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A Phase 3 Study Comparing the Effects of Subcutaneous 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 - 13)

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: NCT01473420
Recruitment Status : Completed
First Posted : November 17, 2011
Results First Posted : June 20, 2018
Last Update Posted : August 9, 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 Renal Failure
Chronic Kidney Disease
Interventions Biological: Epoetin Hospira
Biological: Epogen Amgen
Enrollment 320
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 During titration period participants who were on Epogen intravenous (IV) regimen prior to this study, were titrated and optimally stabilized to receive subcutaneous (SC) injection of Epoetin Hospira. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose of study treatment was adjusted to maintain hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18). During maintenance period participants received SC injection of Epoetin Hospira at optimal dose demonstrated in titration period 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38). During titration period participants who were on Epogen IV regimen prior to enrollment in this study, were titrated and optimally stabilized to receive SC injection of Epogen. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18). During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
Period Title: Titration Period (18 Weeks)
Started 160 160
Treated 80 86
Completed 124 122
Not Completed 36 38
Reason Not Completed
Adverse Event             4             6
Did not meet criteria             32             32
Period Title: Maintenance Period (16 Weeks)
Started 124 122
Completed 106 105
Not Completed 18 17
Reason Not Completed
Adverse Event             3             2
Physician Decision             1             2
Did not meet criteria             0             2
Kidney transplant             3             1
Lost to Follow-up             1             2
Withdrawal by Subject             4             6
Site closure             3             1
Started Peritoneal Dialysis             1             0
Long term hospitalization             0             1
Sponsor's Decision             1             0
Elevated Hemoglobin             1             0
Arm/Group Title Epoetin Hospira Epogen Total
Hide Arm/Group Description During titration period participants who were on Epogen intravenous (IV) regimen prior to this study, were titrated and optimally stabilized to receive subcutaneous (SC) injection of Epoetin Hospira. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose of study treatment was adjusted to maintain hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18). During maintenance period participants received SC injection of Epoetin Hospira at optimal dose demonstrated in titration period 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38). During titration period participants who were on Epogen IV regimen prior to enrollment in this study, were titrated and optimally stabilized to receive SC injection of Epogen. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18). During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38). Total of all reporting groups
Overall Number of Baseline Participants 160 160 320
Hide Baseline Analysis Population Description
Analysis population included all participants who were enrolled.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 160 participants 160 participants 320 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
109
  68.1%
117
  73.1%
226
  70.6%
>=65 years
51
  31.9%
43
  26.9%
94
  29.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 160 participants 160 participants 320 participants
Female
77
  48.1%
84
  52.5%
161
  50.3%
Male
83
  51.9%
76
  47.5%
159
  49.7%
1.Primary Outcome
Title Mean Weekly Hemoglobin Level From Week 30 to Week 34: Maintenance Period
Hide Description [Not Specified]
Time Frame Week 30 up to Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was planned not to be analyzed in titration period. Intent-to-treat (ITT) population included all participants who were randomized into the maintenance period.
Arm/Group Title Epoetin Hospira: Maintenance Period Epogen: Maintenance Period
Hide Arm/Group Description:
During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
Overall Number of Participants Analyzed 124 122
Mean (Standard Deviation)
Unit of Measure: g/dL
10.17  (0.821) 10.11  (0.838)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epoetin Hospira: Maintenance Period, Epogen: Maintenance Period
Comments Least square (LS) mean and 95 percent confidence interval (CI) derived from an analysis of covariance (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 0.04
Confidence Interval (2-Sided) 95%
-0.17 to 0.24
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.104
Estimation Comments [Not Specified]
2.Primary Outcome
Title Mean Weekly Dosage of Study Medication From Week 30 to Week 34: Maintenance Period
Hide Description [Not Specified]
Time Frame Week 30 up to Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period.
Arm/Group Title Epoetin Hospira: Maintenance Period Epogen: Maintenance Period
Hide Arm/Group Description:
During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
Overall Number of Participants Analyzed 124 122
Mean (Standard Deviation)
Unit of Measure: unit per kilogram per week (U/kg/week)
82.07  (95.517) 79.14  (82.264)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epoetin Hospira: Maintenance Period, Epogen: Maintenance Period
Comments LS mean and 95 percent CI 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 -2.34
Confidence Interval (2-Sided) 95%
-14.51 to 9.82
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.175
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Mean Weekly Hemoglobin Level From Week 19 to Week 34: Maintenance Period
Hide Description [Not Specified]
Time Frame Week 19 up to Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period. Here, "Number of Participants Analyzed" (N) signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title Epoetin Hospira: Maintenance Period Epogen: Maintenance Period
Hide Arm/Group Description:
During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
Overall Number of Participants Analyzed 124 121
Mean (Standard Deviation)
Unit of Measure: g/dL
10.20  (0.625) 10.22  (0.665)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epoetin Hospira: Maintenance Period, Epogen: Maintenance Period
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8338
Comments [Not Specified]
Method Two-sample t-test
Comments [Not Specified]
4.Secondary Outcome
Title Mean Weekly Dosage of Study Medication From Week 19 to Week 34: Maintenance Period
Hide Description [Not Specified]
Time Frame Week 19 up to Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period. Here, "N" signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title Epoetin Hospira: Maintenance Period Epogen: Maintenance Period
Hide Arm/Group Description:
During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
Overall Number of Participants Analyzed 123 121
Mean (Standard Deviation)
Unit of Measure: U/kg/week
81.93  (93.824) 75.08  (72.174)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epoetin Hospira: Maintenance Period, Epogen: Maintenance Period
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6895
Comments [Not Specified]
Method Wilcoxon Rank Sum test
Comments P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.
5.Secondary Outcome
Title Total Dose of Study Medication Administered: Maintenance Period
Hide Description In this outcome measure mean of total dose of study medication administered in maintenance period was reported.
Time Frame Week 19 up to Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period. Here, "N" signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title Epoetin Hospira: Maintenance Period Epogen: Maintenance Period
Hide Arm/Group Description:
During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
Overall Number of Participants Analyzed 123 121
Mean (Standard Deviation)
Unit of Measure: units of study medication
102003.2  (135560.52) 86478.5  (83351.03)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epoetin Hospira: Maintenance Period, Epogen: Maintenance Period
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9177
Comments [Not Specified]
Method Wilcoxon Rank Sum test
Comments P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.
6.Secondary Outcome
Title Percentage of Participants With Mean Weekly Hemoglobin Level Within the Target Range: Maintenance Period
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 26, 34
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period.
Arm/Group Title Epoetin Hospira: Maintenance Period Epogen: Maintenance Period
Hide Arm/Group Description:
During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
Overall Number of Participants Analyzed 124 122
Measure Type: Number
Unit of Measure: percentage of participants
Week 26 73.5 60.9
Week 34 79.8 74.0
7.Secondary Outcome
Title Percentage of Participants Who Required Permanent Dose Changes: Maintenance Period
Hide Description [Not Specified]
Time Frame Week 19 up to Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was planned not to be analyzed in titration period. Per protocol population included all participants who were randomized into the maintenance period and who did not have major protocol violations.
Arm/Group Title Epoetin Hospira: Maintenance Period Epogen: Maintenance Period
Hide Arm/Group Description:
During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
Overall Number of Participants Analyzed 86 92
Measure Type: Number
Unit of Measure: percentage of participants
30.2 25.0
8.Secondary Outcome
Title Percentage of Participants Who Required Temporary Dose Changes: Maintenance Period
Hide Description [Not Specified]
Time Frame Week 19 up to Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was planned not to be analyzed in titration period. Per protocol population included all participants who were randomized into the maintenance period and who did not have major protocol violations.
Arm/Group Title Epoetin Hospira: Maintenance Period Epogen: Maintenance Period
Hide Arm/Group Description:
During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
Overall Number of Participants Analyzed 86 92
Measure Type: Number
Unit of Measure: percentage of participants
55.8 62.0
9.Secondary Outcome
Title Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 1.0 Gram Per Deciliter (g/dL): Maintenance Period
Hide Description [Not Specified]
Time Frame Week 19 up to Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was planned not to be analyzed in titration period. Per protocol population included all participants who were randomized into the maintenance period and who did not have major protocol violations.
Arm/Group Title Epoetin Hospira: Maintenance Period Epogen: Maintenance Period
Hide Arm/Group Description:
During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
Overall Number of Participants Analyzed 86 92
Measure Type: Number
Unit of Measure: percentage of participants
29.1 52.2
10.Secondary Outcome
Title Percentage of Participants With Mean Weekly Hemoglobin Level Outside the Target Range: Maintenance Period
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 26, 34
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period.
Arm/Group Title Epoetin Hospira: Maintenance Period Epogen: Maintenance Period
Hide Arm/Group Description:
During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
Overall Number of Participants Analyzed 124 122
Measure Type: Number
Unit of Measure: percentage of participants
Week 26 13.5 19.3
Week 34 10.1 13.0
11.Secondary Outcome
Title Percentage of Participants Who Qualified as Optimally Titrated and Stable: Titration Period
Hide Description [Not Specified]
Time Frame Week 1 up to Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was planned not to be analyzed in maintenance period. Safety analysis population for titration period included all participants who received at least 1 dose of study treatment in titration period.
Arm/Group Title Epoetin Hospira: Titration Period Epogen: Titration Period
Hide Arm/Group Description:
During titration period participants who were on Epogen IV regimen prior to this study, were titrated and optimally stabilized to receive SC injection of Epoetin Hospira. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose of study treatment was adjusted to maintain Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).
During titration period participants who were on Epogen IV regimen prior to enrollment in this study, were titrated and optimally stabilized to receive SC injection of Epogen. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).
Overall Number of Participants Analyzed 80 86
Measure Type: Number
Unit of Measure: percentage of participants
47.5 47.7
12.Secondary Outcome
Title Percentage of Participants Who Received Blood Transfusions: Maintenance Period
Hide Description [Not Specified]
Time Frame Week 19 up to Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period.
Arm/Group Title Epoetin Hospira: Maintenance Period Epogen: Maintenance Period
Hide Arm/Group Description:
During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
Overall Number of Participants Analyzed 124 122
Measure Type: Number
Unit of Measure: percentage of participants
4.0 4.1
13.Secondary Outcome
Title Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level: Maintenance Period
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 19 up to Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period. Here, "N" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Epoetin Hospira: Maintenance Period Epogen: Maintenance Period
Hide Arm/Group Description:
During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
Overall Number of Participants Analyzed 123 121
Measure Type: Count of Participants
Unit of Measure: Participants
Dose Decrease: Hb <9.0 g/dL
9
   7.3%
10
   8.3%
Dose Decrease: Hb (9.0 to 11.0 g/dL)
20
  16.3%
14
  11.6%
Dose Decrease: Hb >11.0 g/dL
35
  28.5%
40
  33.1%
Dose Increase: Hb <9.0 g/dL
24
  19.5%
23
  19.0%
Dose Increase: Hb (9.0 to 11.0 g/dL)
11
   8.9%
3
   2.5%
Dose Increase: Hb >11.0 g/dL
7
   5.7%
13
  10.7%
14.Secondary Outcome
Title Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 2.0 Gram Per Deciliter (g/dL) in Hemoglobin Level: Maintenance Period
Hide Description [Not Specified]
Time Frame Week 19 up to Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was planned not to be analyzed in titration period. Safety analysis population for maintenance period included all participants who received at least 1 dose of study treatment in maintenance period.
Arm/Group Title Epoetin Hospira: Maintenance Period Epogen: Maintenance Period
Hide Arm/Group Description:
During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
Overall Number of Participants Analyzed 122 122
Measure Type: Number
Unit of Measure: percentage of participants
6.6 10.7
15.Other Pre-specified Outcome
Title Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL): Maintenance Period
Hide Description [Not Specified]
Time Frame Week 19 up to Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was planned not to be analyzed in titration period. Safety analysis population for maintenance period included all participants who received at least 1 dose of study treatment in maintenance period.
Arm/Group Title Epoetin Hospira: Maintenance Period Epogen: Maintenance Period
Hide Arm/Group Description:
During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
Overall Number of Participants Analyzed 122 122
Measure Type: Number
Unit of Measure: percentage of participants
4.1 9.0
16.Other Pre-specified Outcome
Title Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL): Maintenance Period
Hide Description [Not Specified]
Time Frame Week 19 up to Week 34
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was planned not to be analyzed in titration period. Safety analysis population for maintenance period included all participants who received at least 1 dose of study treatment in maintenance period.
Arm/Group Title Epoetin Hospira: Maintenance Period Epogen: Maintenance Period
Hide Arm/Group Description:
During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
Overall Number of Participants Analyzed 122 122
Measure Type: Number
Unit of Measure: percentage of participants
9.8 19.7
17.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. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.
Time Frame Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38
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: Titration Period Epogen: Titration Period Epoetin Hospira: Maintenance Period Epogen: Maintenance Period
Hide Arm/Group Description:
During titration period participants who were on Epogen IV regimen prior to this study, were titrated and optimally stabilized to receive SC injection of Epoetin Hospira. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose of study treatment was adjusted to maintain Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).
During titration period participants who were on Epogen IV regimen prior to enrollment in this study, were titrated and optimally stabilized to receive SC injection of Epogen. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).
During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
Overall Number of Participants Analyzed 80 86 122 122
Measure Type: Count of Participants
Unit of Measure: Participants
AEs
45
  56.3%
54
  62.8%
85
  69.7%
86
  70.5%
SAEs
12
  15.0%
22
  25.6%
23
  18.9%
33
  27.0%
18.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. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment 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 Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38
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: Titration Period Epogen: Titration Period Epoetin Hospira: Maintenance Period Epogen: Maintenance Period
Hide Arm/Group Description:
During titration period participants who were on Epogen IV regimen prior to this study, were titrated and optimally stabilized to receive SC injection of Epoetin Hospira. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose of study treatment was adjusted to maintain Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).
During titration period participants who were on Epogen IV regimen prior to enrollment in this study, were titrated and optimally stabilized to receive SC injection of Epogen. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).
During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
Overall Number of Participants Analyzed 45 54 85 86
Measure Type: Count of Participants
Unit of Measure: Participants
Mild
21
  46.7%
23
  42.6%
42
  49.4%
41
  47.7%
Moderate
15
  33.3%
16
  29.6%
24
  28.2%
27
  31.4%
Severe
9
  20.0%
15
  27.8%
19
  22.4%
18
  20.9%
19.Other Pre-specified Outcome
Title Number of Participants With Treatment Related Adverse Events (AEs)
Hide Description An AE was any untoward medical occurrence in a participant who received study drug.
Time Frame Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38
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: Titration Period Epogen: Titration Period Epoetin Hospira: Maintenance Period Epogen: Maintenance Period
Hide Arm/Group Description:
During titration period participants who were on Epogen IV regimen prior to this study, were titrated and optimally stabilized to receive SC injection of Epoetin Hospira. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose of study treatment was adjusted to maintain Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).
During titration period participants who were on Epogen IV regimen prior to enrollment in this study, were titrated and optimally stabilized to receive SC injection of Epogen. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).
During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
Overall Number of Participants Analyzed 45 54 85 86
Measure Type: Count of Participants
Unit of Measure: Participants
1
   2.2%
4
   7.4%
7
   8.2%
11
  12.8%
20.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 discontinued from study drug (Epoetin Hospira, Epogen) due to any AE were reported.
Time Frame Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38
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: Titration Period Epogen: Titration Period Epoetin Hospira: Maintenance Period Epogen: Maintenance Period
Hide Arm/Group Description:
During titration period participants who were on Epogen IV regimen prior to this study, were titrated and optimally stabilized to receive SC injection of Epoetin Hospira. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose of study treatment was adjusted to maintain Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).
During titration period participants who were on Epogen IV regimen prior to enrollment in this study, were titrated and optimally stabilized to receive SC injection of Epogen. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).
During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
Overall Number of Participants Analyzed 45 54 85 86
Measure Type: Count of Participants
Unit of Measure: Participants
4
   8.9%
6
  11.1%
4
   4.7%
4
   4.7%
21.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 Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38
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: Titration Period Epogen: Titration Period Epoetin Hospira: Maintenance Period Epogen: Maintenance Period
Hide Arm/Group Description:
During titration period participants who were on Epogen IV regimen prior to this study, were titrated and optimally stabilized to receive SC injection of Epoetin Hospira. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose of study treatment was adjusted to maintain Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).
During titration period participants who were on Epogen IV regimen prior to enrollment in this study, were titrated and optimally stabilized to receive SC injection of Epogen. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).
During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
Overall Number of Participants Analyzed 80 86 122 122
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
22.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 Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38
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: Titration Period Epogen: Titration Period Epoetin Hospira: Maintenance Period Epogen: Maintenance Period
Hide Arm/Group Description:
During titration period participants who were on Epogen IV regimen prior to this study, were titrated and optimally stabilized to receive SC injection of Epoetin Hospira. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose of study treatment was adjusted to maintain Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).
During titration period participants who were on Epogen IV regimen prior to enrollment in this study, were titrated and optimally stabilized to receive SC injection of Epogen. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).
During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
Overall Number of Participants Analyzed 80 86 122 122
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
23.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 Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38
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: Titration Period Epogen: Titration Period Epoetin Hospira: Maintenance Period Epogen: Maintenance Period
Hide Arm/Group Description:
During titration period participants who were on Epogen IV regimen prior to this study, were titrated and optimally stabilized to receive SC injection of Epoetin Hospira. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose of study treatment was adjusted to maintain Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).
During titration period participants who were on Epogen IV regimen prior to enrollment in this study, were titrated and optimally stabilized to receive SC injection of Epogen. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).
During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
Overall Number of Participants Analyzed 80 86 122 122
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
24.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 Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38
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: Titration Period Epogen: Titration Period Epoetin Hospira: Maintenance Period Epogen: Maintenance Period
Hide Arm/Group Description:
During titration period participants who were on Epogen IV regimen prior to this study, were titrated and optimally stabilized to receive SC injection of Epoetin Hospira. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose of study treatment was adjusted to maintain Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).
During titration period participants who were on Epogen IV regimen prior to enrollment in this study, were titrated and optimally stabilized to receive SC injection of Epogen. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).
During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
Overall Number of Participants Analyzed 80 86 122 122
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
25.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 Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38
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: Titration Period Epogen: Titration Period Epoetin Hospira: Maintenance Period Epogen: Maintenance Period
Hide Arm/Group Description:
During titration period participants who were on Epogen IV regimen prior to this study, were titrated and optimally stabilized to receive SC injection of Epoetin Hospira. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose of study treatment was adjusted to maintain Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).
During titration period participants who were on Epogen IV regimen prior to enrollment in this study, were titrated and optimally stabilized to receive SC injection of Epogen. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).
During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
Overall Number of Participants Analyzed 34 36 104 108
Measure Type: Number
Unit of Measure: percentage of participants
0.0 0.0 0.0 0.0
26.Other Pre-specified Outcome
Title Percentage of Participants With General Tolerability
Hide Description General tolerability was classified as: 1) excellent tolerability = no reaction, 2) good tolerability = minimal reaction, 3) mild intolerability = reaction above that normally observed with any kind of subcutaneous product, 4) moderate intolerability = marked reaction, but no need for discontinuation of treatment and 5) severe intolerability = treatment discontinued due to intolerability.
Time Frame Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38
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: Titration Period Epogen: Titration Period Epoetin Hospira: Maintenance Period Epogen: Maintenance Period
Hide Arm/Group Description:
During titration period participants who were on Epogen IV regimen prior to this study, were titrated and optimally stabilized to receive SC injection of Epoetin Hospira. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose of study treatment was adjusted to maintain Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).
During titration period participants who were on Epogen IV regimen prior to enrollment in this study, were titrated and optimally stabilized to receive SC injection of Epogen. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).
During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
Overall Number of Participants Analyzed 80 84 119 121
Measure Type: Number
Unit of Measure: percentage of participants
Excellent Tolerability 68.8 67.4 63.9 50.8
Good Tolerability 28.8 25.6 27.0 27.9
Mild Intolerability 2.5 2.3 4.9 16.4
Moderate Intolerability 0.0 2.3 0.0 2.5
Severe Intolerability 0.0 0.0 1.6 1.6
27.Other Pre-specified Outcome
Title Percentage of Participants With Local Tolerability
Hide Description Local tolerability was classified as: 1) excellent tolerability = no reaction at site of injection, 2) good tolerability = minimal reaction at site of injection normally observed with any kind of subcutaneous product, 3) mild intolerability = reaction at site of injection above that normally observed with any kind of subcutaneous product, 4) moderate intolerability = marked reaction, but no need for discontinuation of treatment and 5) severe intolerability = treatment discontinued due to intolerability.
Time Frame Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38
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: Titration Period Epogen: Titration Period Epoetin Hospira: Maintenance Period Epogen: Maintenance Period
Hide Arm/Group Description:
During titration period participants who were on Epogen IV regimen prior to this study, were titrated and optimally stabilized to receive SC injection of Epoetin Hospira. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose of study treatment was adjusted to maintain Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).
During titration period participants who were on Epogen IV regimen prior to enrollment in this study, were titrated and optimally stabilized to receive SC injection of Epogen. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).
During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
Overall Number of Participants Analyzed 80 84 119 121
Measure Type: Number
Unit of Measure: percentage of participants
Excellent Tolerability 70.0 66.3 67.2 54.1
Good Tolerability 25.0 25.6 24.6 30.3
Mild Intolerability 3.8 5.8 4.1 9.0
Moderate Intolerability 1.3 1.2 1.6 3.3
Severe Intolerability 0.0 0.0 0.0 2.5
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: Titration Period Epogen: Titration Period Epoetin Hospira: Maintenance Period Epogen: Maintenance Period
Hide Arm/Group Description During titration period participants who were on Epogen IV regimen prior to this study, were titrated and optimally stabilized to receive SC injection of Epoetin Hospira. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose of study treatment was adjusted to maintain Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18). During titration period participants who were on Epogen IV regimen prior to enrollment in this study, were titrated and optimally stabilized to receive SC injection of Epogen. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18). During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38). During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).
All-Cause Mortality
Epoetin Hospira: Titration Period Epogen: Titration Period Epoetin Hospira: Maintenance Period Epogen: Maintenance Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Epoetin Hospira: Titration Period Epogen: Titration Period Epoetin Hospira: Maintenance Period Epogen: Maintenance Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/80 (15.00%)   22/86 (25.58%)   23/122 (18.85%)   33/122 (27.05%) 
Blood and lymphatic system disorders         
Anaemia * 1  0/80 (0.00%)  0/86 (0.00%)  0/122 (0.00%)  1/122 (0.82%) 
Haemorrhagic Anaemia * 1  0/80 (0.00%)  0/86 (0.00%)  1/122 (0.82%)  0/122 (0.00%) 
Coagulopathy * 1  0/80 (0.00%)  1/86 (1.16%)  0/122 (0.00%)  0/122 (0.00%) 
Cardiac disorders         
Angina Pectoris * 1  0/80 (0.00%)  0/86 (0.00%)  1/122 (0.82%)  0/122 (0.00%) 
Angina Unstable * 1  0/80 (0.00%)  0/86 (0.00%)  0/122 (0.00%)  1/122 (0.82%) 
Arrhythmia * 1  0/80 (0.00%)  0/86 (0.00%)  0/122 (0.00%)  1/122 (0.82%) 
Atrial Fibrillation * 1  0/80 (0.00%)  1/86 (1.16%)  1/122 (0.82%)  2/122 (1.64%) 
Cardiac Arrest * 1  1/80 (1.25%)  1/86 (1.16%)  2/122 (1.64%)  0/122 (0.00%) 
Cardiac Failure Congestive * 1  0/80 (0.00%)  0/86 (0.00%)  0/122 (0.00%)  1/122 (0.82%) 
Cardiac Perforation * 1  0/80 (0.00%)  0/86 (0.00%)  0/122 (0.00%)  1/122 (0.82%) 
Cardio-Respiratory Arrest * 1  0/80 (0.00%)  0/86 (0.00%)  0/122 (0.00%)  2/122 (1.64%) 
Myocardial Infarction * 1  0/80 (0.00%)  0/86 (0.00%)  0/122 (0.00%)  1/122 (0.82%) 
Acute Myocardial Infarction * 1  0/80 (0.00%)  2/86 (2.33%)  0/122 (0.00%)  0/122 (0.00%) 
Coronary Artery Disease * 1  0/80 (0.00%)  1/86 (1.16%)  0/122 (0.00%)  0/122 (0.00%) 
Supraventricular Tachycardia * 1  0/80 (0.00%)  1/86 (1.16%)  0/122 (0.00%)  0/122 (0.00%) 
Congenital, familial and genetic disorders         
Gastrointestinal Angiodysplasia * 1  0/80 (0.00%)  1/86 (1.16%)  0/122 (0.00%)  0/122 (0.00%) 
Gastrointestinal disorders         
Abdominal Pain Upper * 1  0/80 (0.00%)  0/86 (0.00%)  0/122 (0.00%)  1/122 (0.82%) 
Colitis Ischaemic * 1  0/80 (0.00%)  0/86 (0.00%)  1/122 (0.82%)  0/122 (0.00%) 
Food Poisoning * 1  0/80 (0.00%)  0/86 (0.00%)  0/122 (0.00%)  1/122 (0.82%) 
Gastroduodenitis * 1  0/80 (0.00%)  0/86 (0.00%)  1/122 (0.82%)  0/122 (0.00%) 
Gastrointestinal Haemorrhage * 1  0/80 (0.00%)  0/86 (0.00%)  1/122 (0.82%)  1/122 (0.82%) 
Gastrooesophageal Reflux Disease * 1  1/80 (1.25%)  0/86 (0.00%)  1/122 (0.82%)  0/122 (0.00%) 
Haemorrhoids * 1  0/80 (0.00%)  0/86 (0.00%)  1/122 (0.82%)  0/122 (0.00%) 
Impaired Gastric Emptying * 1  0/80 (0.00%)  0/86 (0.00%)  1/122 (0.82%)  2/122 (1.64%) 
Oesophagitis * 1  0/80 (0.00%)  0/86 (0.00%)  1/122 (0.82%)  0/122 (0.00%) 
Pancreatitis Acute * 1  0/80 (0.00%)  0/86 (0.00%)  0/122 (0.00%)  1/122 (0.82%) 
Small Intestinal Obstruction * 1  0/80 (0.00%)  1/86 (1.16%)  0/122 (0.00%)  1/122 (0.82%) 
Duodenitis * 1  0/80 (0.00%)  1/86 (1.16%)  0/122 (0.00%)  0/122 (0.00%) 
General disorders         
Asthenia * 1  1/80 (1.25%)  0/86 (0.00%)  0/122 (0.00%)  1/122 (0.82%) 
Non-Cardiac Chest Pain * 1  1/80 (1.25%)  1/86 (1.16%)  2/122 (1.64%)  1/122 (0.82%) 
Pyrexia * 1  0/80 (0.00%)  0/86 (0.00%)  0/122 (0.00%)  1/122 (0.82%) 
General Physical Health Deterioration * 1  1/80 (1.25%)  0/86 (0.00%)  0/122 (0.00%)  0/122 (0.00%) 
Infections and infestations         
Cellulitis * 1  0/80 (0.00%)  1/86 (1.16%)  2/122 (1.64%)  0/122 (0.00%) 
Gangrene * 1  0/80 (0.00%)  0/86 (0.00%)  1/122 (0.82%)  0/122 (0.00%) 
Gastroenteritis * 1  0/80 (0.00%)  0/86 (0.00%)  1/122 (0.82%)  1/122 (0.82%) 
Osteomyelitis * 1  0/80 (0.00%)  0/86 (0.00%)  2/122 (1.64%)  0/122 (0.00%) 
Pneumonia * 1  1/80 (1.25%)  1/86 (1.16%)  3/122 (2.46%)  2/122 (1.64%) 
Urinary Tract Infection * 1  1/80 (1.25%)  0/86 (0.00%)  1/122 (0.82%)  0/122 (0.00%) 
Viral Infection * 1  0/80 (0.00%)  0/86 (0.00%)  0/122 (0.00%)  1/122 (0.82%) 
Bronchitis * 1  1/80 (1.25%)  0/86 (0.00%)  0/122 (0.00%)  0/122 (0.00%) 
Colon Gangrene * 1  1/80 (1.25%)  0/86 (0.00%)  0/122 (0.00%)  0/122 (0.00%) 
Cystitis * 1  0/80 (0.00%)  1/86 (1.16%)  0/122 (0.00%)  0/122 (0.00%) 
Graft Infection * 1  0/80 (0.00%)  1/86 (1.16%)  0/122 (0.00%)  1/122 (0.82%) 
Influenza * 1  1/80 (1.25%)  0/86 (0.00%)  0/122 (0.00%)  0/122 (0.00%) 
Necrotising Fasciitis * 1  1/80 (1.25%)  0/86 (0.00%)  0/122 (0.00%)  0/122 (0.00%) 
Oesophageal Candidiasis * 1  1/80 (1.25%)  0/86 (0.00%)  0/122 (0.00%)  0/122 (0.00%) 
Pyelonephritis * 1  0/80 (0.00%)  1/86 (1.16%)  0/122 (0.00%)  0/122 (0.00%) 
Pyelonephritis Acute * 1  0/80 (0.00%)  1/86 (1.16%)  0/122 (0.00%)  0/122 (0.00%) 
Sepsis * 1  2/80 (2.50%)  2/86 (2.33%)  0/122 (0.00%)  0/122 (0.00%) 
Injury, poisoning and procedural complications         
Arteriovenous Fistula Occlusion * 1  0/80 (0.00%)  0/86 (0.00%)  0/122 (0.00%)  1/122 (0.82%) 
Arteriovenous Fistula Thrombosis * 1  0/80 (0.00%)  0/86 (0.00%)  0/122 (0.00%)  1/122 (0.82%) 
Graft Haemorrhage * 1  0/80 (0.00%)  0/86 (0.00%)  0/122 (0.00%)  1/122 (0.82%) 
Humerus Fracture * 1  0/80 (0.00%)  0/86 (0.00%)  1/122 (0.82%)  0/122 (0.00%) 
Multiple Fractures * 1  0/80 (0.00%)  0/86 (0.00%)  1/122 (0.82%)  0/122 (0.00%) 
Spinal Compression Fracture * 1  0/80 (0.00%)  0/86 (0.00%)  1/122 (0.82%)  0/122 (0.00%) 
Tibia Fracture * 1  0/80 (0.00%)  0/86 (0.00%)  1/122 (0.82%)  0/122 (0.00%) 
Vascular Graft Thrombosis * 1  0/80 (0.00%)  0/86 (0.00%)  0/122 (0.00%)  1/122 (0.82%) 
Arteriovenous Fistula Site Complication * 1  1/80 (1.25%)  0/86 (0.00%)  0/122 (0.00%)  0/122 (0.00%) 
Graft Thrombosis * 1  0/80 (0.00%)  1/86 (1.16%)  0/122 (0.00%)  0/122 (0.00%) 
Limb Traumatic Amputation * 1  1/80 (1.25%)  0/86 (0.00%)  0/122 (0.00%)  0/122 (0.00%) 
Investigations         
Blood Culture Positive * 1  0/80 (0.00%)  0/86 (0.00%)  1/122 (0.82%)  0/122 (0.00%) 
Metabolism and nutrition disorders         
Fluid Overload * 1  1/80 (1.25%)  1/86 (1.16%)  0/122 (0.00%)  1/122 (0.82%) 
Hyperkalaemia * 1  1/80 (1.25%)  0/86 (0.00%)  2/122 (1.64%)  2/122 (1.64%) 
Hypoglycaemia * 1  0/80 (0.00%)  0/86 (0.00%)  0/122 (0.00%)  4/122 (3.28%) 
Musculoskeletal and connective tissue disorders         
Osteoarthritis * 1  0/80 (0.00%)  0/86 (0.00%)  0/122 (0.00%)  1/122 (0.82%) 
Pain In Extremity * 1  0/80 (0.00%)  0/86 (0.00%)  0/122 (0.00%)  1/122 (0.82%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Carcinoid Tumour Of The Stomach * 1  0/80 (0.00%)  0/86 (0.00%)  1/122 (0.82%)  0/122 (0.00%) 
Colon Cancer * 1  1/80 (1.25%)  0/86 (0.00%)  0/122 (0.00%)  1/122 (0.82%) 
Multiple Myeloma * 1  0/80 (0.00%)  0/86 (0.00%)  0/122 (0.00%)  1/122 (0.82%) 
Non-Small Cell Lung Cancer * 1  0/80 (0.00%)  0/86 (0.00%)  0/122 (0.00%)  1/122 (0.82%) 
Uterine Leiomyoma * 1 [1]  0/40 (0.00%)  1/40 (2.50%)  0/59 (0.00%)  0/67 (0.00%) 
Vulval Cancer * 1 [1]  1/40 (2.50%)  0/40 (0.00%)  0/59 (0.00%)  0/67 (0.00%) 
Vulval Cancer Stage 0 * 1 [1]  0/40 (0.00%)  1/40 (2.50%)  0/59 (0.00%)  0/67 (0.00%) 
Nervous system disorders         
Cervical Cord Compression * 1  0/80 (0.00%)  0/86 (0.00%)  0/122 (0.00%)  1/122 (0.82%) 
Dizziness * 1  0/80 (0.00%)  0/86 (0.00%)  0/122 (0.00%)  1/122 (0.82%) 
Hepatic Encephalopathy * 1  0/80 (0.00%)  0/86 (0.00%)  0/122 (0.00%)  1/122 (0.82%) 
Mental Impairment * 1  0/80 (0.00%)  0/86 (0.00%)  1/122 (0.82%)  2/122 (1.64%) 
Presyncope * 1  0/80 (0.00%)  0/86 (0.00%)  0/122 (0.00%)  1/122 (0.82%) 
Syncope * 1  0/80 (0.00%)  0/86 (0.00%)  0/122 (0.00%)  1/122 (0.82%) 
Transient Ischaemic Attack * 1  0/80 (0.00%)  0/86 (0.00%)  0/122 (0.00%)  1/122 (0.82%) 
Metabolic Encephalopathy * 1  0/80 (0.00%)  1/86 (1.16%)  0/122 (0.00%)  0/122 (0.00%) 
Psychiatric disorders         
Hallucination * 1  0/80 (0.00%)  1/86 (1.16%)  0/122 (0.00%)  0/122 (0.00%) 
Renal and urinary disorders         
Azotaemia * 1  0/80 (0.00%)  0/86 (0.00%)  1/122 (0.82%)  0/122 (0.00%) 
Renal Cyst Haemorrhage * 1  0/80 (0.00%)  0/86 (0.00%)  0/122 (0.00%)  1/122 (0.82%) 
Reproductive system and breast disorders         
Menorrhagia * 1 [1]  0/40 (0.00%)  1/40 (2.50%)  0/59 (0.00%)  0/67 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pneumonia Aspiration * 1  0/80 (0.00%)  0/86 (0.00%)  1/122 (0.82%)  0/122 (0.00%) 
Pulmonary Oedema * 1  0/80 (0.00%)  1/86 (1.16%)  0/122 (0.00%)  1/122 (0.82%) 
Respiratory Failure * 1  1/80 (1.25%)  1/86 (1.16%)  1/122 (0.82%)  1/122 (0.82%) 
Acute Respiratory Failure * 1  1/80 (1.25%)  1/86 (1.16%)  0/122 (0.00%)  0/122 (0.00%) 
Atelectasis * 1  0/80 (0.00%)  1/86 (1.16%)  0/122 (0.00%)  0/122 (0.00%) 
Chronic Obstructive Pulmonary Disease * 1  0/80 (0.00%)  2/86 (2.33%)  0/122 (0.00%)  0/122 (0.00%) 
Dyspnoea * 1  1/80 (1.25%)  0/86 (0.00%)  0/122 (0.00%)  0/122 (0.00%) 
Skin and subcutaneous tissue disorders         
Decubitus Ulcer * 1  0/80 (0.00%)  1/86 (1.16%)  0/122 (0.00%)  1/122 (0.82%) 
Erythema * 1  0/80 (0.00%)  1/86 (1.16%)  0/122 (0.00%)  0/122 (0.00%) 
Vascular disorders         
Aortic Stenosis * 1  0/80 (0.00%)  0/86 (0.00%)  0/122 (0.00%)  1/122 (0.82%) 
Hypotension * 1  0/80 (0.00%)  0/86 (0.00%)  0/122 (0.00%)  1/122 (0.82%) 
Jugular Vein Thrombosis * 1  0/80 (0.00%)  0/86 (0.00%)  0/122 (0.00%)  1/122 (0.82%) 
Orthostatic Hypotension * 1  0/80 (0.00%)  0/86 (0.00%)  0/122 (0.00%)  1/122 (0.82%) 
Vena Cava Thrombosis * 1  0/80 (0.00%)  0/86 (0.00%)  0/122 (0.00%)  1/122 (0.82%) 
Aneurysm Ruptured * 1  0/80 (0.00%)  1/86 (1.16%)  0/122 (0.00%)  0/122 (0.00%) 
Hypertensive Crisis * 1  1/80 (1.25%)  0/86 (0.00%)  0/122 (0.00%)  0/122 (0.00%) 
*
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: Titration Period Epogen: Titration Period Epoetin Hospira: Maintenance Period Epogen: Maintenance Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   16/80 (20.00%)   10/86 (11.63%)   27/122 (22.13%)   24/122 (19.67%) 
Gastrointestinal disorders         
Nausea * 1  0/80 (0.00%)  0/86 (0.00%)  10/122 (8.20%)  8/122 (6.56%) 
General disorders         
Injection Site Pain * 1  0/80 (0.00%)  0/86 (0.00%)  3/122 (2.46%)  8/122 (6.56%) 
Pyrexia * 1  0/80 (0.00%)  0/86 (0.00%)  8/122 (6.56%)  3/122 (2.46%) 
Injury, poisoning and procedural complications         
Fall * 1  0/80 (0.00%)  0/86 (0.00%)  8/122 (6.56%)  3/122 (2.46%) 
Procedural Hypotension * 1  5/80 (6.25%)  2/86 (2.33%)  0/122 (0.00%)  0/122 (0.00%) 
Investigations         
Eosinophil Count Increased * 1  4/80 (5.00%)  0/86 (0.00%)  0/122 (0.00%)  0/122 (0.00%) 
Metabolism and nutrition disorders         
Hyperkalaemia * 1  4/80 (5.00%)  1/86 (1.16%)  0/122 (0.00%)  0/122 (0.00%) 
Musculoskeletal and connective tissue disorders         
Muscle Spasms * 1  0/80 (0.00%)  5/86 (5.81%)  0/122 (0.00%)  0/122 (0.00%) 
Nervous system disorders         
Headache * 1  4/80 (5.00%)  4/86 (4.65%)  0/122 (0.00%)  0/122 (0.00%) 
Dizziness * 1  4/80 (5.00%)  0/86 (0.00%)  3/122 (2.46%)  8/122 (6.56%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
[Not Specified]
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01473420    
Other Study ID Numbers: EPOE-10-13
C3461003 ( Other Identifier: Alias Study Number )
First Submitted: November 2, 2011
First Posted: November 17, 2011
Results First Submitted: May 16, 2018
Results First Posted: June 20, 2018
Last Update Posted: August 9, 2018