Chronic Kidney Disease, Chronic Renal Failure
Conditions
Brief summary
The purpose of this study is to demonstrate therapeutic equivalence of subcutaneous (SC) Epoetin Hospira compared to SC Epogen (Amgen), based on maintenance of hemoglobin (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) dose administered IV or SC, 1 to 3 times per week for whom the following apply: * A change in Epogen dosing of no more than 10% from the mean * Mean hemoglobin between 9.0 and 11.0 g/dL * No more than one hemoglobin result outside of range from 9.0-11.0 g/dL * No hemoglobin result more than ±1 g/dL from the mean hemoglobin level 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 plasma 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 postmenopausal for at least one year prior to randomization, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least one 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 12 weeks 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 that in the Investigator's opinion may be significant to exclude participation in the study, including but not limited to demyelinating diseases such as multiple sclerosis, 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 into the Maintenance Period 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 30 to Week 34: Maintenance Period | Week 30 up to Week 34 |
| Mean Weekly Dosage of Study Medication From Week 30 to Week 34: Maintenance Period | Week 30 up to Week 34 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Weekly Hemoglobin Level From Week 19 to Week 34: Maintenance Period | Week 19 up to Week 34 | — |
| Mean Weekly Dosage of Study Medication From Week 19 to Week 34: Maintenance Period | Week 19 up to Week 34 | — |
| Total Dose of Study Medication Administered: Maintenance Period | Week 19 up to Week 34 | In this outcome measure mean of total dose of study medication administered in maintenance period was reported. |
| Percentage of Participants With Mean Weekly Hemoglobin Level Within the Target Range: Maintenance Period | Week 26, 34 | 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: Maintenance Period | Week 19 up to Week 34 | — |
| Percentage of Participants Who Required Temporary Dose Changes: Maintenance Period | Week 19 up to Week 34 | — |
| Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 1.0 Gram Per Deciliter (g/dL): Maintenance Period | Week 19 up to Week 34 | — |
| Percentage of Participants With Mean Weekly Hemoglobin Level Outside the Target Range: Maintenance Period | Week 26, 34 | 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 Qualified as Optimally Titrated and Stable: Titration Period | Week 1 up to Week 18 | — |
| Percentage of Participants Who Received Blood Transfusions: Maintenance Period | Week 19 up to Week 34 | — |
| Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level: Maintenance Period | Week 19 up to Week 34 | 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 Level Greater Than (>) 2.0 Gram Per Deciliter (g/dL) in Hemoglobin Level: Maintenance Period | Week 19 up to Week 34 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL): Maintenance Period | Week 19 up to Week 34 | — |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events. |
| Number of Participants With Treatment-Emergent Adverse Events by Severity | Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An AE was assessed according to severity; mild (AE was transient and easily tolerated by the participant), moderate (caused problem that did not interfere significantly with usual activities) and severe (caused problem that interferes significantly with usual activities and might be incapacitating or life-threatening). |
| Number of Participants With Treatment Related Adverse Events (AEs) | Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38 | An AE was any untoward medical occurrence in a participant who received study drug. |
| Number of Participants That Discontinued Treatment Due to a Treatment Emergent Adverse Event | Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38 | In this outcome measure number of participants 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 | Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38 | 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 | Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38 | 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) | Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38 | 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 | Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38 | 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 | Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38 | 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. |
| Percentage of Participants With General Tolerability | Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38 | General tolerability was classified as: 1) excellent tolerability = no reaction, 2) good tolerability = minimal reaction, 3) mild intolerability = reaction above that normally observed with any kind of subcutaneous product, 4) moderate intolerability = marked reaction, but no need for discontinuation of treatment and 5) severe intolerability = treatment discontinued due to intolerability. |
| Percentage of Participants With Local Tolerability | Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38 | Local tolerability was classified as: 1) excellent tolerability = no reaction at site of injection, 2) good tolerability = minimal reaction at site of injection normally observed with any kind of subcutaneous product, 3) mild intolerability = reaction at site of injection above that normally observed with any kind of subcutaneous product, 4) moderate intolerability = marked reaction, but no need for discontinuation of treatment and 5) severe intolerability = treatment discontinued due to intolerability. |
| Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL): Maintenance Period | Week 19 up to Week 34 | — |
Countries
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 During titration period participants who were on Epogen intravenous (IV) regimen prior to this study, were titrated and optimally stabilized to receive subcutaneous (SC) injection of Epoetin Hospira. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose of study treatment was adjusted to maintain hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18). During maintenance period participants received SC injection of Epoetin Hospira at optimal dose demonstrated in titration period 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38). | 160 |
| Epogen During titration period participants who were on Epogen IV regimen prior to enrollment in this study, were titrated and optimally stabilized to receive SC injection of Epogen. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18). During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38). | 160 |
| Total | 320 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Maintenance Period (16 Weeks) | Adverse Event | 3 | 2 |
| Maintenance Period (16 Weeks) | Did not meet criteria | 0 | 2 |
| Maintenance Period (16 Weeks) | Elevated Hemoglobin | 1 | 0 |
| Maintenance Period (16 Weeks) | Kidney transplant | 3 | 1 |
| Maintenance Period (16 Weeks) | Long term hospitalization | 0 | 1 |
| Maintenance Period (16 Weeks) | Lost to Follow-up | 1 | 2 |
| Maintenance Period (16 Weeks) | Physician Decision | 1 | 2 |
| Maintenance Period (16 Weeks) | Site closure | 3 | 1 |
| Maintenance Period (16 Weeks) | Sponsor's Decision | 1 | 0 |
| Maintenance Period (16 Weeks) | Started Peritoneal Dialysis | 1 | 0 |
| Maintenance Period (16 Weeks) | Withdrawal by Subject | 4 | 6 |
| Titration Period (18 Weeks) | Adverse Event | 4 | 6 |
| Titration Period (18 Weeks) | Did not meet criteria | 32 | 32 |
Baseline characteristics
| Characteristic | Epoetin Hospira | Epogen | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 51 Participants | 43 Participants | 94 Participants |
| Age, Categorical Between 18 and 65 years | 109 Participants | 117 Participants | 226 Participants |
| Sex: Female, Male Female | 77 Participants | 84 Participants | 161 Participants |
| Sex: Female, Male Male | 83 Participants | 76 Participants | 159 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 16 / 80 | 10 / 86 | 27 / 122 | 24 / 122 |
| serious Total, serious adverse events | 12 / 80 | 22 / 86 | 23 / 122 | 33 / 122 |
Outcome results
Primary
Mean Weekly Dosage of Study Medication From Week 30 to Week 34: Maintenance Period
Time frame: Week 30 up to Week 34
Population: This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epoetin Hospira: Maintenance Period | Mean Weekly Dosage of Study Medication From Week 30 to Week 34: Maintenance Period | 82.07 unit per kilogram per week (U/kg/week) | Standard Deviation 95.517 |
| Epogen: Maintenance Period | Mean Weekly Dosage of Study Medication From Week 30 to Week 34: Maintenance Period | 79.14 unit per kilogram per week (U/kg/week) | Standard Deviation 82.264 |
Comparison: LS mean and 95 percent CI derived from an ANCOVA model with fixed effect of treatment.95% CI: [-14.51, 9.82]
Primary
Mean Weekly Hemoglobin Level From Week 30 to Week 34: Maintenance Period
Time frame: Week 30 up to Week 34
Population: This outcome measure was planned not to be analyzed in titration period. Intent-to-treat (ITT) population included all participants who were randomized into the maintenance period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epoetin Hospira: Maintenance Period | Mean Weekly Hemoglobin Level From Week 30 to Week 34: Maintenance Period | 10.17 g/dL | Standard Deviation 0.821 |
| Epogen: Maintenance Period | Mean Weekly Hemoglobin Level From Week 30 to Week 34: Maintenance Period | 10.11 g/dL | Standard Deviation 0.838 |
Comparison: Least square (LS) mean and 95 percent confidence interval (CI) derived from an analysis of covariance (ANCOVA) model with fixed effect of treatment.95% CI: [-0.17, 0.24]
Secondary
Mean Weekly Dosage of Study Medication From Week 19 to Week 34: Maintenance Period
Time frame: Week 19 up to Week 34
Population: This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period. Here, N signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epoetin Hospira: Maintenance Period | Mean Weekly Dosage of Study Medication From Week 19 to Week 34: Maintenance Period | 81.93 U/kg/week | Standard Deviation 93.824 |
| Epogen: Maintenance Period | Mean Weekly Dosage of Study Medication From Week 19 to Week 34: Maintenance Period | 75.08 U/kg/week | Standard Deviation 72.174 |
p-value: 0.6895Wilcoxon Rank Sum test
Secondary
Mean Weekly Hemoglobin Level From Week 19 to Week 34: Maintenance Period
Time frame: Week 19 up to Week 34
Population: This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period. Here, Number of Participants Analyzed (N) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epoetin Hospira: Maintenance Period | Mean Weekly Hemoglobin Level From Week 19 to Week 34: Maintenance Period | 10.20 g/dL | Standard Deviation 0.625 |
| Epogen: Maintenance Period | Mean Weekly Hemoglobin Level From Week 19 to Week 34: Maintenance Period | 10.22 g/dL | Standard Deviation 0.665 |
p-value: 0.8338Two-sample t-test
Secondary
Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level: Maintenance Period
In this outcome measure number of participants with change (increase and decrease) in mean dose of Epoetin Hospira and Epogen were categorized and reported according to their mean hemoglobin levels. Hemoglobin levels were divided in following classes: \>11.0 g/dL, from 9.0 to 11.0 g/dL and \<9.0 g/dL
Time frame: Week 19 up to Week 34
Population: This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period. Here, N signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Epoetin Hospira: Maintenance Period | Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level: Maintenance Period | Dose Decrease: Hb >11.0 g/dL | 35 Participants |
| Epoetin Hospira: Maintenance Period | Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level: Maintenance Period | Dose Decrease: Hb <9.0 g/dL | 9 Participants |
| Epoetin Hospira: Maintenance Period | Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level: Maintenance Period | Dose Decrease: Hb (9.0 to 11.0 g/dL) | 20 Participants |
| Epoetin Hospira: Maintenance Period | Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level: Maintenance Period | Dose Increase: Hb <9.0 g/dL | 24 Participants |
| Epoetin Hospira: Maintenance Period | Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level: Maintenance Period | Dose Increase: Hb (9.0 to 11.0 g/dL) | 11 Participants |
| Epoetin Hospira: Maintenance Period | Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level: Maintenance Period | Dose Increase: Hb >11.0 g/dL | 7 Participants |
| Epogen: Maintenance Period | Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level: Maintenance Period | Dose Increase: Hb (9.0 to 11.0 g/dL) | 3 Participants |
| Epogen: Maintenance Period | Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level: Maintenance Period | Dose Decrease: Hb >11.0 g/dL | 40 Participants |
| Epogen: Maintenance Period | Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level: Maintenance Period | Dose Increase: Hb <9.0 g/dL | 23 Participants |
| Epogen: Maintenance Period | Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level: Maintenance Period | Dose Decrease: Hb <9.0 g/dL | 10 Participants |
| Epogen: Maintenance Period | Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level: Maintenance Period | Dose Increase: Hb >11.0 g/dL | 13 Participants |
| Epogen: Maintenance Period | Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level: Maintenance Period | Dose Decrease: Hb (9.0 to 11.0 g/dL) | 14 Participants |
Secondary
Percentage of Participants Who Qualified as Optimally Titrated and Stable: Titration Period
Time frame: Week 1 up to Week 18
Population: This outcome measure was planned not to be analyzed in maintenance period. Safety analysis population for titration period included all participants who received at least 1 dose of study treatment in titration period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epoetin Hospira: Maintenance Period | Percentage of Participants Who Qualified as Optimally Titrated and Stable: Titration Period | 47.5 percentage of participants |
| Epogen: Maintenance Period | Percentage of Participants Who Qualified as Optimally Titrated and Stable: Titration Period | 47.7 percentage of participants |
Secondary
Percentage of Participants Who Received Blood Transfusions: Maintenance Period
Time frame: Week 19 up to Week 34
Population: This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epoetin Hospira: Maintenance Period | Percentage of Participants Who Received Blood Transfusions: Maintenance Period | 4.0 percentage of participants |
| Epogen: Maintenance Period | Percentage of Participants Who Received Blood Transfusions: Maintenance Period | 4.1 percentage of participants |
Secondary
Percentage of Participants Who Required Permanent Dose Changes: Maintenance Period
Time frame: Week 19 up to Week 34
Population: This outcome measure was planned not to be analyzed in titration period. Per protocol population included all participants who were randomized into the maintenance period and who did not have major protocol violations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epoetin Hospira: Maintenance Period | Percentage of Participants Who Required Permanent Dose Changes: Maintenance Period | 30.2 percentage of participants |
| Epogen: Maintenance Period | Percentage of Participants Who Required Permanent Dose Changes: Maintenance Period | 25.0 percentage of participants |
Secondary
Percentage of Participants Who Required Temporary Dose Changes: Maintenance Period
Time frame: Week 19 up to Week 34
Population: This outcome measure was planned not to be analyzed in titration period. Per protocol population included all participants who were randomized into the maintenance period and who did not have major protocol violations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epoetin Hospira: Maintenance Period | Percentage of Participants Who Required Temporary Dose Changes: Maintenance Period | 55.8 percentage of participants |
| Epogen: Maintenance Period | Percentage of Participants Who Required Temporary Dose Changes: Maintenance Period | 62.0 percentage of participants |
Secondary
Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 1.0 Gram Per Deciliter (g/dL): Maintenance Period
Time frame: Week 19 up to Week 34
Population: This outcome measure was planned not to be analyzed in titration period. Per protocol population included all participants who were randomized into the maintenance period and who did not have major protocol violations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epoetin Hospira: Maintenance Period | Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 1.0 Gram Per Deciliter (g/dL): Maintenance Period | 29.1 percentage of participants |
| Epogen: Maintenance Period | Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 1.0 Gram Per Deciliter (g/dL): Maintenance Period | 52.2 percentage of participants |
Secondary
Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 2.0 Gram Per Deciliter (g/dL) in Hemoglobin Level: Maintenance Period
Time frame: Week 19 up to Week 34
Population: This outcome measure was planned not to be analyzed in titration period. Safety analysis population for maintenance period included all participants who received at least 1 dose of study treatment in maintenance period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epoetin Hospira: Maintenance Period | Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 2.0 Gram Per Deciliter (g/dL) in Hemoglobin Level: Maintenance Period | 6.6 percentage of participants |
| Epogen: Maintenance Period | Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 2.0 Gram Per Deciliter (g/dL) in Hemoglobin Level: Maintenance Period | 10.7 percentage of participants |
Secondary
Percentage of Participants With Mean Weekly Hemoglobin Level Outside the Target Range: Maintenance Period
Percentage of participants who had hemoglobin level outside the target range of 9 to 11 g/dL for the specified weeks were reported.
Time frame: Week 26, 34
Population: This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Epoetin Hospira: Maintenance Period | Percentage of Participants With Mean Weekly Hemoglobin Level Outside the Target Range: Maintenance Period | Week 34 | 10.1 percentage of participants |
| Epoetin Hospira: Maintenance Period | Percentage of Participants With Mean Weekly Hemoglobin Level Outside the Target Range: Maintenance Period | Week 26 | 13.5 percentage of participants |
| Epogen: Maintenance Period | Percentage of Participants With Mean Weekly Hemoglobin Level Outside the Target Range: Maintenance Period | Week 26 | 19.3 percentage of participants |
| Epogen: Maintenance Period | Percentage of Participants With Mean Weekly Hemoglobin Level Outside the Target Range: Maintenance Period | Week 34 | 13.0 percentage of participants |
Secondary
Percentage of Participants With Mean Weekly Hemoglobin Level Within the Target Range: Maintenance Period
Percentage of participants who had hemoglobin level within the target range of 9 to 11 g/dL for the specified weeks were reported.
Time frame: Week 26, 34
Population: This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Epoetin Hospira: Maintenance Period | Percentage of Participants With Mean Weekly Hemoglobin Level Within the Target Range: Maintenance Period | Week 26 | 73.5 percentage of participants |
| Epoetin Hospira: Maintenance Period | Percentage of Participants With Mean Weekly Hemoglobin Level Within the Target Range: Maintenance Period | Week 34 | 79.8 percentage of participants |
| Epogen: Maintenance Period | Percentage of Participants With Mean Weekly Hemoglobin Level Within the Target Range: Maintenance Period | Week 26 | 60.9 percentage of participants |
| Epogen: Maintenance Period | Percentage of Participants With Mean Weekly Hemoglobin Level Within the Target Range: Maintenance Period | Week 34 | 74.0 percentage of participants |
Secondary
Total Dose of Study Medication Administered: Maintenance Period
In this outcome measure mean of total dose of study medication administered in maintenance period was reported.
Time frame: Week 19 up to Week 34
Population: This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period. Here, N signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epoetin Hospira: Maintenance Period | Total Dose of Study Medication Administered: Maintenance Period | 102003.2 units of study medication | Standard Deviation 135560.52 |
| Epogen: Maintenance Period | Total Dose of Study Medication Administered: Maintenance Period | 86478.5 units of study medication | Standard Deviation 83351.03 |
p-value: 0.9177Wilcoxon 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 discontinued from study drug (Epoetin Hospira, Epogen) due to any AE were reported.
Time frame: Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38
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) |
|---|---|---|
| Epoetin Hospira: Maintenance Period | Number of Participants That Discontinued Treatment Due to a Treatment Emergent Adverse Event | 4 Participants |
| Epogen: Maintenance Period | Number of Participants That Discontinued Treatment Due to a Treatment Emergent Adverse Event | 6 Participants |
| Epoetin Hospira: Maintenance Period | Number of Participants That Discontinued Treatment Due to a Treatment Emergent Adverse Event | 4 Participants |
| Epogen: Maintenance Period | Number of Participants That Discontinued Treatment Due to a Treatment Emergent Adverse Event | 4 Participants |
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: Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38
Population: Safety population included all participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epoetin Hospira: Maintenance Period | Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) | 0 Participants |
| Epogen: Maintenance Period | Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) | 0 Participants |
| Epoetin Hospira: Maintenance Period | Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) | 0 Participants |
| Epogen: Maintenance Period | Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) | 0 Participants |
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: Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38
Population: Safety population included all participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epoetin Hospira: Maintenance Period | Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters | 0 Participants |
| Epogen: Maintenance Period | Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters | 0 Participants |
| Epoetin Hospira: Maintenance Period | Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters | 0 Participants |
| Epogen: Maintenance Period | Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters | 0 Participants |
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: Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38
Population: Safety population included all participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epoetin Hospira: Maintenance Period | Number of Participants With Clinically Significant Change From Baseline in Physical Examination | 0 Participants |
| Epogen: Maintenance Period | Number of Participants With Clinically Significant Change From Baseline in Physical Examination | 0 Participants |
| Epoetin Hospira: Maintenance Period | Number of Participants With Clinically Significant Change From Baseline in Physical Examination | 0 Participants |
| Epogen: Maintenance Period | Number of Participants With Clinically Significant Change From Baseline in Physical Examination | 0 Participants |
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: Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38
Population: Safety population included all participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epoetin Hospira: Maintenance Period | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | 0 Participants |
| Epogen: Maintenance Period | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | 0 Participants |
| Epoetin Hospira: Maintenance Period | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | 0 Participants |
| Epogen: Maintenance Period | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | 0 Participants |
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. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.
Time frame: Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38
Population: Safety population included all participants who received at least 1 dose of study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Epoetin Hospira: Maintenance Period | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 45 Participants |
| Epoetin Hospira: Maintenance Period | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 12 Participants |
| Epogen: Maintenance Period | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 22 Participants |
| Epogen: Maintenance Period | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 54 Participants |
| Epoetin Hospira: Maintenance Period | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 85 Participants |
| Epoetin Hospira: Maintenance Period | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 23 Participants |
| Epogen: Maintenance Period | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 86 Participants |
| Epogen: Maintenance Period | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 33 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. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An AE was assessed according to severity; mild (AE was transient and easily tolerated by the participant), moderate (caused problem that did not interfere significantly with usual activities) and severe (caused problem that interferes significantly with usual activities and might be incapacitating or life-threatening).
Time frame: Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38
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) |
|---|---|---|---|
| Epoetin Hospira: Maintenance Period | Number of Participants With Treatment-Emergent Adverse Events by Severity | Mild | 21 Participants |
| Epoetin Hospira: Maintenance Period | Number of Participants With Treatment-Emergent Adverse Events by Severity | Severe | 9 Participants |
| Epoetin Hospira: Maintenance Period | Number of Participants With Treatment-Emergent Adverse Events by Severity | Moderate | 15 Participants |
| Epogen: Maintenance Period | Number of Participants With Treatment-Emergent Adverse Events by Severity | Mild | 23 Participants |
| Epogen: Maintenance Period | Number of Participants With Treatment-Emergent Adverse Events by Severity | Severe | 15 Participants |
| Epogen: Maintenance Period | Number of Participants With Treatment-Emergent Adverse Events by Severity | Moderate | 16 Participants |
| Epoetin Hospira: Maintenance Period | Number of Participants With Treatment-Emergent Adverse Events by Severity | Moderate | 24 Participants |
| Epoetin Hospira: Maintenance Period | Number of Participants With Treatment-Emergent Adverse Events by Severity | Mild | 42 Participants |
| Epoetin Hospira: Maintenance Period | Number of Participants With Treatment-Emergent Adverse Events by Severity | Severe | 19 Participants |
| Epogen: Maintenance Period | Number of Participants With Treatment-Emergent Adverse Events by Severity | Mild | 41 Participants |
| Epogen: Maintenance Period | Number of Participants With Treatment-Emergent Adverse Events by Severity | Severe | 18 Participants |
| Epogen: Maintenance Period | Number of Participants With Treatment-Emergent Adverse Events by Severity | Moderate | 27 Participants |
Other Pre-specified
Number of Participants With Treatment Related Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received study drug.
Time frame: Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38
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) |
|---|---|---|
| Epoetin Hospira: Maintenance Period | Number of Participants With Treatment Related Adverse Events (AEs) | 1 Participants |
| Epogen: Maintenance Period | Number of Participants With Treatment Related Adverse Events (AEs) | 4 Participants |
| Epoetin Hospira: Maintenance Period | Number of Participants With Treatment Related Adverse Events (AEs) | 7 Participants |
| Epogen: Maintenance Period | Number of Participants With Treatment Related Adverse Events (AEs) | 11 Participants |
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: Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38
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 (NUMBER) |
|---|---|---|
| Epoetin Hospira: Maintenance Period | Percentage of Participants With Anti-Recombinant Human Erythropoietin (Anti-rhEPO) Antibodies | 0.0 percentage of participants |
| Epogen: Maintenance Period | Percentage of Participants With Anti-Recombinant Human Erythropoietin (Anti-rhEPO) Antibodies | 0.0 percentage of participants |
| Epoetin Hospira: Maintenance Period | Percentage of Participants With Anti-Recombinant Human Erythropoietin (Anti-rhEPO) Antibodies | 0.0 percentage of participants |
| Epogen: Maintenance Period | Percentage of Participants With Anti-Recombinant Human Erythropoietin (Anti-rhEPO) Antibodies | 0.0 percentage of participants |
Other Pre-specified
Percentage of Participants With General Tolerability
General tolerability was classified as: 1) excellent tolerability = no reaction, 2) good tolerability = minimal reaction, 3) mild intolerability = reaction above that normally observed with any kind of subcutaneous product, 4) moderate intolerability = marked reaction, but no need for discontinuation of treatment and 5) severe intolerability = treatment discontinued due to intolerability.
Time frame: Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38
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 (NUMBER) |
|---|---|---|---|
| Epoetin Hospira: Maintenance Period | Percentage of Participants With General Tolerability | Moderate Intolerability | 0.0 percentage of participants |
| Epoetin Hospira: Maintenance Period | Percentage of Participants With General Tolerability | Good Tolerability | 28.8 percentage of participants |
| Epoetin Hospira: Maintenance Period | Percentage of Participants With General Tolerability | Severe Intolerability | 0.0 percentage of participants |
| Epoetin Hospira: Maintenance Period | Percentage of Participants With General Tolerability | Mild Intolerability | 2.5 percentage of participants |
| Epoetin Hospira: Maintenance Period | Percentage of Participants With General Tolerability | Excellent Tolerability | 68.8 percentage of participants |
| Epogen: Maintenance Period | Percentage of Participants With General Tolerability | Mild Intolerability | 2.3 percentage of participants |
| Epogen: Maintenance Period | Percentage of Participants With General Tolerability | Moderate Intolerability | 2.3 percentage of participants |
| Epogen: Maintenance Period | Percentage of Participants With General Tolerability | Severe Intolerability | 0.0 percentage of participants |
| Epogen: Maintenance Period | Percentage of Participants With General Tolerability | Good Tolerability | 25.6 percentage of participants |
| Epogen: Maintenance Period | Percentage of Participants With General Tolerability | Excellent Tolerability | 67.4 percentage of participants |
| Epoetin Hospira: Maintenance Period | Percentage of Participants With General Tolerability | Mild Intolerability | 4.9 percentage of participants |
| Epoetin Hospira: Maintenance Period | Percentage of Participants With General Tolerability | Excellent Tolerability | 63.9 percentage of participants |
| Epoetin Hospira: Maintenance Period | Percentage of Participants With General Tolerability | Good Tolerability | 27.0 percentage of participants |
| Epoetin Hospira: Maintenance Period | Percentage of Participants With General Tolerability | Moderate Intolerability | 0.0 percentage of participants |
| Epoetin Hospira: Maintenance Period | Percentage of Participants With General Tolerability | Severe Intolerability | 1.6 percentage of participants |
| Epogen: Maintenance Period | Percentage of Participants With General Tolerability | Moderate Intolerability | 2.5 percentage of participants |
| Epogen: Maintenance Period | Percentage of Participants With General Tolerability | Good Tolerability | 27.9 percentage of participants |
| Epogen: Maintenance Period | Percentage of Participants With General Tolerability | Excellent Tolerability | 50.8 percentage of participants |
| Epogen: Maintenance Period | Percentage of Participants With General Tolerability | Mild Intolerability | 16.4 percentage of participants |
| Epogen: Maintenance Period | Percentage of Participants With General Tolerability | Severe Intolerability | 1.6 percentage of participants |
Other Pre-specified
Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL): Maintenance Period
Time frame: Week 19 up to Week 34
Population: This outcome measure was planned not to be analyzed in titration period. Safety analysis population for maintenance period included all participants who received at least 1 dose of study treatment in maintenance period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epoetin Hospira: Maintenance Period | Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL): Maintenance Period | 9.8 percentage of participants |
| Epogen: Maintenance Period | Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL): Maintenance Period | 19.7 percentage of participants |
Other Pre-specified
Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL): Maintenance Period
Time frame: Week 19 up to Week 34
Population: This outcome measure was planned not to be analyzed in titration period. Safety analysis population for maintenance period included all participants who received at least 1 dose of study treatment in maintenance period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epoetin Hospira: Maintenance Period | Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL): Maintenance Period | 4.1 percentage of participants |
| Epogen: Maintenance Period | Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL): Maintenance Period | 9.0 percentage of participants |
Other Pre-specified
Percentage of Participants With Local Tolerability
Local tolerability was classified as: 1) excellent tolerability = no reaction at site of injection, 2) good tolerability = minimal reaction at site of injection normally observed with any kind of subcutaneous product, 3) mild intolerability = reaction at site of injection above that normally observed with any kind of subcutaneous product, 4) moderate intolerability = marked reaction, but no need for discontinuation of treatment and 5) severe intolerability = treatment discontinued due to intolerability.
Time frame: Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38
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 (NUMBER) |
|---|---|---|---|
| Epoetin Hospira: Maintenance Period | Percentage of Participants With Local Tolerability | Excellent Tolerability | 70.0 percentage of participants |
| Epoetin Hospira: Maintenance Period | Percentage of Participants With Local Tolerability | Moderate Intolerability | 1.3 percentage of participants |
| Epoetin Hospira: Maintenance Period | Percentage of Participants With Local Tolerability | Good Tolerability | 25.0 percentage of participants |
| Epoetin Hospira: Maintenance Period | Percentage of Participants With Local Tolerability | Severe Intolerability | 0.0 percentage of participants |
| Epoetin Hospira: Maintenance Period | Percentage of Participants With Local Tolerability | Mild Intolerability | 3.8 percentage of participants |
| Epogen: Maintenance Period | Percentage of Participants With Local Tolerability | Good Tolerability | 25.6 percentage of participants |
| Epogen: Maintenance Period | Percentage of Participants With Local Tolerability | Excellent Tolerability | 66.3 percentage of participants |
| Epogen: Maintenance Period | Percentage of Participants With Local Tolerability | Mild Intolerability | 5.8 percentage of participants |
| Epogen: Maintenance Period | Percentage of Participants With Local Tolerability | Moderate Intolerability | 1.2 percentage of participants |
| Epogen: Maintenance Period | Percentage of Participants With Local Tolerability | Severe Intolerability | 0.0 percentage of participants |
| Epoetin Hospira: Maintenance Period | Percentage of Participants With Local Tolerability | Moderate Intolerability | 1.6 percentage of participants |
| Epoetin Hospira: Maintenance Period | Percentage of Participants With Local Tolerability | Excellent Tolerability | 67.2 percentage of participants |
| Epoetin Hospira: Maintenance Period | Percentage of Participants With Local Tolerability | Good Tolerability | 24.6 percentage of participants |
| Epoetin Hospira: Maintenance Period | Percentage of Participants With Local Tolerability | Severe Intolerability | 0.0 percentage of participants |
| Epoetin Hospira: Maintenance Period | Percentage of Participants With Local Tolerability | Mild Intolerability | 4.1 percentage of participants |
| Epogen: Maintenance Period | Percentage of Participants With Local Tolerability | Moderate Intolerability | 3.3 percentage of participants |
| Epogen: Maintenance Period | Percentage of Participants With Local Tolerability | Good Tolerability | 30.3 percentage of participants |
| Epogen: Maintenance Period | Percentage of Participants With Local Tolerability | Excellent Tolerability | 54.1 percentage of participants |
| Epogen: Maintenance Period | Percentage of Participants With Local Tolerability | Severe Intolerability | 2.5 percentage of participants |
| Epogen: Maintenance Period | Percentage of Participants With Local Tolerability | Mild Intolerability | 9.0 percentage of participants |