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CompletedNCT02253654Updated May 19, 2017Results posted

Evaluation of Two Epoetin Alfa Dosing Strategies in Subjects With Chronic Kidney Disease Receiving Hemodialysis

A Phase 4 interventional study of Epoetin alfa in Renal Insufficiency, Chronic, Anemia and Renal Dialysis, sponsored by Amgen. Completed at 37 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-19.

Sponsored by Amgen · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
216
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to compare two different dosing methods of epoetin alfa and their effectiveness in maintaining hemoglobin levels between 10.0 to 11.0 g/dL in in patients with chronic kidney disease (CKD) receiving hemodialysis.

02

Conditions studied

  • Renal Insufficiency, Chronic
  • Anemia
  • Renal Dialysis
  • Erythrocyte Transfusion

Keywords

  • Chronic Kidney Disease
  • Anemia
  • Hemodialysis
  • Red Blood Cell Transfusion
03

In context

Renal Insufficiency, Chronic

3,224 studies on the registry are indexed under Renal Insufficiency, Chronic; 706 are open to participants now.

This study's enrollment of 216 is above the median of 74 across 2,229 interventional studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

Amgen is the lead sponsor of 1,044 studies on the registry; 51 are open to participants now.

Of its 246 completed or terminated interventional studies of FDA-regulated products, 164 (67%) have results posted.

Browse Amgen studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Informed consent obtained prior to initiation of any study-specific activities/procedures
  • Age 18 or older
  • Prescribed hemodialysis three times a week (TIW) for ≥ 12 weeks prior to randomization
  • Prescribed IV administration of epoetin alfa TIW for ≥ 12 weeks prior to randomization
  • Prescribed ≥ 3000 Units/week (ie, ≥ 1000 Units/administration) and \< 90,000 Units/week (ie, \< 30,000 Units/administration) of epoetin alfa during the 4 weeks prior to randomization
  • Received ≥ 4 doses of epoetin alfa during the 2 weeks prior to randomization
  • Hemoglobin concentration ≤ 11.0 g/dL, per the most recent local laboratory value obtained during the 2 weeks prior to randomization
  • Hemoglobin concentration ≤ 11.0 g/dL, at the screening visit, using the hemoglobin point of care device provided by Amgen
  • Iron replete, defined as a transferrin saturation (TSAT) ≥ 20% and a ferritin ≥ 100 ng/mL, per the most recent local laboratory value obtained during the 4 weeks prior to randomization

Exclusion criteria

Exclusion Criteria:

  • Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s) prior to randomization
  • Other investigational procedures while participating in this study are excluded
  • Systemic hematologic disease (eg, sickle cell anemia, myelodysplastic syndrome, hematologic malignancy)
  • Current or prior malignancy within 5 years of randomization, with the exception of non-melanoma skin cancers, cervical or breast ductal carcinoma in situ
  • Treatment for any malignancy (eg, radiation, chemotherapy, hormone therapy or biologics) within 5 years of randomization, with the exception of locally excised non-melanoma skin cancers, cervical or breast ductal carcinoma in situ
  • Subject is currently pregnant or planning to become pregnant during treatment and for 30 days after the end of treatment
  • Subject is currently breast feeding or planning on breast feeding during treatment and for 30 days after the end of treatment
  • Females of reproductive potential who are not willing to use an acceptable method of effective contraception during treatment and for at least 30 days after the end of treatment
  • Currently receiving IV antibiotics
  • Currently receiving systemic immunosuppressive therapy known to cause anemia, including treatment for active hepatitis (eg, azathioprine, mycophenolate mofetil, ≥ 10 mg prednisone [or equivalent]/day, interferon)
  • Known human immunodeficiency virus (HIV) positive
  • Known neutralizing anti-erythropoietic protein antibodies
  • Known sensitivity to epoetin alfa
  • Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, planned vacations where away from dialysis unit for more than 2 weeks) to the best of the subject and investigator's knowledge
  • History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
  • Previously entered this study

  • Occurrence of any of the following within 8 weeks prior to randomization:

    • Seizure
    • Clinically relevant active bleeding (eg, gastrointestinal bleed)
    • RBC transfusion
    • Any hospitalization or observational stay > 24 hours
  • Uncontrolled hypertension, per the investigator within the 4 weeks prior to randomization
  • Expected or scheduled solid organ transplant(eg, kidney) within 40 weeks after randomization
  • Expected or scheduled to change dialysis modality (eg, peritoneal dialysis, home hemodialysis) within 40 weeks after randomization
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
216 participants (actual)

Study arms

  • Experimental
    Epoetin alfa Alternative Titration

    Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.

    Drug: Epoetin alfa

  • Active comparator
    Epoetin alfa USPI Titration

    Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.

    Drug: Epoetin alfa

Interventions

  • DrugEpoetin alfa

    Administered intravenously (IV) three times a week (TIW) by appropriately trained healthcare professionals during hemodialysis.

    Also known as: Epogen

06

What researchers measure

Primary outcomes

  1. Percentage of Hemoglobin Measurements Within 10 to 11 g/dL During the Evaluation Period

    Hemoglobin was measured every 2 weeks during the evaluation period. The percentage of these measurements that were within the range of 10-11 g/dL was calculated for each participant.

    Time frame: The evaluation period (weeks 13-37)

Secondary outcomes

  1. Hemoglobin Concentration at Each Visit

    Time frame: Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37

  2. Percentage of Participants With Transfusion Events Overall and During Each Study Period

    The percentage of participants who received red blood cell (RBC) transfusions during the study and during each study period.

    Time frame: Overall Study: Study week 1 to week 41; Titration Period: Study week 1 to week 12; Evaluation Period: Study week 13 to week 37; Safety Follow-up Period: Study week 38 to week 41

  3. Hemoglobin Rate of Change at Each Visit

    Hemoglobin rate of change (ROC) was calculated for each visit using the following formula: ROC = (current visit hemoglobin value - previous visit hemoglobin value) / number of days between each visit \* 14. A positive value indicates a rate of rise and a negative value indicates a rate of decline.

    Time frame: Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37

  4. Hemoglobin Intra-subject Variability

    Intra-subject variability was defined for each participant as the standard deviation (SD) of all of the hemoglobin concentrations during the evaluation period for the participant. The mean intra-subject SD for all participants is the sum of the intra-subject SDs divided by the total number of participants evaluated.

    Time frame: The evaluation period (weeks 13 to 37)

  5. Percentage of Participants With Hemoglobin Excursions at Each Visit

    An excursion is identified as an event when a hemoglobin concentration fell below or exceeded the pre-specified thresholds of: - \< 9.0 g/dL, or - \> 11.0 g/dL, or - \> 12.0 g/dL. The percentage of participants with any excursions and excursions in each subcategory at each time point and overall during the study are reported.

    Time frame: Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37

  6. Weekly Epoetin Alfa Dose at Each Visit

    Time frame: Weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35

  7. Number of RBC Units Transfused Overall and During Each Study Period

    The number of red blood cell (RBC) units transfused during the study and during each study period.

    Time frame: Overall Study: Study week 1 to week 41; Titration Period: Study week 1 to week 12; Evaluation Period: Study week 13 to week 37; Safety Follow-up Period: Study week 38 to week 41

07

Results

Posted May 12, 2017

Participant flow

This study was conducted at 31 centers in the United States. Participants were enrolled from 01 April 2015 to 17 August 2015.

Participant flow — Overall Study
MilestoneEpoetin Alfa Alternative TitrationEpoetin Alfa USPI Titration
Started108108
Received treatment104107
Completed8590
Not completed2318
Withdrew: Withdrawal by subject124
Withdrew: Decision by sponsor11
Withdrew: Lost to follow-up25
Withdrew: Death47
Withdrew: Did not receive study treatment41

Outcome measures

PrimaryPercentage of Hemoglobin Measurements Within 10 to 11 g/dL During the Evaluation Period

Hemoglobin was measured every 2 weeks during the evaluation period. The percentage of these measurements that were within the range of 10-11 g/dL was calculated for each participant.

Time frame:
The evaluation period (weeks 13-37)
Reported as:
Mean · percentage of hemoglobin measurements
Percentage of Hemoglobin Measurements Within 10 to 11 g/dL During the Evaluation Period
percentage of hemoglobin measurementsEpoetin Alfa Alternative TitrationEpoetin Alfa USPI Titration
Percentage of Hemoglobin Measurements Within 10 to 11 g/dL During the Evaluation Period46.41 ± 2.3946.02 ± 2.56
Statistical analysis
  • Epoetin Alfa Alternative Titration vs Epoetin Alfa USPI Titration · t-test, 1 sided · p = 0.46 · Treatment difference: 0.39
SecondaryHemoglobin Concentration at Each Visit
Time frame:
Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37
Reported as:
Mean · g/dL
Hemoglobin Concentration at Each Visit
g/dLEpoetin Alfa Alternative TitrationEpoetin Alfa USPI Titration
Baseline (n = 89, 100)10.15 ± 0.6610.04 ± 0.81
Week 3 (n = 89, 100)10.54 ± 0.8810.34 ± 0.97
Week 5 (n = 89, 99)10.66 ± 0.9310.51 ± 1.04
Week 7 (n = 88, 97)10.45 ± 1.0210.28 ± 1.07
Week 9 (n = 89, 100)10.32 ± 1.169.97 ± 0.87
Week 11 (n = 88, 99)10.33 ± 1.0510.15 ± 0.88
Week 13 (n = 89, 100)10.28 ± 1.049.99 ± 0.91
Week 15 (n = 89, 100)10.46 ± 1.389.98 ± 0.93
Week 17 (n = 89, 100)10.20 ± 1.0510.01 ± 1.22
Week 19 (n = 89, 100)10.37 ± 1.149.94 ± 0.87
Week 21 (n = 87, 99)10.33 ± 1.019.92 ± 0.81
Week 23 (n = 88, 98)10.46 ± 1.0510.03 ± 0.86
Week 25 (n = 87, 98)10.56 ± 1.009.94 ± 0.97
Week 27 (n = 88, 94)10.32 ± 1.109.97 ± 0.86
Week 29 (n =89, 92)10.34 ± 1.0110.02 ± 1.07
Week 31 (n = 85, 89)10.34 ± 0.959.96 ± 1.07
Week 33 (n = 86, 90)10.18 ± 1.0010.05 ± 0.92
Week 35 (n = 87, 88)10.12 ± 1.239.94 ± 0.90
Week 37 (n = 87, 93)10.10 ± 1.119.86 ± 0.85
SecondaryPercentage of Participants With Transfusion Events Overall and During Each Study Period

The percentage of participants who received red blood cell (RBC) transfusions during the study and during each study period.

Time frame:
Overall Study: Study week 1 to week 41; Titration Period: Study week 1 to week 12; Evaluation Period: Study week 13 to week 37; Safety Follow-up Period: Study week 38 to week 41
Reported as:
Number · percentage of participants
Percentage of Participants With Transfusion Events Overall and During Each Study Period
percentage of participantsEpoetin Alfa Alternative TitrationEpoetin Alfa USPI Titration
Overall (n = 89, 100)6.712.0
Titration Period (n = 89, 100)2.21.0
Evaluation Period (n = 89, 100)5.610.0
Safety Follow-up Period (n = 83, 90)1.21.1
SecondaryHemoglobin Rate of Change at Each Visit

Hemoglobin rate of change (ROC) was calculated for each visit using the following formula: ROC = (current visit hemoglobin value - previous visit hemoglobin value) / number of days between each visit \* 14. A positive value indicates a rate of rise and a negative value indicates a rate of decline.

Time frame:
Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37
Reported as:
Mean · g/dL/2 weeks
Hemoglobin Rate of Change at Each Visit
g/dL/2 weeksEpoetin Alfa Alternative TitrationEpoetin Alfa USPI Titration
Week 3 (n = 89, 100)0.36 ± 0.790.27 ± 0.71
Week 5 (n = 89, 99)0.10 ± 0.810.13 ± 1.01
Week 7 (n = 88, 97)-0.22 ± 0.90-0.19 ± 1.42
Week 9 (n = 89, 100)-0.12 ± 0.93-0.28 ± 1.08
Week 11 (n = 88, 99)0.02 ± 1.010.19 ± 0.67
Week 13 (n = 89, 100)-0.05 ± 0.93-0.19 ± 0.97
Week 15 (n = 89, 100)0.19 ± 1.01-0.01 ± 0.87
Week 17 (n = 89, 100)-0.22 ± 1.080.02 ± 1.07
Week 19 (n = 89, 100)0.18 ± 0.97-0.06 ± 1.25
Week 21 (n = 87, 99)-0.02 ± 0.74-0.06 ± 0.72
Week 23 (n = 88, 98)0.16 ± 0.870.09 ± 0.78
Week 25 (n = 87, 98)0.07 ± 0.78-0.06 ± 0.84
Week 27 (n = 88, 94)-0.18 ± 0.770.01 ± 0.85
Week 29 (n =89, 92)0.04 ± 0.860.05 ± 0.73
Week 31 (n = 85, 89)-0.02 ± 0.72-0.03 ± 0.74
Week 33 (n = 86, 90)-0.16 ± 0.820.06 ± 0.74
Week 35 (n = 87, 88)-0.05 ± 0.98-0.13 ± 0.72
Week 37 (n = 87, 93)-0.04 ± 1.00-0.03 ± 0.64
SecondaryHemoglobin Intra-subject Variability

Intra-subject variability was defined for each participant as the standard deviation (SD) of all of the hemoglobin concentrations during the evaluation period for the participant. The mean intra-subject SD for all participants is the sum of the intra-subject SDs divided by the total number of participants evaluated.

Time frame:
The evaluation period (weeks 13 to 37)
Reported as:
Mean · g/dL
Hemoglobin Intra-subject Variability
g/dLEpoetin Alfa Alternative TitrationEpoetin Alfa USPI Titration
Hemoglobin Intra-subject Variability0.74 ± 0.300.70 ± 0.32
SecondaryPercentage of Participants With Hemoglobin Excursions at Each Visit

An excursion is identified as an event when a hemoglobin concentration fell below or exceeded the pre-specified thresholds of: - \< 9.0 g/dL, or - \> 11.0 g/dL, or - \> 12.0 g/dL. The percentage of participants with any excursions and excursions in each subcategory at each time point and overall during the study are reported.

Time frame:
Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37
Reported as:
Number · percentage of participants
Percentage of Participants With Hemoglobin Excursions at Each Visit
percentage of participantsEpoetin Alfa Alternative TitrationEpoetin Alfa USPI Titration
Overall Excursions (n = 89, 100)91.093.0
Overall Excursions < 9.0 (n = 89, 100)48.361.0
Overall Excursions > 11.0 (n = 89, 100)80.983.0
Overall Excursions > 12.0 (n = 89, 100)25.819.0
Baseline Excursions (n = 89, 100)3.411.0
Baseline Excursions < 9.0 (n = 89, 100)3.411.0
Baseline Excursions > 11.0 (n = 89, 100)0.00.0
Baseline Excursions > 12.0 (n = 89, 100)0.00.0
Week 3 Excursions (n = 89, 100)29.227.0
Week 3 Excursions < 9.0 (n = 89, 100)2.26.0
Week 3 Excursions > 11.0 (n = 89, 100)27.021.0
Week 3 Excursions > 12.0 (n = 89, 100)5.65.0
Week 5 Excursions (n = 89, 99)36.029.3
Week 5 Excursions < 9.0 (n = 89, 99)1.14.0
Week 5 Excursions > 11.0 (n = 89, 99)34.825.3
Week 5 Excursions > 12.0 (n = 89, 99)5.67.1
Week 7 Excursions (n = 88, 97)27.328.9
Week 7 Excursions < 9.0 (n = 88, 97)6.88.2
Week 7 Excursions > 11.0 (n = 88, 97)20.520.6
Week 7 Excursions > 12.0 (n = 88, 97)3.44.1
Week 9 Excursions (n = 89, 100)29.217.0
Week 9 Excursions < 9.0 (n = 89, 100)9.010.0
Week 9 Excursions > 11.0 (n = 89, 100)20.27.0
Week 9 Excursions > 12.0 (n = 89, 100)3.40.0
Week 11 Excursions (n = 88, 99)22.723.2
Week 11 Excursions < 9.0 (n = 88, 99)4.57.1
Week 11 Excursions > 11.0 (n = 88, 99)18.216.2
Week 11 Excursions > 12.0 (n = 88, 99)2.31.0
Week 13 Excursions (n = 89, 100)25.821.0
Week 13 Excursions < 9.0 (n = 89, 100)7.99.0
Week 13 Excursions > 11.0 (n = 89, 100)18.012.0
Week 13 Excursions > 12.0 (n = 89, 100)4.51.0
Week 15 Excursions (n = 89, 100)27.024.0
Week 15 Excursions < 9.0 (n = 89, 100)5.613.0
Week 15 Excursions > 11.0 (n = 89, 100)21.311.0
Week 15 Excursions > 12.0 (n = 89, 100)6.70.0
Week 17 Excursions (n = 89, 100)23.621.0
Week 17 Excursions < 9.0 (n = 89, 100)9.012.0
Week 17 Excursions > 11.0 (n = 89, 100)14.69.0
Week 17 Excursions > 12.0 (n = 89, 100)4.53.0
Week 19 Excursions (n = 89, 100)28.119.0
Week 19 Excursions < 9.0 (n = 89, 100)9.013.0
Week 19 Excursions > 11.0 (n = 89, 100)19.16.0
Week 19 Excursions > 12.0 (n = 89, 100)9.00.0
Week 21 Excursions (n = 87, 99)27.617.2
Week 21 Excursions < 9.0 (n = 87, 99)8.012.1
Week 21 Excursions > 11.0 (n = 87, 99)19.55.1
Week 21 Excursions > 12.0 (n = 87, 99)3.40.0
Week 23 Excursions (n = 88, 98)29.520.4
Week 23 Excursions < 9.0 (n = 88, 98)6.810.2
Week 23 Excursions > 11.0 (n = 88, 98)22.710.2
Week 23 Excursions > 12.0 (n = 88, 98)5.70.0
Week 25 Excursions (n = 87, 98)28.720.4
Week 25 Excursions < 9.0 (n = 87, 98)2.313.3
Week 25 Excursions > 11.0 (n = 87, 98)26.47.1
Week 25 Excursions > 12.0 (n = 87, 98)5.72.0
Week 27 Excursions (n = 88, 94)29.521.3
Week 27 Excursions < 9.0 (n = 88, 94)10.216.0
Week 27 Excursions > 11.0 (n = 88, 94)19.35.3
Week 27 Excursions > 12.0 (n = 88, 94)3.40.0
Week 29 Excursions (n = 89, 92)25.829.3
Week 29 Excursions < 9.0 (n = 89, 92)5.616.3
Week 29 Excursions > 11.0 (n = 89, 92)20.213.0
Week 29 Excursions > 12.0 (n = 89, 92)4.52.2
Week 31 Excursions (n = 85, 89)20.028.1
Week 31 Excursions < 9.0 (n = 85, 89)4.716.9
Week 31 Excursions > 11.0 (n = 85, 89)15.311.2
Week 31 Excursions > 12.0 (n = 85, 89)5.91.1
Week 33 Excursions (n = 86, 90)22.122.2
Week 33 Excursions < 9.0 (n = 86, 90)7.011.1
Week 33 Excursions > 11.0 (n = 86, 90)15.111.1
Week 33 Excursions > 12.0 (n = 86, 90)3.52.2
Week 35 Excursions (n = 87, 88)26.421.6
Week 35 Excursions < 9.0 (n = 87, 88)11.513.6
Week 35 Excursions > 11.0 (n = 87, 88)14.98.0
Week 35 Excursions > 12.0 (n = 87, 88)4.60.0
Week 37 Excursions (n = 87, 93)20.717.2
Week 37 Excursions < 9.0 (n = 87, 93)8.012.9
Week 37 Excursions > 11.0 (n = 87, 93)12.64.3
Week 37 Excursions > 12.0 (n = 87, 93)3.40.0
SecondaryWeekly Epoetin Alfa Dose at Each Visit
Time frame:
Weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35
Reported as:
Mean · units
Weekly Epoetin Alfa Dose at Each Visit
unitsEpoetin Alfa Alternative TitrationEpoetin Alfa USPI Titration
Week 1 (n = 89, 100)13139.9 ± 9360.110400 ± 8439.9
Week 3 (n = 89, 100)9683.7 ± 9162.96912.5 ± 7459.4
Week 5 (n = 89, 100)8324.2 ± 8689.76874.0 ± 8204.3
Week 7 (n = 89, 100)9319.1 ± 7977.56411.0 ± 7040.6
Week 9 (n = 89, 100)9253.4 ± 8536.98003.0 ± 7292.8
Week 11 (n = 89, 100)10039.3 ± 9194.16483.0 ± 6854.9
Week 13 (n = 89, 100)10358.4 ± 10247.77387.5 ± 7271.6
Week 15 (n = 89, 100)8889.3 ± 8316.86874.5 ± 5952.9
Week 17 (n = 89, 100)10251.7 ± 9973.76924.5 ± 6211.1
Week 19 (n = 89, 100)10475.8 ± 10437.07112.5 ± 6300.4
Week 21 (n = 89, 99)9605.1 ± 8225.06909.6 ± 6102.5
Week 23 (n = 89, 98)8905.1 ± 7748.36830.1 ± 6397.0
Week 25 (n = 89, 98)7543.8 ± 7225.17486.7 ± 6676.2
Week 27 (n = 89, 96)9765.7 ± 12013.76662.5 ± 6362.8
Week 29 (n =89, 94)9088.8 ± 10146.96083.0 ± 6149.1
Week 31 (n = 88, 91)8543.2 ± 10821.76673.1 ± 6277.6
Week 33 (n = 87, 90)9019.0 ± 10466.96235.6 ± 6041.6
Week 35 (n = 87, 90)8709.2 ± 8631.95950.6 ± 5364.6
SecondaryNumber of RBC Units Transfused Overall and During Each Study Period

The number of red blood cell (RBC) units transfused during the study and during each study period.

Time frame:
Overall Study: Study week 1 to week 41; Titration Period: Study week 1 to week 12; Evaluation Period: Study week 13 to week 37; Safety Follow-up Period: Study week 38 to week 41
Reported as:
Number · participants
Number of RBC Units Transfused Overall and During Each Study Period
participantsEpoetin Alfa Alternative TitrationEpoetin Alfa USPI Titration
Overall Study: 1 RBC Unit (n = 89, 100)14
Overall Study: 2 RBC Units (n = 89, 100)25
Overall Study: 3 RBC Units (n = 89, 100)12
Overall Study: > 3 RBC Units (n = 89, 100)21
Titration Period: 1 RBC Unit (n = 89, 100)01
Titration Period: 2 RBC Units (n = 89, 100)10
Titration Period: 3 RBC Units (n = 89, 100)10
Titration Period: > 3 RBC Units (n = 89, 100)00
Evaluation Period: 1 RBC Unit (n = 89, 100)13
Evaluation Period: 2 RBC Units (n = 89, 100)34
Evaluation Period: 3 RBC Units (n = 89, 100)12
Evaluation Period: > 3 RBC Units (n = 89, 100)01
Safety Follow-up Period: 1 RBC Unit (n = 83, 90)00
Safety Follow-up Period: 2 RBC Units (n = 83, 90)11
Safety Follow-up Period: 3 RBC Units (n = 83, 90)00
Safety Follow-up Period: >3 RBC Units (n = 83, 90)00

Adverse events

Collected over 41 Weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Epoetin Alfa Alternative Titration—37/104 (35.6%)19/104 (18.3%)
Epoetin Alfa USPI Titration—39/107 (36.4%)26/107 (24.3%)
Most frequent serious events
Showing 10 of 107
Most frequent serious events
EventEpoetin Alfa Alternative TitrationEpoetin Alfa USPI Titration
Fluid overloadMetabolism and nutrition disorders3/1049/107
PneumoniaInfections and infestations2/1046/107
Cerebrovascular accidentNervous system disorders0/1044/107
Cardiac arrestCardiac disorders3/1041/107
Cardiac failure congestiveCardiac disorders3/1042/107
HyperkalaemiaMetabolism and nutrition disorders3/1041/107
Gastrointestinal haemorrhageGastrointestinal disorders2/1043/107
Pleural effusionRespiratory, thoracic and mediastinal disorders1/1043/107
Non-cardiac chest painGeneral disorders2/1040/107
Cholecystitis acuteHepatobiliary disorders2/1040/107
Most frequent other events
Most frequent other events
EventEpoetin Alfa Alternative TitrationEpoetin Alfa USPI Titration
DiarrhoeaGastrointestinal disorders8/1048/107
HypertensionVascular disorders5/1048/107
AnaemiaBlood and lymphatic system disorders2/1047/107
DyspnoeaRespiratory, thoracic and mediastinal disorders6/1044/107
Haemoglobin increasedInvestigations3/1046/107

Baseline characteristics

All randomized participants

Age, Continuous
Age, Continuous(years)Epoetin Alfa Alternative TitrationEpoetin Alfa USPI TitrationTotal
Mean60.9 ± 13.358.7 ± 14.259.8 ± 1.8
Sex: Female, Male
Sex: Female, Male(Participants)Epoetin Alfa Alternative TitrationEpoetin Alfa USPI TitrationTotal
Female484088
Male6068128
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Epoetin Alfa Alternative TitrationEpoetin Alfa USPI TitrationTotal
Asian7714
Black5350103
Native Hawaiian or other Pacific Islander011
White404080
Other81018
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Epoetin Alfa Alternative TitrationEpoetin Alfa USPI TitrationTotal
Hispanic/Latino303969
Not Hispanic/Latino7869147
08

Study locations

37 sites
  • Research Site
    Cerritos, California 90703, United States
  • Research Site
    Glendale, California 91204, United States
  • Research Site
    Los Angeles, California 90022, United States
  • Research Site
    Los Angeles, California 90057, United States
  • Research Site
    Montebello, California 90640, United States
  • Research Site
    Riverside, California 92501, United States
  • Research Site
    San Diego, California 92115, United States
  • Research Site
    Simi Valley, California 93065, United States
  • Research Site
    Vacaville, California 95687, United States
  • Research Site
    Whittier, California 90606, United States
  • Research Site
    Miami, Florida 33150, United States
  • Research Site
    Miami Gardens, Florida 33169, United States
  • Research Site
    Pembroke Pines, Florida 33025, United States
  • Research Site
    Macon, Georgia 31217, United States
  • Research Site
    Statesboro, Georgia 30458, United States
  • Research Site
    Merrillville, Indiana 46410, United States
  • Research Site
    Michigan City, Indiana 46360, United States
  • Research Site
    Detroit, Michigan 48202, United States
  • Research Site
    Pontiac, Michigan 48341, United States
  • Research Site
    Roseville, Michigan 48066, United States
  • Research Site
    Kansas City, Missouri 64111, United States
  • Research Site
    Lincoln, Nebraska 68510, United States
  • Research Site
    Astoria, New York 11102, United States
  • Research Site
    Brooklyn, New York 11235, United States
  • Research Site
    Rosedale, New York 11422, United States
  • Research Site
    The Bronx, New York 10461, United States
  • Research Site
    Carrboro, North Carolina 27510, United States
  • Research Site
    Wilmington, North Carolina 28401, United States
  • Research Site
    Meadville, Pennsylvania 16335, United States
  • Research Site
    Philadelphia, Pennsylvania 19106, United States
  • Research Site
    Houston, Texas 77004, United States
  • Research Site
    Houston, Texas 77070, United States
  • Research Site
    San Antonio, Texas 78229, United States
  • Research Site
    Burlington, Vermont 05401, United States
  • Research Site
    Hampton, Virginia 23666, United States
  • Research Site
    Norfolk, Virginia 23502, United States
  • Research Site
    Toa Baja, 00949, Puerto Rico
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02253654
Lead sponsor
Amgen
Responsible party
Sponsor
First posted
Oct 1, 2014
Start date
Apr 1, 2015
Primary completion
Apr 27, 2016
Completion
May 25, 2016
Results posted
May 12, 2017
Last update
May 19, 2017

Study contacts

MD
study director · Amgen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Epoetin Alfa

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