Chronic Kidney Disease, Chronic Renal Failure
Conditions
Brief summary
The purpose of this study is to demonstrate therapeutic equivalence of IV Epoetin Hospira compared to IV Epogen (Amgen), based on maintenance of Hb levels and study drug dose requirements in patients treated for anemia associated with chronic renal failure and on hemodialysis.
Interventions
BIOLOGICALEpoetin Hospira
Variable dose
BIOLOGICALEpogen (Amgen)
Variable dose
Sponsors
Hospira, now a wholly owned subsidiary of Pfizer
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patient is able to provide written informed consent after risks and benefits of the study have been explained prior to any study related activities 2. Hemodialysis patients with chronic renal failure and renal anemia currently on stable Epogen (Amgen) treatment for at least 4 weeks prior to randomization, for whom the following apply (during this period): * Epogen (Amgen) dose has been administered intravenously 1 to 3 times per week with no more than a 10% dose change from the mean for at least 4 weeks prior to randomization * Stable hemoglobin, defined as meeting all of the following: * Mean hemoglobin during the 4 weeks prior to randomization between 9.0 and 11.0 g/dL * No more than one hemoglobin outside of range from 9.0-11.0 g/dL during the 4 weeks prior to randomization * No hemoglobin result more than ±1 g/dL from the mean hemoglobin level during the 4 week period prior to randomization 3. Patients on stable, adequate dialysis for at least 12 weeks prior to randomization, defined as no clinically relevant changes of dialysis regimen and/or dialyzer 4. Patients with adequate iron stores, defined as ferritin \>100 μg/L and TSAT \>20%, prior to randomization 5. Male or female patients aged 18 to 80 years (both inclusive) 6. If female, patient must be either postmenopausal for at least 1 year prior to randomization, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or practicing at least 1 of the following methods of birth control: * hormonal contraceptives (oral, parenteral, or transdermal) for at least 3 months prior to randomization * intrauterine device (IUD) * double-barrier method (condoms, contraceptive sponge, diaphragm, or vaginal ring with spermicidal jellies or cream) If hormonal contraceptives are used, the specific contraceptive must have been used for at least 3 months prior to randomization. If the patient is currently using a hormonal contraceptive, she should also use a barrier method during this study and for at least 30 days following the administration of the patient's last dose
Exclusion criteria
1. Maintenance Epoetin dosage \>600 U/kg per week (1-3 times per week) 2. Treatment with long-acting epoetin analogues such as Aranesp ® within 3 months prior to randomization 3. Any of the following within 3 months prior to randomization: * Myocardial infarction * Stroke (cerebrovascular accident)/cerebrovascular insult (minor stroke) or transient ischemic attack/intracerebral bleeding/cerebral infarction * Severe/unstable angina * Coronary angioplasty, bypass surgery, or peripheral artery bypass graft * Decompensated congestive heart failure (New York Heart Association \[NYHA\] class IV) * Pulmonary embolism * Deep vein thrombosis or other thromboembolic event * Received live or attenuated vaccination (except flu vaccination) 4. Uncontrolled Hypertension within the 4 weeks prior to randomization, defined as more than 10% of post-dialysis blood pressures \>170 mmHg systolic and/or \>110 mmHg diastolic, based on blood pressure readings obtained when the patient's post-dialysis body weight was not more than 0.5 kg above their listed dry weight 5. Known, clinically manifested deficiency of folic acid and/or vitamin B12 (irrespective of whether currently treated or not) 6. A patient with any active, uncontrolled systemic, inflammatory or malignant disease (including demyelinating diseases such as multiple sclerosis) that in the Investigator's opinion may be significant to exclude participation in the study, including but not limited to microbial, viral, or fungal infection or mental disease 7. Contraindication for the test drug or have been previously treated with Epoetin Hospira 8. Relative or absolute iron deficiency prior to randomization 9. Platelet count below 100 x 10\^9/L 10. Clinically relevant increase of CRP (\>10 mg/dL) for at least 2 weeks 11. Significant drug sensitivity or a significant allergic reaction to any drug, as well as known hypersensitivity or idiosyncratic reaction to epoetin (or its excipients, including albumin) or any other related drugs that in the judgment of the Investigator is exclusionary for the study participation 12. History of any of the following: * Detectable anti- rhEPO antibodies * Clinically relevant malnutrition * Confirmed aluminum intoxication * Myelodysplastic syndrome * Known bone marrow fibrosis (osteitis fibrosa cystica) * Known seizure disorder * Liver cirrhosis with clinical evidence of complications (portal hypertension, splenomegaly, ascites) 13. A female patient who is pregnant, lactating or planning a pregnancy during the study 14. History of drug abuse or alcohol abuse within 2 years prior to randomization as determined by the Investigator 15. Current participation or participation in a drug or other investigational research study within 30 days prior to randomization 16. May not be able to comply with the requirements of this clinical study, communicate effectively with study personnel, or is considered by the Investigator, for any reason, to be an unsuitable candidate for the study 17. Donated or lost \>475 mL (i.e., 1 pint) blood volume (including plasmapheresis) or had a transfusion of any blood product within 3 months prior to randomization 18. A patient who in the Investigator's opinion, has any clinically significant abnormal laboratory evaluations, including liver function taken at Screening Visit 19. Positive laboratory test for human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Weekly Hemoglobin Level From Week 21 to Week 24 | Week 21 up to Week 24 |
| Mean Weekly Dosage of Study Medication From Week 21 to Week 24 | Week 21 up to Week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Weekly Dosage of Study Medication Through 24 Weeks | Week 1 up to Week 24 | — |
| Mean Weekly Hemoglobin Level Through 24 Weeks | Week 1 up to Week 24 | — |
| Total Dose of Study Medication Administered | Week 1 up to Week 24 | — |
| Percentage of Participants With Mean Weekly Hemoglobin Level Within the Target Range | Week 12, 24 | Percentage of participants who had hemoglobin level within the target range of 9 to 11 g/dL for the specified weeks were reported. |
| Percentage of Participants Who Required Permanent Dose Changes of Study Medication | Week 1 up to Week 24 | — |
| Percentage of Participants Who Required Temporary Dose Changes of Study Medication | Week 1 up to Week 24 | — |
| Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 1 Gram Per Deciliter (g/dL) | Week 1 up to Week 24 | — |
| Percentage of Participants With Mean Weekly Hemoglobin Level Outside the Target Range | Week 12, 24 | Percentage of participants who had hemoglobin level outside the target range of 9 to 11 g/dL for the specified weeks were reported. |
| Percentage of Participants Who Received Blood Transfusions | Week 1 up to Week 24 | — |
| Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level | Week 1 up to Week 24 | In this outcome measure number of participants with change (increase and decrease) in mean dose of Epoetin Hospira and Epogen were categorized and reported according to their mean hemoglobin levels. Hemoglobin levels were divided in following classes: \>11.0 g/dL, from 9.0 to 11.0 g/dL and \<9.0 g/dL |
| Percentage of Participants With Any Transient Change of Hemoglobin Greater Than (>) 2.0 Gram Per Deciliter (g/dL) in Hemoglobin Level | Week 1 up to Week 24 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL) | Week 1 up to Week 24 | — |
| Number of Participants With Treatment-Emergent Adverse Events by Severity | Week 1 up to Week 28 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug to the end of study (up to Week 28) that were absent before treatment or that worsened relative to pre-treatment state. An AE was assessed according to severity; mild (AE was transient and easily tolerated by the participant), moderate (caused problem that did not interfere significantly with usual activities) and severe (caused problem that interferes significantly with usual activities and might be incapacitating or life-threatening). |
| Number of Participants With Treatment Related Adverse Events (AEs) | Week 1 up to Week 28 | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. |
| Number of Participants That Discontinued Treatment Due to a Treatment Emergent Adverse Event | Week 1 up to Week 28 | In this outcome measure number of participants who discontinued from study drug (Epoetin Hospira, Epogen) due to any AE were reported. |
| Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters | Baseline up to Week 28 | Laboratory parameters: Hematology (hematocrit, hemoglobin, red blood cell count, reticulocytes, white blood cell count, neutrophils, bands, lymphocytes, monocytes, basophils, eosinophils, platelet count, mean corpuscular volume); coagulation panel (prothrombin time, international normalized ratio, activated partial thromboplastin time); clinical chemistry (blood urea nitrogen, creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, gamma-glutamyl transpeptidase, alkaline phosphatase, sodium, potassium, calcium, magnesium, phosphorus, uric acid, total protein, glucose, albumin, C-reactive protein, plasma ferritin, transferrin saturation). Participants with clinically significant change from baseline in laboratory parameters were as determined by the investigator. |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Baseline up to Week 28 | Vital sign parameters: temperature (oral, tympanic, or other), blood pressure (diastolic and systolic), heart rate (in a seated position) and dry weight (post-dialysis). Participants with clinically significant change from baseline in vital signs were as determined by the investigator. |
| Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) | Baseline up to Week 28 | ECG parameters: PR interval, QRS complex, QT interval and QTC interval. Participants with clinically significant change from baseline in ECG were as determined by the investigator. |
| Number of Participants With Clinically Significant Change From Baseline in Physical Examination | Baseline up to Week 28 | Physical examination included examination of the following: skin, eyes, ears, throat, cardiac, respiratory, gastrointestinal, genitourinary and musculoskeletal systems. Participants with clinically significant change from baseline in physical examination were as determined by the investigator. |
| Percentage of Participants With Anti-Recombinant Human Erythropoietin (Anti-rhEPO) Antibodies | Week 1 up to Week 28 | Percentage of participants with presence of anti-rhEPO antibodies were reported in this outcome measure. Radioimmunoprecipitation assay method was used to determine the presence of anti-rhEPO antibodies. |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Week 1 up to Week 28 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged in-patient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events from first dose of study drug to the end of study (up to Week 28) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events. |
| Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL) | Week 1 up to Week 24 | — |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
Participants with chronic renal failure were receiving Epoetin maintenance therapy prior to enrollment and treatment in this study.
Participants by arm
| Arm | Count |
|---|---|
| Epoetin Hospira Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28. | 306 |
| Epogen Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28. | 306 |
| Total | 612 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 8 | 8 |
| Overall Study | Elevated Hemoglobin | 1 | 0 |
| Overall Study | Kidney Transplant | 7 | 6 |
| Overall Study | Lost to Follow-up | 10 | 4 |
| Overall Study | Patient Lost Green Card Status | 1 | 0 |
| Overall Study | Patient Received Aranesp | 1 | 0 |
| Overall Study | Physician Decision | 1 | 4 |
| Overall Study | Randomization Error | 3 | 1 |
| Overall Study | Site Closure | 1 | 0 |
| Overall Study | Sponsor's Decision | 10 | 10 |
| Overall Study | Temperature Excursion | 2 | 3 |
| Overall Study | Transfer to Another Facility/Unit | 4 | 3 |
| Overall Study | Vacation/Travel | 1 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 7 |
Baseline characteristics
| Characteristic | Epoetin Hospira | Epogen | Total |
|---|---|---|---|
| Age, Continuous | 55.32 years STANDARD_DEVIATION 13.057 | 57.35 years STANDARD_DEVIATION 11.44 | 56.34 years STANDARD_DEVIATION 12.307 |
| Sex: Female, Male Female | 146 Participants | 131 Participants | 277 Participants |
| Sex: Female, Male Male | 160 Participants | 175 Participants | 335 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 143 / 301 | 141 / 304 |
| serious Total, serious adverse events | 75 / 301 | 82 / 304 |
Outcome results
Primary
Mean Weekly Dosage of Study Medication From Week 21 to Week 24
Time frame: Week 21 up to Week 24
Population: ITT population included all participants who were randomized to study treatment. Here, Number of Participants Analyzed (N) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epoetin Hospira | Mean Weekly Dosage of Study Medication From Week 21 to Week 24 | 89.61 unit per kilogram per week (U/kg/week) | Standard Deviation 99.824 |
| Epogen | Mean Weekly Dosage of Study Medication From Week 21 to Week 24 | 90.37 unit per kilogram per week (U/kg/week) | Standard Deviation 88.492 |
Comparison: LS mean and 95 percent CI were derived from an ANCOVA model with fixed effect of treatment.95% CI: [-10.4, 11.13]
Primary
Mean Weekly Hemoglobin Level From Week 21 to Week 24
Time frame: Week 21 up to Week 24
Population: ITT population included all participants who were randomized to study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epoetin Hospira | Mean Weekly Hemoglobin Level From Week 21 to Week 24 | 10.17 g/dL | Standard Deviation 0.847 |
| Epogen | Mean Weekly Hemoglobin Level From Week 21 to Week 24 | 10.28 g/dL | Standard Deviation 0.839 |
Comparison: Least Square (LS) mean and 95 percent confidence interval (CI) were derived from an ANCOVA model with fixed effect of treatment.95% CI: [-0.25, 0.01]
Secondary
Mean Weekly Dosage of Study Medication Through 24 Weeks
Time frame: Week 1 up to Week 24
Population: ITT population included all participants who were randomized to study treatment. Here, N signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epoetin Hospira | Mean Weekly Dosage of Study Medication Through 24 Weeks | 87.51 U/kg/week | Standard Deviation 86.405 |
| Epogen | Mean Weekly Dosage of Study Medication Through 24 Weeks | 90.95 U/kg/week | Standard Deviation 80.619 |
p-value: 0.1061Wilcoxon Rank Sum test
Secondary
Mean Weekly Hemoglobin Level Through 24 Weeks
Time frame: Week 1 up to Week 24
Population: ITT population included all participants who were randomized to study treatment. Here, N signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epoetin Hospira | Mean Weekly Hemoglobin Level Through 24 Weeks | 10.25 g/dL | Standard Deviation 0.591 |
| Epogen | Mean Weekly Hemoglobin Level Through 24 Weeks | 10.26 g/dL | Standard Deviation 0.597 |
p-value: 0.7563Wilcoxon Rank Sum test
Secondary
Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level
In this outcome measure number of participants with change (increase and decrease) in mean dose of Epoetin Hospira and Epogen were categorized and reported according to their mean hemoglobin levels. Hemoglobin levels were divided in following classes: \>11.0 g/dL, from 9.0 to 11.0 g/dL and \<9.0 g/dL
Time frame: Week 1 up to Week 24
Population: ITT population included all participants who were randomized to study treatment. Here, N signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) | Dispersion |
|---|---|---|---|---|
| Epoetin Hospira | Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level | Dose Decrease: Hb <9.0 g/dL | 49 Participants | 156128.97 |
| Epoetin Hospira | Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level | Dose Decrease: Hb (9 to 11 g/dL) | 49 Participants | — |
| Epoetin Hospira | Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level | Dose Decrease: Hb >11.0 g/dL | 147 Participants | — |
| Epoetin Hospira | Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level | Dose Increase: Hb <9.0 g/dL | 50 Participants | — |
| Epoetin Hospira | Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level | Dose Increase: Hb (9 to 11 g/dL) | 27 Participants | — |
| Epoetin Hospira | Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level | Dose Increase: Hb >11.0 g/dL | 36 Participants | — |
| Epogen | Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level | Dose Increase: Hb (9 to 11 g/dL) | 26 Participants | — |
| Epogen | Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level | Dose Decrease: Hb <9.0 g/dL | 37 Participants | 141911.73 |
| Epogen | Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level | Dose Increase: Hb <9.0 g/dL | 67 Participants | — |
| Epogen | Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level | Dose Decrease: Hb (9 to 11 g/dL) | 46 Participants | — |
| Epogen | Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level | Dose Increase: Hb >11.0 g/dL | 54 Participants | — |
| Epogen | Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level | Dose Decrease: Hb >11.0 g/dL | 150 Participants | — |
Secondary
Percentage of Participants Who Received Blood Transfusions
Time frame: Week 1 up to Week 24
Population: ITT population included all participants who were randomized to study treatment. Here, N signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Epoetin Hospira | Percentage of Participants Who Received Blood Transfusions | 6.3 percentage of participants | 156128.97 |
| Epogen | Percentage of Participants Who Received Blood Transfusions | 5.9 percentage of participants | 141911.73 |
Secondary
Percentage of Participants Who Required Permanent Dose Changes of Study Medication
Time frame: Week 1 up to Week 24
Population: Per protocol population was a subset of ITT participants who did not have major protocol violations.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Epoetin Hospira | Percentage of Participants Who Required Permanent Dose Changes of Study Medication | 86.3 percentage of participants | 156128.97 |
| Epogen | Percentage of Participants Who Required Permanent Dose Changes of Study Medication | 93.2 percentage of participants | 141911.73 |
Secondary
Percentage of Participants Who Required Temporary Dose Changes of Study Medication
Time frame: Week 1 up to Week 24
Population: Per protocol population was a subset of ITT participants who did not have major protocol violations.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Epoetin Hospira | Percentage of Participants Who Required Temporary Dose Changes of Study Medication | 7.4 percentage of participants | 156128.97 |
| Epogen | Percentage of Participants Who Required Temporary Dose Changes of Study Medication | 4.2 percentage of participants | 141911.73 |
Secondary
Percentage of Participants With Any Transient Change of Hemoglobin Greater Than (>) 2.0 Gram Per Deciliter (g/dL) in Hemoglobin Level
Time frame: Week 1 up to Week 24
Population: Safety population included all participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Epoetin Hospira | Percentage of Participants With Any Transient Change of Hemoglobin Greater Than (>) 2.0 Gram Per Deciliter (g/dL) in Hemoglobin Level | 13.1 percentage of participants | 156128.97 |
| Epogen | Percentage of Participants With Any Transient Change of Hemoglobin Greater Than (>) 2.0 Gram Per Deciliter (g/dL) in Hemoglobin Level | 14.5 percentage of participants | 141911.73 |
Secondary
Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 1 Gram Per Deciliter (g/dL)
Time frame: Week 1 up to Week 24
Population: Per protocol population was a subset of ITT participants who did not have major protocol violations.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Epoetin Hospira | Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 1 Gram Per Deciliter (g/dL) | 44.1 percentage of participants | 156128.97 |
| Epogen | Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 1 Gram Per Deciliter (g/dL) | 43.2 percentage of participants | 141911.73 |
Secondary
Percentage of Participants With Mean Weekly Hemoglobin Level Outside the Target Range
Percentage of participants who had hemoglobin level outside the target range of 9 to 11 g/dL for the specified weeks were reported.
Time frame: Week 12, 24
Population: ITT population included all participants who were randomized to study treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Epoetin Hospira | Percentage of Participants With Mean Weekly Hemoglobin Level Outside the Target Range | Week 12 | 19.0 percentage of participants |
| Epoetin Hospira | Percentage of Participants With Mean Weekly Hemoglobin Level Outside the Target Range | Week 24 | 26.8 percentage of participants |
| Epogen | Percentage of Participants With Mean Weekly Hemoglobin Level Outside the Target Range | Week 12 | 26.8 percentage of participants |
| Epogen | Percentage of Participants With Mean Weekly Hemoglobin Level Outside the Target Range | Week 24 | 28.6 percentage of participants |
Secondary
Percentage of Participants With Mean Weekly Hemoglobin Level Within the Target Range
Percentage of participants who had hemoglobin level within the target range of 9 to 11 g/dL for the specified weeks were reported.
Time frame: Week 12, 24
Population: ITT population included all participants who were randomized to study treatment.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Epoetin Hospira | Percentage of Participants With Mean Weekly Hemoglobin Level Within the Target Range | Week 12 | 81.0 percentage of participants | 156128.97 |
| Epoetin Hospira | Percentage of Participants With Mean Weekly Hemoglobin Level Within the Target Range | Week 24 | 73.2 percentage of participants | — |
| Epogen | Percentage of Participants With Mean Weekly Hemoglobin Level Within the Target Range | Week 12 | 73.2 percentage of participants | 141911.73 |
| Epogen | Percentage of Participants With Mean Weekly Hemoglobin Level Within the Target Range | Week 24 | 71.4 percentage of participants | — |
Secondary
Total Dose of Study Medication Administered
Time frame: Week 1 up to Week 24
Population: ITT population included all participants who were randomized to study treatment. Here, N signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epoetin Hospira | Total Dose of Study Medication Administered | 146752.6 units of study medication | Standard Deviation 156128.97 |
| Epogen | Total Dose of Study Medication Administered | 147145.2 units of study medication | Standard Deviation 141911.73 |
p-value: 0.3369Wilcoxon Rank Sum test
Other Pre-specified
Number of Participants That Discontinued Treatment Due to a Treatment Emergent Adverse Event
In this outcome measure number of participants who discontinued from study drug (Epoetin Hospira, Epogen) due to any AE were reported.
Time frame: Week 1 up to Week 28
Population: Safety population included all participants who received at least 1 dose of study treatment. Here, N signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) | Dispersion |
|---|---|---|---|
| Epoetin Hospira | Number of Participants That Discontinued Treatment Due to a Treatment Emergent Adverse Event | 9 Participants | 156128.97 |
| Epogen | Number of Participants That Discontinued Treatment Due to a Treatment Emergent Adverse Event | 11 Participants | 141911.73 |
Other Pre-specified
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)
ECG parameters: PR interval, QRS complex, QT interval and QTC interval. Participants with clinically significant change from baseline in ECG were as determined by the investigator.
Time frame: Baseline up to Week 28
Population: Safety population included all participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) | Dispersion |
|---|---|---|---|
| Epoetin Hospira | Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) | 0 Participants | 156128.97 |
| Epogen | Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) | 0 Participants | 141911.73 |
Other Pre-specified
Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters
Laboratory parameters: Hematology (hematocrit, hemoglobin, red blood cell count, reticulocytes, white blood cell count, neutrophils, bands, lymphocytes, monocytes, basophils, eosinophils, platelet count, mean corpuscular volume); coagulation panel (prothrombin time, international normalized ratio, activated partial thromboplastin time); clinical chemistry (blood urea nitrogen, creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, gamma-glutamyl transpeptidase, alkaline phosphatase, sodium, potassium, calcium, magnesium, phosphorus, uric acid, total protein, glucose, albumin, C-reactive protein, plasma ferritin, transferrin saturation). Participants with clinically significant change from baseline in laboratory parameters were as determined by the investigator.
Time frame: Baseline up to Week 28
Population: Safety population included all participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) | Dispersion |
|---|---|---|---|
| Epoetin Hospira | Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters | 0 Participants | 156128.97 |
| Epogen | Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters | 0 Participants | 141911.73 |
Other Pre-specified
Number of Participants With Clinically Significant Change From Baseline in Physical Examination
Physical examination included examination of the following: skin, eyes, ears, throat, cardiac, respiratory, gastrointestinal, genitourinary and musculoskeletal systems. Participants with clinically significant change from baseline in physical examination were as determined by the investigator.
Time frame: Baseline up to Week 28
Population: Safety population included all participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) | Dispersion |
|---|---|---|---|
| Epoetin Hospira | Number of Participants With Clinically Significant Change From Baseline in Physical Examination | 0 Participants | 156128.97 |
| Epogen | Number of Participants With Clinically Significant Change From Baseline in Physical Examination | 0 Participants | 141911.73 |
Other Pre-specified
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Vital sign parameters: temperature (oral, tympanic, or other), blood pressure (diastolic and systolic), heart rate (in a seated position) and dry weight (post-dialysis). Participants with clinically significant change from baseline in vital signs were as determined by the investigator.
Time frame: Baseline up to Week 28
Population: Safety population included all participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) | Dispersion |
|---|---|---|---|
| Epoetin Hospira | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | 0 Participants | 156128.97 |
| Epogen | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | 0 Participants | 141911.73 |
Other Pre-specified
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged in-patient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events from first dose of study drug to the end of study (up to Week 28) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.
Time frame: Week 1 up to Week 28
Population: Safety population included all participants who received at least 1 dose of study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) | Dispersion |
|---|---|---|---|---|
| Epoetin Hospira | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 232 Participants | 156128.97 |
| Epoetin Hospira | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 75 Participants | — |
| Epogen | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 229 Participants | 141911.73 |
| Epogen | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 82 Participants | — |
Other Pre-specified
Number of Participants With Treatment-Emergent Adverse Events by Severity
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug to the end of study (up to Week 28) that were absent before treatment or that worsened relative to pre-treatment state. An AE was assessed according to severity; mild (AE was transient and easily tolerated by the participant), moderate (caused problem that did not interfere significantly with usual activities) and severe (caused problem that interferes significantly with usual activities and might be incapacitating or life-threatening).
Time frame: Week 1 up to Week 28
Population: Safety population included all participants who received at least 1 dose of study treatment. Here, N signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) | Dispersion |
|---|---|---|---|---|
| Epoetin Hospira | Number of Participants With Treatment-Emergent Adverse Events by Severity | Mild | 116 Participants | 156128.97 |
| Epoetin Hospira | Number of Participants With Treatment-Emergent Adverse Events by Severity | Moderate | 74 Participants | — |
| Epoetin Hospira | Number of Participants With Treatment-Emergent Adverse Events by Severity | Severe | 42 Participants | — |
| Epogen | Number of Participants With Treatment-Emergent Adverse Events by Severity | Mild | 111 Participants | 141911.73 |
| Epogen | Number of Participants With Treatment-Emergent Adverse Events by Severity | Moderate | 69 Participants | — |
| Epogen | Number of Participants With Treatment-Emergent Adverse Events by Severity | Severe | 49 Participants | — |
Other Pre-specified
Number of Participants With Treatment Related Adverse Events (AEs)
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.
Time frame: Week 1 up to Week 28
Population: Safety population included all participants who received at least 1 dose of study treatment. Here, N signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) | Dispersion |
|---|---|---|---|
| Epoetin Hospira | Number of Participants With Treatment Related Adverse Events (AEs) | 7 Participants | 156128.97 |
| Epogen | Number of Participants With Treatment Related Adverse Events (AEs) | 7 Participants | 141911.73 |
Other Pre-specified
Percentage of Participants With Anti-Recombinant Human Erythropoietin (Anti-rhEPO) Antibodies
Percentage of participants with presence of anti-rhEPO antibodies were reported in this outcome measure. Radioimmunoprecipitation assay method was used to determine the presence of anti-rhEPO antibodies.
Time frame: Week 1 up to Week 28
Population: Safety population included all participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Epoetin Hospira | Percentage of Participants With Anti-Recombinant Human Erythropoietin (Anti-rhEPO) Antibodies | 0.4 percentage of participants | 156128.97 |
| Epogen | Percentage of Participants With Anti-Recombinant Human Erythropoietin (Anti-rhEPO) Antibodies | 0.0 percentage of participants | 141911.73 |
Other Pre-specified
Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL)
Time frame: Week 1 up to Week 24
Population: Safety population included all participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Epoetin Hospira | Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL) | 21.6 percentage of participants | 156128.97 |
| Epogen | Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL) | 23.0 percentage of participants | 141911.73 |
Other Pre-specified
Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL)
Time frame: Week 1 up to Week 24
Population: Safety population included all participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Epoetin Hospira | Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL) | 5.3 percentage of participants | 156128.97 |
| Epogen | Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL) | 10.9 percentage of participants | 141911.73 |