Chronic Renal Failure Requiring Hemodialysis
Conditions
Keywords
Chronic renal failure, hemodialysis
Brief summary
The purpose of the study is to determine the long-term safety in treatment-emergent adverse events (TEAEs) of intravenous (IV) administration of Epoetin Hospira for maintenance of target hemoglobin (Hgb) levels in patients treated for anemia associated with chronic renal failure and on hemodialysis.
Interventions
BIOLOGICALEpoetin Hospira
Intravenous (IV) injection
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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 the risks and benefits of the study have been explained prior to any study-related activities. 2. Patient previously completed the core study Treatment Period up to and including Week 24 study assessments per protocol and is willing to continue open-label Epoetin Hospira for up to 48 weeks. 3. If female, patient must be postmenopausal for at least 1 year prior to enrollment, 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 enrollment * Intrauterine device * 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 enrollment. 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 open-label dose. 4. Adequate methods of contraception to prevent pregnancy are to be maintained throughout the course of the study in both male and female study subjects.
Exclusion criteria
1. Patient had a serious or severe adverse event in the core study that, in the opinion of the Investigator, was probably or definitely related to epoetin use and precluded safe use of epoetin. 2. Any of the following that developed during the core study and prior to enrollment: * 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) 3. A patient with any active, uncontrolled systemic, inflammatory, or malignant disease that developed during the core study and 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. 4. Any newly developed 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 study participation. 5. A female patient who is pregnant, lactating, or planning a pregnancy during the study. 6. History of drug abuse or alcohol abuse during the core study prior to enrollment as determined by the Investigator. 7. Current participation or participation in a drug or other investigational research study within 30 days prior to enrollment (except the core study or any observational studies with prior written approval from Hospira). 8. 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. 9. Evidence of human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg). 10. A patient who, in the Investigator's opinion, has any clinically significant abnormal laboratory results that may impact patient safety.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Treatment Emergent Adverse Events (AEs): Week 1 | Up through 7 days after first dose of study drug (Week 1) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state. |
| Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 48 | Week 1 up to Week 48 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state. |
| Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 37 to 48 | Week 37 up to Week 48 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state. |
| Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 25 to 36 | Week 25 up to Week 36 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state. |
| Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 13 to 24 | Week 13 up to Week 24 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state. |
| Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 12 | Week 1 up to Week 12 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Hemoglobin Levels for Interval of 12 Weeks | Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48 | — |
| Mean Weekly Dosage of Epoetin Hospira : Over Week 1 to 48 | Week 1 up to Week 48 | — |
| Mean Weekly Dosage of Epoetin Hospira for Interval of 12 Weeks | Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48 | — |
| Mean Hemoglobin Levels: Over Week 1 to 48 | Week 1 up to Week 48 | — |
| Mean Hematocrit Levels: Over Week 1 to 48 | Week 1 up to Week 48 | Hematocrit is defined as the percentage of red blood cells in the blood. |
| Mean Hematocrit Levels for Interval of 12 Weeks | Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48 | Hematocrit is defined as the percentage of red blood cells in the blood. |
| Percentage of Participants With Hemoglobin Level Outside the Target Range | Week 1 up to Week 48 | Percentage of participants with hemoglobin level outside the target range of 9.0 to 11.0 g/dL were reported. |
| Percentage of Participants Who Received Blood Transfusions | Week 1 up to Week 48 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinically Significant Change From Baseline in Hemoglobin Levels | Baseline up to Week 48 | Participants with clinically significant change from baseline in hemoglobin levels were upon investigator's discretion. |
| Percentage of Participants With Anti-Recombinant Human Erythropoietin (Anti-rhEPO) Antibodies | Baseline, Week 48 | Percentage of participants with at least 1 positive anti-rhEPO antibody were reported. Radioimmunoprecipitation assay was used to determine the presence of anti-rhEPO antibodies. |
| Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL) | Week 1 up to Week 48 | — |
| Number of Participants With Clinically Significant Change From Baseline in Physical Examinations | Baseline up to Week 48 | Physical examination included examination of the skin, eyes, ears, nose, throat, head, neck, thyroid, lungs, chest, abdomen, extremities, lymphatic, cardiovascular, musculoskeletal and neurological systems. Participants for any clinically significant changes in physical examination were based on the investigator's discretion. |
| Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiogram (ECG) | Baseline up to Week 48 | ECG parameters included: PR interval, QRS complex, QT interval and QTC interval. Participants with clinically significant change from baseline in 12-lead ECGs were based on investigator's discretion. |
| Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL) | Week 1 up to Week 48 | — |
| Number of Participants With Clinically Significant Change From Baseline in Laboratory Tests | Baseline up to Week 48 | Laboratory tests included: Hematology (hematocrit, hemoglobin, red blood cells count, reticulocytes, white blood cells count, neutrophils, bands, lymphocytes, monocytes, basophils, eosinophils, platelets, mean corpuscular volume); Coagulation panel (prothrombin time, international normalized ratio, activated partial thromboplastin time); Chemistry (blood urine nitrogen, creatinine, total bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, calcium, gamma-glutyl transpeptidase, phosphorus, uric acid, total protein, glucose, albumin, C-reactive protein); iron status (plasma ferritin, transferrin saturation). Participants with clinically significant change from baseline in laboratory tests were based on investigator's discretion. |
| Number of Participants Who Received Concomitant Medication | Week 1 up to Week 48 | — |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
Participants with chronic renal failure were receiving Epoetin maintenance therapy in study EPOE-10-01 (NCT01473407) prior to enrollment and treatment in the current study.
Participants by arm
| Arm | Count |
|---|---|
| Epoetin Hospira Participants were enrolled to receive Epoetin Hospira intravenous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). | 406 |
| Total | 406 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 33 |
| Overall Study | Kidney Transplant | 9 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Missed Study Drug More than 2 Weeks | 7 |
| Overall Study | Non-compliant with Study Procedures | 10 |
| Overall Study | Not met Inclusion/Exclusion Criteria | 1 |
| Overall Study | Not Treated | 8 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Relocated | 8 |
| Overall Study | Sponsor Decision | 11 |
| Overall Study | Use of Standard of Care | 9 |
| Overall Study | Withdrawal by Subject | 17 |
Baseline characteristics
| Characteristic | Epoetin Hospira |
|---|---|
| Age, Continuous | 57.45 years STANDARD_DEVIATION 12.062 |
| Sex: Female, Male Female | 169 Participants |
| Sex: Female, Male Male | 237 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 277 / 406 |
| serious Total, serious adverse events | 168 / 406 |
Outcome results
Primary
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 13 to 24
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
Time frame: Week 13 up to Week 24
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, ''number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epoetin Hospira | Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 13 to 24 | 57.5 Percentage of participants |
Primary
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 12
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
Time frame: Week 1 up to Week 12
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epoetin Hospira | Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 12 | 59.4 Percentage of participants |
Primary
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 48
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
Time frame: Week 1 up to Week 48
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epoetin Hospira | Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 48 | 85.7 Percentage of participants |
Primary
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 25 to 36
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
Time frame: Week 25 up to Week 36
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epoetin Hospira | Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 25 to 36 | 54.3 Percentage of participants |
Primary
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 37 to 48
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
Time frame: Week 37 up to Week 48
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epoetin Hospira | Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 37 to 48 | 51.7 Percentage of participants |
Primary
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Week 1
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
Time frame: Up through 7 days after first dose of study drug (Week 1)
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epoetin Hospira | Percentage of Participants With Treatment Emergent Adverse Events (AEs): Week 1 | 13.0 Percentage of participants |
Secondary
Mean Hematocrit Levels for Interval of 12 Weeks
Hematocrit is defined as the percentage of red blood cells in the blood.
Time frame: Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48
Population: FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira study drug and had at least 1 Hb value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Epoetin Hospira | Mean Hematocrit Levels for Interval of 12 Weeks | Week 1 to Week 12 | 32.26 Percentage of red blood cells | Standard Deviation 2.695 |
| Epoetin Hospira | Mean Hematocrit Levels for Interval of 12 Weeks | Week 13 to Week 24 | 32.21 Percentage of red blood cells | Standard Deviation 2.569 |
| Epoetin Hospira | Mean Hematocrit Levels for Interval of 12 Weeks | Week 25 to Week 36 | 32.03 Percentage of red blood cells | Standard Deviation 2.978 |
| Epoetin Hospira | Mean Hematocrit Levels for Interval of 12 Weeks | Week 37 to Week 48 | 32.17 Percentage of red blood cells | Standard Deviation 2.738 |
Secondary
Mean Hematocrit Levels: Over Week 1 to 48
Hematocrit is defined as the percentage of red blood cells in the blood.
Time frame: Week 1 up to Week 48
Population: FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira study drug and had at least 1 Hb value. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epoetin Hospira | Mean Hematocrit Levels: Over Week 1 to 48 | 32.17 Percentage of red blood cells | Standard Deviation 2.164 |
Secondary
Mean Hemoglobin Levels for Interval of 12 Weeks
Time frame: Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48
Population: FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira study drug and had at least 1 Hb value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Epoetin Hospira | Mean Hemoglobin Levels for Interval of 12 Weeks | Week 1 to Week 12 | 10.26 g/dL | Standard Deviation 0.789 |
| Epoetin Hospira | Mean Hemoglobin Levels for Interval of 12 Weeks | Week 13 to Week 24 | 10.25 g/dL | Standard Deviation 0.762 |
| Epoetin Hospira | Mean Hemoglobin Levels for Interval of 12 Weeks | Week 25 to Week 36 | 10.18 g/dL | Standard Deviation 0.865 |
| Epoetin Hospira | Mean Hemoglobin Levels for Interval of 12 Weeks | Week 37 to Week 48 | 10.21 g/dL | Standard Deviation 0.818 |
Secondary
Mean Hemoglobin Levels: Over Week 1 to 48
Time frame: Week 1 up to Week 48
Population: FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira study drug and had at least 1 Hb value. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epoetin Hospira | Mean Hemoglobin Levels: Over Week 1 to 48 | 10.21 g/dL | Standard Deviation 0.629 |
Secondary
Mean Weekly Dosage of Epoetin Hospira for Interval of 12 Weeks
Time frame: Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48
Population: FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira study drug and had at least 1 Hb value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Epoetin Hospira | Mean Weekly Dosage of Epoetin Hospira for Interval of 12 Weeks | Week 13 to Week 24 | 94.84 U/kg/week | Standard Deviation 89.303 |
| Epoetin Hospira | Mean Weekly Dosage of Epoetin Hospira for Interval of 12 Weeks | Week 37 to Week 48 | 99.55 U/kg/week | Standard Deviation 95.51 |
| Epoetin Hospira | Mean Weekly Dosage of Epoetin Hospira for Interval of 12 Weeks | Week 1 to Week 12 | 94.93 U/kg/week | Standard Deviation 89.219 |
| Epoetin Hospira | Mean Weekly Dosage of Epoetin Hospira for Interval of 12 Weeks | Week 25 to Week 36 | 94.01 U/kg/week | Standard Deviation 86 |
Secondary
Mean Weekly Dosage of Epoetin Hospira : Over Week 1 to 48
Time frame: Week 1 up to Week 48
Population: Full analysis set (FAS) included all enrolled participants and had at least 1 dose of Epoetin Hospira study drug and had at least 1 Hb value. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epoetin Hospira | Mean Weekly Dosage of Epoetin Hospira : Over Week 1 to 48 | 95.30 Unit per kilogram per week (U/kg/week) | Standard Deviation 85.515 |
Secondary
Percentage of Participants Who Received Blood Transfusions
Time frame: Week 1 up to Week 48
Population: FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira study drug and had at least 1 Hb value.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epoetin Hospira | Percentage of Participants Who Received Blood Transfusions | 9.7 Percentage of participants |
Secondary
Percentage of Participants With Hemoglobin Level Outside the Target Range
Percentage of participants with hemoglobin level outside the target range of 9.0 to 11.0 g/dL were reported.
Time frame: Week 1 up to Week 48
Population: FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira study drug and had at least 1 Hb value.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epoetin Hospira | Percentage of Participants With Hemoglobin Level Outside the Target Range | 90.1 Percentage of participants |
Other Pre-specified
Number of Participants Who Received Concomitant Medication
Time frame: Week 1 up to Week 48
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epoetin Hospira | Number of Participants Who Received Concomitant Medication | 406 Participants |
Other Pre-specified
Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiogram (ECG)
ECG parameters included: PR interval, QRS complex, QT interval and QTC interval. Participants with clinically significant change from baseline in 12-lead ECGs were based on investigator's discretion.
Time frame: Baseline up to Week 48
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epoetin Hospira | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiogram (ECG) | 2 Participants |
Other Pre-specified
Number of Participants With Clinically Significant Change From Baseline in Hemoglobin Levels
Participants with clinically significant change from baseline in hemoglobin levels were upon investigator's discretion.
Time frame: Baseline up to Week 48
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epoetin Hospira | Number of Participants With Clinically Significant Change From Baseline in Hemoglobin Levels | 0 Participants |
Other Pre-specified
Number of Participants With Clinically Significant Change From Baseline in Laboratory Tests
Laboratory tests included: Hematology (hematocrit, hemoglobin, red blood cells count, reticulocytes, white blood cells count, neutrophils, bands, lymphocytes, monocytes, basophils, eosinophils, platelets, mean corpuscular volume); Coagulation panel (prothrombin time, international normalized ratio, activated partial thromboplastin time); Chemistry (blood urine nitrogen, creatinine, total bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, calcium, gamma-glutyl transpeptidase, phosphorus, uric acid, total protein, glucose, albumin, C-reactive protein); iron status (plasma ferritin, transferrin saturation). Participants with clinically significant change from baseline in laboratory tests were based on investigator's discretion.
Time frame: Baseline up to Week 48
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epoetin Hospira | Number of Participants With Clinically Significant Change From Baseline in Laboratory Tests | 0 Participants |
Other Pre-specified
Number of Participants With Clinically Significant Change From Baseline in Physical Examinations
Physical examination included examination of the skin, eyes, ears, nose, throat, head, neck, thyroid, lungs, chest, abdomen, extremities, lymphatic, cardiovascular, musculoskeletal and neurological systems. Participants for any clinically significant changes in physical examination were based on the investigator's discretion.
Time frame: Baseline up to Week 48
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epoetin Hospira | Number of Participants With Clinically Significant Change From Baseline in Physical Examinations | 0 Participants |
Other Pre-specified
Percentage of Participants With Anti-Recombinant Human Erythropoietin (Anti-rhEPO) Antibodies
Percentage of participants with at least 1 positive anti-rhEPO antibody were reported. Radioimmunoprecipitation assay was used to determine the presence of anti-rhEPO antibodies.
Time frame: Baseline, Week 48
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Epoetin Hospira | Percentage of Participants With Anti-Recombinant Human Erythropoietin (Anti-rhEPO) Antibodies | Week 48 | 0.6 Percentage of participants |
| Epoetin Hospira | Percentage of Participants With Anti-Recombinant Human Erythropoietin (Anti-rhEPO) Antibodies | Baseline | 0 Percentage of participants |
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 48
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epoetin Hospira | Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL) | 20.9 Percentage of participants |
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 48
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epoetin Hospira | Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL) | 13.9 Percentage of participants |