.66%)  0/304 (0.00%) 
Hyponatraemia * 1  0/301 (0.00%)  1/304 (0.33%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/301 (0.33%)  0/304 (0.00%) 
Back pain * 1  1/301 (0.33%)  0/304 (0.00%) 
Cervical spinal stenosis * 1  0/301 (0.00%)  1/304 (0.33%) 
Haemarthrosis * 1  0/301 (0.00%)  1/304 (0.33%) 
Intervertebral disc protrusion * 1  1/301 (0.33%)  0/304 (0.00%) 
Myositis * 1  0/301 (0.00%)  1/304 (0.33%) 
Osteoarthritis * 1  1/301 (0.33%)  0/304 (0.00%) 
Osteonecrosis * 1  1/301 (0.33%)  0/304 (0.00%) 
Tendonitis * 1  1/301 (0.33%)  0/304 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bile duct cancer * 1  1/301 (0.33%)  0/304 (0.00%) 
Colon cancer stage III * 1  0/301 (0.00%)  1/304 (0.33%) 
Lung cancer metastatic * 1  0/301 (0.00%)  1/304 (0.33%) 
Non-small cell lung cancer * 1  0/301 (0.00%)  1/304 (0.33%) 
Plasmacytoma * 1  1/301 (0.33%)  0/304 (0.00%) 
Prostate cancer * 1 [1]  0/160 (0.00%)  1/175 (0.57%) 
Nervous system disorders     
Basal ganglia haemorrhage * 1  1/301 (0.33%)  0/304 (0.00%) 
Carotid artery stenosis * 1  1/301 (0.33%)  0/304 (0.00%) 
Cerebrovascular accident * 1  1/301 (0.33%)  1/304 (0.33%) 
Cervical myelopathy * 1  0/301 (0.00%)  1/304 (0.33%) 
Convulsion * 1  0/301 (0.00%)  1/304 (0.33%) 
Dizziness * 1  1/301 (0.33%)  1/304 (0.33%) 
Encephalopathy * 1  0/301 (0.00%)  1/304 (0.33%) 
Hepatic encephalopathy * 1  1/301 (0.33%)  0/304 (0.00%) 
IIIrd nerve paralysis * 1  0/301 (0.00%)  1/304 (0.33%) 
Metabolic encephalopathy * 1  1/301 (0.33%)  1/304 (0.33%) 
Syncope * 1  2/301 (0.66%)  1/304 (0.33%) 
Transient ischaemic attack * 1  0/301 (0.00%)  1/304 (0.33%) 
Psychiatric disorders     
Suicidal ideation * 1  0/301 (0.00%)  1/304 (0.33%) 
Renal and urinary disorders     
Azotaemia * 1  2/301 (0.66%)  0/304 (0.00%) 
Renal cyst ruptured * 1  1/301 (0.33%)  0/304 (0.00%) 
Renal failure chronic * 1  0/301 (0.00%)  1/304 (0.33%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure * 1  4/301 (1.33%)  0/304 (0.00%) 
Bronchiectasis * 1  1/301 (0.33%)  0/304 (0.00%) 
Chronic obstructive pulmonary disease * 1  3/301 (1.00%)  0/304 (0.00%) 
Dyspnoea * 1  3/301 (1.00%)  8/304 (2.63%) 
Haemothorax * 1  1/301 (0.33%)  0/304 (0.00%) 
Hypoxia * 1  0/301 (0.00%)  2/304 (0.66%) 
Non-cardiogenic pulmonary oedema * 1  1/301 (0.33%)  0/304 (0.00%) 
Pleural effusion * 1  2/301 (0.66%)  0/304 (0.00%) 
Pneumonia aspiration * 1  0/301 (0.00%)  1/304 (0.33%) 
Pneumonitis * 1  1/301 (0.33%)  0/304 (0.00%) 
Pulmonary embolism * 1  0/301 (0.00%)  1/304 (0.33%) 
Pulmonary oedema * 1  2/301 (0.66%)  0/304 (0.00%) 
Respiratory arrest * 1  1/301 (0.33%)  0/304 (0.00%) 
Respiratory disorder * 1  1/301 (0.33%)  0/304 (0.00%) 
Respiratory distress * 1  0/301 (0.00%)  1/304 (0.33%) 
Respiratory failure * 1  0/301 (0.00%)  2/304 (0.66%) 
Skin and subcutaneous tissue disorders     
Angioedema * 1  0/301 (0.00%)  1/304 (0.33%) 
Vascular disorders     
Aortic aneurysm * 1  1/301 (0.33%)  0/304 (0.00%) 
Deep vein thrombosis * 1  1/301 (0.33%)  0/304 (0.00%) 
Haematoma * 1  0/301 (0.00%)  1/304 (0.33%) 
Hypertension * 1  2/301 (0.66%)  2/304 (0.66%) 
Hypertensive crisis * 1  1/301 (0.33%)  2/304 (0.66%) 
Hypotension * 1  1/301 (0.33%)  1/304 (0.33%) 
Orthostatic hypotension * 1  0/301 (0.00%)  1/304 (0.33%) 
Peripheral ischaemia * 1  1/301 (0.33%)  1/304 (0.33%) 
Peripheral vascular disorder * 1  1/301 (0.33%)  0/304 (0.00%) 
Steal syndrome * 1  0/301 (0.00%)  2/304 (0.66%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
[1]
This event was gender specific.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Epoetin Hospira Epogen
Affected / at Risk (%) Affected / at Risk (%)
Total   143/301 (47.51%)   141/304 (46.38%) 
Gastrointestinal disorders     
Diarrhoea * 1  21/301 (6.98%)  27/304 (8.88%) 
Nausea * 1  30/301 (9.97%)  25/304 (8.22%) 
Vomiting * 1  28/301 (9.30%)  15/304 (4.93%) 
Injury, poisoning and procedural complications     
Arteriovenous fistula site complication * 1  25/301 (8.31%)  23/304 (7.57%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  12/301 (3.99%)  16/304 (5.26%) 
Muscle spasms * 1  27/301 (8.97%)  24/304 (7.89%) 
Pain in extremity * 1  10/301 (3.32%)  17/304 (5.59%) 
Nervous system disorders     
Dizziness * 1  19/301 (6.31%)  14/304 (4.61%) 
Headache * 1  23/301 (7.64%)  16/304 (5.26%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  16/301 (5.32%)  22/304 (7.24%) 
Dyspnoea * 1  19/301 (6.31%)  15/304 (4.93%) 
Vascular disorders     
Hypertension * 1  17/301 (5.65%)  11/304 (3.62%) 
Hypotension * 1  13/301 (4.32%)  22/304 (7.24%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01473407    
Other Study ID Numbers: EPOE-10-01
C3461001 ( Other Identifier: Alias Study Number )
First Submitted: November 2, 2011
First Posted: November 17, 2011
Results First Submitted: May 21, 2018
Results First Posted: July 13, 2018
Last Update Posted: September 10, 2018