Anemia, Erythrocyte Transfusion, Renal Dialysis, Renal Insufficiency, Chronic
Conditions
Keywords
Chronic Kidney Disease, Anemia, Hemodialysis, Red Blood Cell Transfusion
Brief 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.
Interventions
DRUGEpoetin alfa
Administered intravenously (IV) three times a week (TIW) by appropriately trained healthcare professionals during hemodialysis.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Hemoglobin Measurements Within 10 to 11 g/dL During the Evaluation Period | The evaluation period (weeks 13-37) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Transfusion Events Overall and During Each Study Period | 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 | The percentage of participants who received red blood cell (RBC) transfusions during the study and during each study period. |
| Hemoglobin Rate of Change at Each Visit | Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37 | 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. |
| Hemoglobin Intra-subject Variability | The evaluation period (weeks 13 to 37) | 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. |
| Hemoglobin Concentration at Each Visit | Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37 | — |
| Weekly Epoetin Alfa Dose at Each Visit | Weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35 | — |
| Number of RBC Units Transfused Overall and During Each Study Period | 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 | The number of red blood cell (RBC) units transfused during the study and during each study period. |
| Percentage of Participants With Hemoglobin Excursions at Each Visit | Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37 | 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. |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
This study was conducted at 31 centers in the United States. Participants were enrolled from 01 April 2015 to 17 August 2015.
Pre-assignment details
Eligible participants with anemia and chronic kidney disease who were receiving hemodialysis were randomized in a 1:1 ratio to 1 of 2 dosing algorithms.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 108 |
| 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. | 108 |
| Total | 216 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 4 | 7 |
| Overall Study | Decision by Sponsor | 1 | 1 |
| Overall Study | Did Not Receive Study Treatment | 4 | 1 |
| Overall Study | Lost to Follow-up | 2 | 5 |
| Overall Study | Withdrawal by Subject | 12 | 4 |
Baseline characteristics
| Characteristic | Epoetin Alfa Alternative Titration | Epoetin Alfa USPI Titration | Total |
|---|---|---|---|
| Age, Continuous | 60.9 years STANDARD_DEVIATION 13.3 | 58.7 years STANDARD_DEVIATION 14.2 | 59.8 years STANDARD_DEVIATION 1.8 |
| Race/Ethnicity, Customized Asian | 7 participants | 7 participants | 14 participants |
| Race/Ethnicity, Customized Black | 53 participants | 50 participants | 103 participants |
| Race/Ethnicity, Customized Hispanic/Latino | 30 participants | 39 participants | 69 participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Not Hispanic/Latino | 78 participants | 69 participants | 147 participants |
| Race/Ethnicity, Customized Other | 8 participants | 10 participants | 18 participants |
| Race/Ethnicity, Customized White | 40 participants | 40 participants | 80 participants |
| Sex: Female, Male Female | 48 Participants | 40 Participants | 88 Participants |
| Sex: Female, Male Male | 60 Participants | 68 Participants | 128 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 19 / 104 | 26 / 107 |
| serious Total, serious adverse events | 37 / 104 | 39 / 107 |
Outcome results
Primary
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)
Population: The Primary Analysis Set which consists of all randomized participants who had at least 6 hemoglobin measurements during the evaluation period while on study and receiving investigational product.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epoetin Alfa Alternative Titration | Percentage of Hemoglobin Measurements Within 10 to 11 g/dL During the Evaluation Period | 46.41 percentage of hemoglobin measurements | Standard Deviation 2.39 |
| Epoetin Alfa USPI Titration | Percentage of Hemoglobin Measurements Within 10 to 11 g/dL During the Evaluation Period | 46.02 percentage of hemoglobin measurements | Standard Deviation 2.56 |
Comparison: The difference between treatment groups for the percent of hemoglobin measurements within 10.0 to 11.0 g/dL during the evaluation period was tested using a 1-sided t-test with a significance level of 0.025.p-value: 0.46t-test, 1 sided
Secondary
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
Population: Primary analysis set with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Epoetin Alfa Alternative Titration | Hemoglobin Concentration at Each Visit | Week 3 (n = 89, 100) | 10.54 g/dL | Standard Deviation 0.88 |
| Epoetin Alfa Alternative Titration | Hemoglobin Concentration at Each Visit | Week 21 (n = 87, 99) | 10.33 g/dL | Standard Deviation 1.01 |
| Epoetin Alfa Alternative Titration | Hemoglobin Concentration at Each Visit | Week 9 (n = 89, 100) | 10.32 g/dL | Standard Deviation 1.16 |
| Epoetin Alfa Alternative Titration | Hemoglobin Concentration at Each Visit | Week 23 (n = 88, 98) | 10.46 g/dL | Standard Deviation 1.05 |
| Epoetin Alfa Alternative Titration | Hemoglobin Concentration at Each Visit | Baseline (n = 89, 100) | 10.15 g/dL | Standard Deviation 0.66 |
| Epoetin Alfa Alternative Titration | Hemoglobin Concentration at Each Visit | Week 25 (n = 87, 98) | 10.56 g/dL | Standard Deviation 1 |
| Epoetin Alfa Alternative Titration | Hemoglobin Concentration at Each Visit | Week 11 (n = 88, 99) | 10.33 g/dL | Standard Deviation 1.05 |
| Epoetin Alfa Alternative Titration | Hemoglobin Concentration at Each Visit | Week 27 (n = 88, 94) | 10.32 g/dL | Standard Deviation 1.1 |
| Epoetin Alfa Alternative Titration | Hemoglobin Concentration at Each Visit | Week 5 (n = 89, 99) | 10.66 g/dL | Standard Deviation 0.93 |
| Epoetin Alfa Alternative Titration | Hemoglobin Concentration at Each Visit | Week 29 (n =89, 92) | 10.34 g/dL | Standard Deviation 1.01 |
| Epoetin Alfa Alternative Titration | Hemoglobin Concentration at Each Visit | Week 15 (n = 89, 100) | 10.46 g/dL | Standard Deviation 1.38 |
| Epoetin Alfa Alternative Titration | Hemoglobin Concentration at Each Visit | Week 31 (n = 85, 89) | 10.34 g/dL | Standard Deviation 0.95 |
| Epoetin Alfa Alternative Titration | Hemoglobin Concentration at Each Visit | Week 13 (n = 89, 100) | 10.28 g/dL | Standard Deviation 1.04 |
| Epoetin Alfa Alternative Titration | Hemoglobin Concentration at Each Visit | Week 33 (n = 86, 90) | 10.18 g/dL | Standard Deviation 1 |
| Epoetin Alfa Alternative Titration | Hemoglobin Concentration at Each Visit | Week 17 (n = 89, 100) | 10.20 g/dL | Standard Deviation 1.05 |
| Epoetin Alfa Alternative Titration | Hemoglobin Concentration at Each Visit | Week 35 (n = 87, 88) | 10.12 g/dL | Standard Deviation 1.23 |
| Epoetin Alfa Alternative Titration | Hemoglobin Concentration at Each Visit | Week 7 (n = 88, 97) | 10.45 g/dL | Standard Deviation 1.02 |
| Epoetin Alfa Alternative Titration | Hemoglobin Concentration at Each Visit | Week 37 (n = 87, 93) | 10.10 g/dL | Standard Deviation 1.11 |
| Epoetin Alfa Alternative Titration | Hemoglobin Concentration at Each Visit | Week 19 (n = 89, 100) | 10.37 g/dL | Standard Deviation 1.14 |
| Epoetin Alfa USPI Titration | Hemoglobin Concentration at Each Visit | Week 37 (n = 87, 93) | 9.86 g/dL | Standard Deviation 0.85 |
| Epoetin Alfa USPI Titration | Hemoglobin Concentration at Each Visit | Baseline (n = 89, 100) | 10.04 g/dL | Standard Deviation 0.81 |
| Epoetin Alfa USPI Titration | Hemoglobin Concentration at Each Visit | Week 3 (n = 89, 100) | 10.34 g/dL | Standard Deviation 0.97 |
| Epoetin Alfa USPI Titration | Hemoglobin Concentration at Each Visit | Week 5 (n = 89, 99) | 10.51 g/dL | Standard Deviation 1.04 |
| Epoetin Alfa USPI Titration | Hemoglobin Concentration at Each Visit | Week 7 (n = 88, 97) | 10.28 g/dL | Standard Deviation 1.07 |
| Epoetin Alfa USPI Titration | Hemoglobin Concentration at Each Visit | Week 9 (n = 89, 100) | 9.97 g/dL | Standard Deviation 0.87 |
| Epoetin Alfa USPI Titration | Hemoglobin Concentration at Each Visit | Week 13 (n = 89, 100) | 9.99 g/dL | Standard Deviation 0.91 |
| Epoetin Alfa USPI Titration | Hemoglobin Concentration at Each Visit | Week 15 (n = 89, 100) | 9.98 g/dL | Standard Deviation 0.93 |
| Epoetin Alfa USPI Titration | Hemoglobin Concentration at Each Visit | Week 17 (n = 89, 100) | 10.01 g/dL | Standard Deviation 1.22 |
| Epoetin Alfa USPI Titration | Hemoglobin Concentration at Each Visit | Week 19 (n = 89, 100) | 9.94 g/dL | Standard Deviation 0.87 |
| Epoetin Alfa USPI Titration | Hemoglobin Concentration at Each Visit | Week 21 (n = 87, 99) | 9.92 g/dL | Standard Deviation 0.81 |
| Epoetin Alfa USPI Titration | Hemoglobin Concentration at Each Visit | Week 23 (n = 88, 98) | 10.03 g/dL | Standard Deviation 0.86 |
| Epoetin Alfa USPI Titration | Hemoglobin Concentration at Each Visit | Week 25 (n = 87, 98) | 9.94 g/dL | Standard Deviation 0.97 |
| Epoetin Alfa USPI Titration | Hemoglobin Concentration at Each Visit | Week 27 (n = 88, 94) | 9.97 g/dL | Standard Deviation 0.86 |
| Epoetin Alfa USPI Titration | Hemoglobin Concentration at Each Visit | Week 29 (n =89, 92) | 10.02 g/dL | Standard Deviation 1.07 |
| Epoetin Alfa USPI Titration | Hemoglobin Concentration at Each Visit | Week 31 (n = 85, 89) | 9.96 g/dL | Standard Deviation 1.07 |
| Epoetin Alfa USPI Titration | Hemoglobin Concentration at Each Visit | Week 33 (n = 86, 90) | 10.05 g/dL | Standard Deviation 0.92 |
| Epoetin Alfa USPI Titration | Hemoglobin Concentration at Each Visit | Week 35 (n = 87, 88) | 9.94 g/dL | Standard Deviation 0.9 |
| Epoetin Alfa USPI Titration | Hemoglobin Concentration at Each Visit | Week 11 (n = 88, 99) | 10.15 g/dL | Standard Deviation 0.88 |
Secondary
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)
Population: Primary analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epoetin Alfa Alternative Titration | Hemoglobin Intra-subject Variability | 0.74 g/dL | Standard Deviation 0.3 |
| Epoetin Alfa USPI Titration | Hemoglobin Intra-subject Variability | 0.70 g/dL | Standard Deviation 0.32 |
Secondary
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
Population: Primary analysis set with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Epoetin Alfa Alternative Titration | Hemoglobin Rate of Change at Each Visit | Week 3 (n = 89, 100) | 0.36 g/dL/2 weeks | Standard Deviation 0.79 |
| Epoetin Alfa Alternative Titration | Hemoglobin Rate of Change at Each Visit | Week 5 (n = 89, 99) | 0.10 g/dL/2 weeks | Standard Deviation 0.81 |
| Epoetin Alfa Alternative Titration | Hemoglobin Rate of Change at Each Visit | Week 7 (n = 88, 97) | -0.22 g/dL/2 weeks | Standard Deviation 0.9 |
| Epoetin Alfa Alternative Titration | Hemoglobin Rate of Change at Each Visit | Week 9 (n = 89, 100) | -0.12 g/dL/2 weeks | Standard Deviation 0.93 |
| Epoetin Alfa Alternative Titration | Hemoglobin Rate of Change at Each Visit | Week 11 (n = 88, 99) | 0.02 g/dL/2 weeks | Standard Deviation 1.01 |
| Epoetin Alfa Alternative Titration | Hemoglobin Rate of Change at Each Visit | Week 13 (n = 89, 100) | -0.05 g/dL/2 weeks | Standard Deviation 0.93 |
| Epoetin Alfa Alternative Titration | Hemoglobin Rate of Change at Each Visit | Week 15 (n = 89, 100) | 0.19 g/dL/2 weeks | Standard Deviation 1.01 |
| Epoetin Alfa Alternative Titration | Hemoglobin Rate of Change at Each Visit | Week 17 (n = 89, 100) | -0.22 g/dL/2 weeks | Standard Deviation 1.08 |
| Epoetin Alfa Alternative Titration | Hemoglobin Rate of Change at Each Visit | Week 19 (n = 89, 100) | 0.18 g/dL/2 weeks | Standard Deviation 0.97 |
| Epoetin Alfa Alternative Titration | Hemoglobin Rate of Change at Each Visit | Week 21 (n = 87, 99) | -0.02 g/dL/2 weeks | Standard Deviation 0.74 |
| Epoetin Alfa Alternative Titration | Hemoglobin Rate of Change at Each Visit | Week 23 (n = 88, 98) | 0.16 g/dL/2 weeks | Standard Deviation 0.87 |
| Epoetin Alfa Alternative Titration | Hemoglobin Rate of Change at Each Visit | Week 25 (n = 87, 98) | 0.07 g/dL/2 weeks | Standard Deviation 0.78 |
| Epoetin Alfa Alternative Titration | Hemoglobin Rate of Change at Each Visit | Week 27 (n = 88, 94) | -0.18 g/dL/2 weeks | Standard Deviation 0.77 |
| Epoetin Alfa Alternative Titration | Hemoglobin Rate of Change at Each Visit | Week 29 (n =89, 92) | 0.04 g/dL/2 weeks | Standard Deviation 0.86 |
| Epoetin Alfa Alternative Titration | Hemoglobin Rate of Change at Each Visit | Week 31 (n = 85, 89) | -0.02 g/dL/2 weeks | Standard Deviation 0.72 |
| Epoetin Alfa Alternative Titration | Hemoglobin Rate of Change at Each Visit | Week 33 (n = 86, 90) | -0.16 g/dL/2 weeks | Standard Deviation 0.82 |
| Epoetin Alfa Alternative Titration | Hemoglobin Rate of Change at Each Visit | Week 35 (n = 87, 88) | -0.05 g/dL/2 weeks | Standard Deviation 0.98 |
| Epoetin Alfa Alternative Titration | Hemoglobin Rate of Change at Each Visit | Week 37 (n = 87, 93) | -0.04 g/dL/2 weeks | Standard Deviation 1 |
| Epoetin Alfa USPI Titration | Hemoglobin Rate of Change at Each Visit | Week 29 (n =89, 92) | 0.05 g/dL/2 weeks | Standard Deviation 0.73 |
| Epoetin Alfa USPI Titration | Hemoglobin Rate of Change at Each Visit | Week 3 (n = 89, 100) | 0.27 g/dL/2 weeks | Standard Deviation 0.71 |
| Epoetin Alfa USPI Titration | Hemoglobin Rate of Change at Each Visit | Week 21 (n = 87, 99) | -0.06 g/dL/2 weeks | Standard Deviation 0.72 |
| Epoetin Alfa USPI Titration | Hemoglobin Rate of Change at Each Visit | Week 5 (n = 89, 99) | 0.13 g/dL/2 weeks | Standard Deviation 1.01 |
| Epoetin Alfa USPI Titration | Hemoglobin Rate of Change at Each Visit | Week 37 (n = 87, 93) | -0.03 g/dL/2 weeks | Standard Deviation 0.64 |
| Epoetin Alfa USPI Titration | Hemoglobin Rate of Change at Each Visit | Week 7 (n = 88, 97) | -0.19 g/dL/2 weeks | Standard Deviation 1.42 |
| Epoetin Alfa USPI Titration | Hemoglobin Rate of Change at Each Visit | Week 23 (n = 88, 98) | 0.09 g/dL/2 weeks | Standard Deviation 0.78 |
| Epoetin Alfa USPI Titration | Hemoglobin Rate of Change at Each Visit | Week 9 (n = 89, 100) | -0.28 g/dL/2 weeks | Standard Deviation 1.08 |
| Epoetin Alfa USPI Titration | Hemoglobin Rate of Change at Each Visit | Week 31 (n = 85, 89) | -0.03 g/dL/2 weeks | Standard Deviation 0.74 |
| Epoetin Alfa USPI Titration | Hemoglobin Rate of Change at Each Visit | Week 11 (n = 88, 99) | 0.19 g/dL/2 weeks | Standard Deviation 0.67 |
| Epoetin Alfa USPI Titration | Hemoglobin Rate of Change at Each Visit | Week 25 (n = 87, 98) | -0.06 g/dL/2 weeks | Standard Deviation 0.84 |
| Epoetin Alfa USPI Titration | Hemoglobin Rate of Change at Each Visit | Week 13 (n = 89, 100) | -0.19 g/dL/2 weeks | Standard Deviation 0.97 |
| Epoetin Alfa USPI Titration | Hemoglobin Rate of Change at Each Visit | Week 35 (n = 87, 88) | -0.13 g/dL/2 weeks | Standard Deviation 0.72 |
| Epoetin Alfa USPI Titration | Hemoglobin Rate of Change at Each Visit | Week 15 (n = 89, 100) | -0.01 g/dL/2 weeks | Standard Deviation 0.87 |
| Epoetin Alfa USPI Titration | Hemoglobin Rate of Change at Each Visit | Week 27 (n = 88, 94) | 0.01 g/dL/2 weeks | Standard Deviation 0.85 |
| Epoetin Alfa USPI Titration | Hemoglobin Rate of Change at Each Visit | Week 17 (n = 89, 100) | 0.02 g/dL/2 weeks | Standard Deviation 1.07 |
| Epoetin Alfa USPI Titration | Hemoglobin Rate of Change at Each Visit | Week 33 (n = 86, 90) | 0.06 g/dL/2 weeks | Standard Deviation 0.74 |
| Epoetin Alfa USPI Titration | Hemoglobin Rate of Change at Each Visit | Week 19 (n = 89, 100) | -0.06 g/dL/2 weeks | Standard Deviation 1.25 |
Secondary
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
Population: Primary analysis set with available data in each study period
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Epoetin Alfa Alternative Titration | Number of RBC Units Transfused Overall and During Each Study Period | Overall Study: 1 RBC Unit (n = 89, 100) | 1 participants |
| Epoetin Alfa Alternative Titration | Number of RBC Units Transfused Overall and During Each Study Period | Overall Study: 2 RBC Units (n = 89, 100) | 2 participants |
| Epoetin Alfa Alternative Titration | Number of RBC Units Transfused Overall and During Each Study Period | Overall Study: 3 RBC Units (n = 89, 100) | 1 participants |
| Epoetin Alfa Alternative Titration | Number of RBC Units Transfused Overall and During Each Study Period | Overall Study: > 3 RBC Units (n = 89, 100) | 2 participants |
| Epoetin Alfa Alternative Titration | Number of RBC Units Transfused Overall and During Each Study Period | Titration Period: 1 RBC Unit (n = 89, 100) | 0 participants |
| Epoetin Alfa Alternative Titration | Number of RBC Units Transfused Overall and During Each Study Period | Titration Period: 2 RBC Units (n = 89, 100) | 1 participants |
| Epoetin Alfa Alternative Titration | Number of RBC Units Transfused Overall and During Each Study Period | Titration Period: 3 RBC Units (n = 89, 100) | 1 participants |
| Epoetin Alfa Alternative Titration | Number of RBC Units Transfused Overall and During Each Study Period | Titration Period: > 3 RBC Units (n = 89, 100) | 0 participants |
| Epoetin Alfa Alternative Titration | Number of RBC Units Transfused Overall and During Each Study Period | Evaluation Period: 1 RBC Unit (n = 89, 100) | 1 participants |
| Epoetin Alfa Alternative Titration | Number of RBC Units Transfused Overall and During Each Study Period | Evaluation Period: 2 RBC Units (n = 89, 100) | 3 participants |
| Epoetin Alfa Alternative Titration | Number of RBC Units Transfused Overall and During Each Study Period | Evaluation Period: 3 RBC Units (n = 89, 100) | 1 participants |
| Epoetin Alfa Alternative Titration | Number of RBC Units Transfused Overall and During Each Study Period | Evaluation Period: > 3 RBC Units (n = 89, 100) | 0 participants |
| Epoetin Alfa Alternative Titration | Number of RBC Units Transfused Overall and During Each Study Period | Safety Follow-up Period: 1 RBC Unit (n = 83, 90) | 0 participants |
| Epoetin Alfa Alternative Titration | Number of RBC Units Transfused Overall and During Each Study Period | Safety Follow-up Period: 2 RBC Units (n = 83, 90) | 1 participants |
| Epoetin Alfa Alternative Titration | Number of RBC Units Transfused Overall and During Each Study Period | Safety Follow-up Period: 3 RBC Units (n = 83, 90) | 0 participants |
| Epoetin Alfa Alternative Titration | Number of RBC Units Transfused Overall and During Each Study Period | Safety Follow-up Period: >3 RBC Units (n = 83, 90) | 0 participants |
| Epoetin Alfa USPI Titration | Number of RBC Units Transfused Overall and During Each Study Period | Safety Follow-up Period: >3 RBC Units (n = 83, 90) | 0 participants |
| Epoetin Alfa USPI Titration | Number of RBC Units Transfused Overall and During Each Study Period | Overall Study: 1 RBC Unit (n = 89, 100) | 4 participants |
| Epoetin Alfa USPI Titration | Number of RBC Units Transfused Overall and During Each Study Period | Evaluation Period: 1 RBC Unit (n = 89, 100) | 3 participants |
| Epoetin Alfa USPI Titration | Number of RBC Units Transfused Overall and During Each Study Period | Overall Study: 2 RBC Units (n = 89, 100) | 5 participants |
| Epoetin Alfa USPI Titration | Number of RBC Units Transfused Overall and During Each Study Period | Safety Follow-up Period: 1 RBC Unit (n = 83, 90) | 0 participants |
| Epoetin Alfa USPI Titration | Number of RBC Units Transfused Overall and During Each Study Period | Overall Study: 3 RBC Units (n = 89, 100) | 2 participants |
| Epoetin Alfa USPI Titration | Number of RBC Units Transfused Overall and During Each Study Period | Evaluation Period: 2 RBC Units (n = 89, 100) | 4 participants |
| Epoetin Alfa USPI Titration | Number of RBC Units Transfused Overall and During Each Study Period | Overall Study: > 3 RBC Units (n = 89, 100) | 1 participants |
| Epoetin Alfa USPI Titration | Number of RBC Units Transfused Overall and During Each Study Period | Safety Follow-up Period: 3 RBC Units (n = 83, 90) | 0 participants |
| Epoetin Alfa USPI Titration | Number of RBC Units Transfused Overall and During Each Study Period | Titration Period: 1 RBC Unit (n = 89, 100) | 1 participants |
| Epoetin Alfa USPI Titration | Number of RBC Units Transfused Overall and During Each Study Period | Evaluation Period: 3 RBC Units (n = 89, 100) | 2 participants |
| Epoetin Alfa USPI Titration | Number of RBC Units Transfused Overall and During Each Study Period | Titration Period: 2 RBC Units (n = 89, 100) | 0 participants |
| Epoetin Alfa USPI Titration | Number of RBC Units Transfused Overall and During Each Study Period | Safety Follow-up Period: 2 RBC Units (n = 83, 90) | 1 participants |
| Epoetin Alfa USPI Titration | Number of RBC Units Transfused Overall and During Each Study Period | Titration Period: 3 RBC Units (n = 89, 100) | 0 participants |
| Epoetin Alfa USPI Titration | Number of RBC Units Transfused Overall and During Each Study Period | Evaluation Period: > 3 RBC Units (n = 89, 100) | 1 participants |
| Epoetin Alfa USPI Titration | Number of RBC Units Transfused Overall and During Each Study Period | Titration Period: > 3 RBC Units (n = 89, 100) | 0 participants |
Secondary
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
Population: Primary analysis set with available data at each time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 7 Excursions < 9.0 (n = 88, 97) | 6.8 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 21 Excursions < 9.0 (n = 87, 99) | 8.0 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 21 Excursions > 11.0 (n = 87, 99) | 19.5 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 31 Excursions > 11.0 (n = 85, 89) | 15.3 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Overall Excursions (n = 89, 100) | 91.0 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Overall Excursions < 9.0 (n = 89, 100) | 48.3 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Overall Excursions > 11.0 (n = 89, 100) | 80.9 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Overall Excursions > 12.0 (n = 89, 100) | 25.8 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Baseline Excursions (n = 89, 100) | 3.4 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Baseline Excursions < 9.0 (n = 89, 100) | 3.4 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Baseline Excursions > 11.0 (n = 89, 100) | 0.0 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Baseline Excursions > 12.0 (n = 89, 100) | 0.0 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 3 Excursions (n = 89, 100) | 29.2 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 3 Excursions < 9.0 (n = 89, 100) | 2.2 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 3 Excursions > 11.0 (n = 89, 100) | 27.0 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 3 Excursions > 12.0 (n = 89, 100) | 5.6 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 5 Excursions (n = 89, 99) | 36.0 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 5 Excursions < 9.0 (n = 89, 99) | 1.1 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 5 Excursions > 11.0 (n = 89, 99) | 34.8 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 5 Excursions > 12.0 (n = 89, 99) | 5.6 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 7 Excursions (n = 88, 97) | 27.3 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 7 Excursions > 11.0 (n = 88, 97) | 20.5 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 7 Excursions > 12.0 (n = 88, 97) | 3.4 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 9 Excursions (n = 89, 100) | 29.2 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 9 Excursions < 9.0 (n = 89, 100) | 9.0 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 9 Excursions > 11.0 (n = 89, 100) | 20.2 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 9 Excursions > 12.0 (n = 89, 100) | 3.4 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 11 Excursions (n = 88, 99) | 22.7 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 11 Excursions < 9.0 (n = 88, 99) | 4.5 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 11 Excursions > 11.0 (n = 88, 99) | 18.2 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 11 Excursions > 12.0 (n = 88, 99) | 2.3 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 13 Excursions (n = 89, 100) | 25.8 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 13 Excursions < 9.0 (n = 89, 100) | 7.9 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 13 Excursions > 11.0 (n = 89, 100) | 18.0 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 13 Excursions > 12.0 (n = 89, 100) | 4.5 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 15 Excursions (n = 89, 100) | 27.0 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 15 Excursions < 9.0 (n = 89, 100) | 5.6 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 15 Excursions > 11.0 (n = 89, 100) | 21.3 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 15 Excursions > 12.0 (n = 89, 100) | 6.7 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 17 Excursions (n = 89, 100) | 23.6 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 17 Excursions < 9.0 (n = 89, 100) | 9.0 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 17 Excursions > 11.0 (n = 89, 100) | 14.6 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 17 Excursions > 12.0 (n = 89, 100) | 4.5 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 19 Excursions (n = 89, 100) | 28.1 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 19 Excursions < 9.0 (n = 89, 100) | 9.0 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 19 Excursions > 11.0 (n = 89, 100) | 19.1 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 19 Excursions > 12.0 (n = 89, 100) | 9.0 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 21 Excursions (n = 87, 99) | 27.6 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 21 Excursions > 12.0 (n = 87, 99) | 3.4 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 23 Excursions (n = 88, 98) | 29.5 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 23 Excursions < 9.0 (n = 88, 98) | 6.8 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 23 Excursions > 11.0 (n = 88, 98) | 22.7 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 23 Excursions > 12.0 (n = 88, 98) | 5.7 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 25 Excursions (n = 87, 98) | 28.7 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 25 Excursions < 9.0 (n = 87, 98) | 2.3 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 25 Excursions > 11.0 (n = 87, 98) | 26.4 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 25 Excursions > 12.0 (n = 87, 98) | 5.7 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 27 Excursions (n = 88, 94) | 29.5 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 27 Excursions < 9.0 (n = 88, 94) | 10.2 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 27 Excursions > 11.0 (n = 88, 94) | 19.3 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 27 Excursions > 12.0 (n = 88, 94) | 3.4 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 29 Excursions (n = 89, 92) | 25.8 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 29 Excursions < 9.0 (n = 89, 92) | 5.6 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 29 Excursions > 11.0 (n = 89, 92) | 20.2 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 29 Excursions > 12.0 (n = 89, 92) | 4.5 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 31 Excursions (n = 85, 89) | 20.0 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 31 Excursions < 9.0 (n = 85, 89) | 4.7 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 31 Excursions > 12.0 (n = 85, 89) | 5.9 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 33 Excursions (n = 86, 90) | 22.1 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 33 Excursions < 9.0 (n = 86, 90) | 7.0 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 33 Excursions > 11.0 (n = 86, 90) | 15.1 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 33 Excursions > 12.0 (n = 86, 90) | 3.5 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 35 Excursions (n = 87, 88) | 26.4 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 35 Excursions < 9.0 (n = 87, 88) | 11.5 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 35 Excursions > 11.0 (n = 87, 88) | 14.9 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 35 Excursions > 12.0 (n = 87, 88) | 4.6 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 37 Excursions (n = 87, 93) | 20.7 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 37 Excursions < 9.0 (n = 87, 93) | 8.0 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 37 Excursions > 11.0 (n = 87, 93) | 12.6 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 37 Excursions > 12.0 (n = 87, 93) | 3.4 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 27 Excursions > 12.0 (n = 88, 94) | 0.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 21 Excursions (n = 87, 99) | 17.2 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 33 Excursions > 11.0 (n = 86, 90) | 11.1 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 21 Excursions < 9.0 (n = 87, 99) | 12.1 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 17 Excursions > 11.0 (n = 89, 100) | 9.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 29 Excursions (n = 89, 92) | 29.3 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 17 Excursions > 12.0 (n = 89, 100) | 3.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Overall Excursions (n = 89, 100) | 93.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 35 Excursions > 12.0 (n = 87, 88) | 0.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Overall Excursions < 9.0 (n = 89, 100) | 61.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 19 Excursions (n = 89, 100) | 19.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Overall Excursions > 11.0 (n = 89, 100) | 83.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 29 Excursions < 9.0 (n = 89, 92) | 16.3 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Overall Excursions > 12.0 (n = 89, 100) | 19.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 19 Excursions < 9.0 (n = 89, 100) | 13.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Baseline Excursions (n = 89, 100) | 11.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 33 Excursions > 12.0 (n = 86, 90) | 2.2 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Baseline Excursions < 9.0 (n = 89, 100) | 11.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 19 Excursions > 11.0 (n = 89, 100) | 6.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Baseline Excursions > 11.0 (n = 89, 100) | 0.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 29 Excursions > 11.0 (n = 89, 92) | 13.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Baseline Excursions > 12.0 (n = 89, 100) | 0.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 19 Excursions > 12.0 (n = 89, 100) | 0.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 3 Excursions (n = 89, 100) | 27.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 37 Excursions > 12.0 (n = 87, 93) | 0.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 3 Excursions < 9.0 (n = 89, 100) | 6.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 21 Excursions > 11.0 (n = 87, 99) | 5.1 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 3 Excursions > 11.0 (n = 89, 100) | 21.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 29 Excursions > 12.0 (n = 89, 92) | 2.2 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 3 Excursions > 12.0 (n = 89, 100) | 5.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 21 Excursions > 12.0 (n = 87, 99) | 0.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 5 Excursions (n = 89, 99) | 29.3 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 35 Excursions (n = 87, 88) | 21.6 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 5 Excursions < 9.0 (n = 89, 99) | 4.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 23 Excursions (n = 88, 98) | 20.4 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 5 Excursions > 11.0 (n = 89, 99) | 25.3 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 31 Excursions (n = 85, 89) | 28.1 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 5 Excursions > 12.0 (n = 89, 99) | 7.1 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 23 Excursions < 9.0 (n = 88, 98) | 10.2 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 7 Excursions (n = 88, 97) | 28.9 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 17 Excursions < 9.0 (n = 89, 100) | 12.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 7 Excursions < 9.0 (n = 88, 97) | 8.2 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 37 Excursions (n = 87, 93) | 17.2 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 7 Excursions > 11.0 (n = 88, 97) | 20.6 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 23 Excursions > 11.0 (n = 88, 98) | 10.2 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 7 Excursions > 12.0 (n = 88, 97) | 4.1 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 31 Excursions < 9.0 (n = 85, 89) | 16.9 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 9 Excursions (n = 89, 100) | 17.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 23 Excursions > 12.0 (n = 88, 98) | 0.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 9 Excursions < 9.0 (n = 89, 100) | 10.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 31 Excursions > 11.0 (n = 85, 89) | 11.2 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 9 Excursions > 11.0 (n = 89, 100) | 7.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 25 Excursions (n = 87, 98) | 20.4 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 9 Excursions > 12.0 (n = 89, 100) | 0.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 35 Excursions < 9.0 (n = 87, 88) | 13.6 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 11 Excursions (n = 88, 99) | 23.2 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 25 Excursions < 9.0 (n = 87, 98) | 13.3 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 11 Excursions < 9.0 (n = 88, 99) | 7.1 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 31 Excursions > 12.0 (n = 85, 89) | 1.1 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 11 Excursions > 11.0 (n = 88, 99) | 16.2 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 25 Excursions > 11.0 (n = 87, 98) | 7.1 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 11 Excursions > 12.0 (n = 88, 99) | 1.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 37 Excursions > 11.0 (n = 87, 93) | 4.3 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 13 Excursions (n = 89, 100) | 21.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 25 Excursions > 12.0 (n = 87, 98) | 2.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 13 Excursions < 9.0 (n = 89, 100) | 9.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 33 Excursions (n = 86, 90) | 22.2 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 13 Excursions > 11.0 (n = 89, 100) | 12.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 27 Excursions (n = 88, 94) | 21.3 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 13 Excursions > 12.0 (n = 89, 100) | 1.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 35 Excursions > 11.0 (n = 87, 88) | 8.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 15 Excursions (n = 89, 100) | 24.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 27 Excursions < 9.0 (n = 88, 94) | 16.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 15 Excursions < 9.0 (n = 89, 100) | 13.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 33 Excursions < 9.0 (n = 86, 90) | 11.1 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 15 Excursions > 11.0 (n = 89, 100) | 11.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 27 Excursions > 11.0 (n = 88, 94) | 5.3 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 15 Excursions > 12.0 (n = 89, 100) | 0.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 37 Excursions < 9.0 (n = 87, 93) | 12.9 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Hemoglobin Excursions at Each Visit | Week 17 Excursions (n = 89, 100) | 21.0 percentage of participants |
Secondary
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
Population: Primary analysis set with available data in each study period
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Epoetin Alfa Alternative Titration | Percentage of Participants With Transfusion Events Overall and During Each Study Period | Overall (n = 89, 100) | 6.7 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Transfusion Events Overall and During Each Study Period | Titration Period (n = 89, 100) | 2.2 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Transfusion Events Overall and During Each Study Period | Evaluation Period (n = 89, 100) | 5.6 percentage of participants |
| Epoetin Alfa Alternative Titration | Percentage of Participants With Transfusion Events Overall and During Each Study Period | Safety Follow-up Period (n = 83, 90) | 1.2 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Transfusion Events Overall and During Each Study Period | Safety Follow-up Period (n = 83, 90) | 1.1 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Transfusion Events Overall and During Each Study Period | Overall (n = 89, 100) | 12.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Transfusion Events Overall and During Each Study Period | Evaluation Period (n = 89, 100) | 10.0 percentage of participants |
| Epoetin Alfa USPI Titration | Percentage of Participants With Transfusion Events Overall and During Each Study Period | Titration Period (n = 89, 100) | 1.0 percentage of participants |
Secondary
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
Population: Primary analysis set with available data at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Epoetin Alfa Alternative Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 1 (n = 89, 100) | 13139.9 units | Standard Deviation 9360.1 |
| Epoetin Alfa Alternative Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 3 (n = 89, 100) | 9683.7 units | Standard Deviation 9162.9 |
| Epoetin Alfa Alternative Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 5 (n = 89, 100) | 8324.2 units | Standard Deviation 8689.7 |
| Epoetin Alfa Alternative Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 7 (n = 89, 100) | 9319.1 units | Standard Deviation 7977.5 |
| Epoetin Alfa Alternative Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 9 (n = 89, 100) | 9253.4 units | Standard Deviation 8536.9 |
| Epoetin Alfa Alternative Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 11 (n = 89, 100) | 10039.3 units | Standard Deviation 9194.1 |
| Epoetin Alfa Alternative Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 13 (n = 89, 100) | 10358.4 units | Standard Deviation 10247.7 |
| Epoetin Alfa Alternative Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 15 (n = 89, 100) | 8889.3 units | Standard Deviation 8316.8 |
| Epoetin Alfa Alternative Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 17 (n = 89, 100) | 10251.7 units | Standard Deviation 9973.7 |
| Epoetin Alfa Alternative Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 19 (n = 89, 100) | 10475.8 units | Standard Deviation 10437 |
| Epoetin Alfa Alternative Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 21 (n = 89, 99) | 9605.1 units | Standard Deviation 8225 |
| Epoetin Alfa Alternative Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 23 (n = 89, 98) | 8905.1 units | Standard Deviation 7748.3 |
| Epoetin Alfa Alternative Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 25 (n = 89, 98) | 7543.8 units | Standard Deviation 7225.1 |
| Epoetin Alfa Alternative Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 27 (n = 89, 96) | 9765.7 units | Standard Deviation 12013.7 |
| Epoetin Alfa Alternative Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 29 (n =89, 94) | 9088.8 units | Standard Deviation 10146.9 |
| Epoetin Alfa Alternative Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 31 (n = 88, 91) | 8543.2 units | Standard Deviation 10821.7 |
| Epoetin Alfa Alternative Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 33 (n = 87, 90) | 9019.0 units | Standard Deviation 10466.9 |
| Epoetin Alfa Alternative Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 35 (n = 87, 90) | 8709.2 units | Standard Deviation 8631.9 |
| Epoetin Alfa USPI Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 27 (n = 89, 96) | 6662.5 units | Standard Deviation 6362.8 |
| Epoetin Alfa USPI Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 1 (n = 89, 100) | 10400 units | Standard Deviation 8439.9 |
| Epoetin Alfa USPI Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 19 (n = 89, 100) | 7112.5 units | Standard Deviation 6300.4 |
| Epoetin Alfa USPI Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 3 (n = 89, 100) | 6912.5 units | Standard Deviation 7459.4 |
| Epoetin Alfa USPI Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 35 (n = 87, 90) | 5950.6 units | Standard Deviation 5364.6 |
| Epoetin Alfa USPI Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 5 (n = 89, 100) | 6874.0 units | Standard Deviation 8204.3 |
| Epoetin Alfa USPI Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 21 (n = 89, 99) | 6909.6 units | Standard Deviation 6102.5 |
| Epoetin Alfa USPI Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 7 (n = 89, 100) | 6411.0 units | Standard Deviation 7040.6 |
| Epoetin Alfa USPI Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 29 (n =89, 94) | 6083.0 units | Standard Deviation 6149.1 |
| Epoetin Alfa USPI Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 9 (n = 89, 100) | 8003.0 units | Standard Deviation 7292.8 |
| Epoetin Alfa USPI Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 23 (n = 89, 98) | 6830.1 units | Standard Deviation 6397 |
| Epoetin Alfa USPI Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 11 (n = 89, 100) | 6483.0 units | Standard Deviation 6854.9 |
| Epoetin Alfa USPI Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 33 (n = 87, 90) | 6235.6 units | Standard Deviation 6041.6 |
| Epoetin Alfa USPI Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 13 (n = 89, 100) | 7387.5 units | Standard Deviation 7271.6 |
| Epoetin Alfa USPI Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 25 (n = 89, 98) | 7486.7 units | Standard Deviation 6676.2 |
| Epoetin Alfa USPI Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 15 (n = 89, 100) | 6874.5 units | Standard Deviation 5952.9 |
| Epoetin Alfa USPI Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 31 (n = 88, 91) | 6673.1 units | Standard Deviation 6277.6 |
| Epoetin Alfa USPI Titration | Weekly Epoetin Alfa Dose at Each Visit | Week 17 (n = 89, 100) | 6924.5 units | Standard Deviation 6211.1 |