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| ID | Type | Description | Link |
|---|---|---|---|
| C3461005 | Other Identifier | Alias Study Number |
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To determine the long term safety in treatment-emergent adverse events (TEAEs) of SC administration of Epoetin Hospira for maintenance of target hemoglobin (Hgb) levels in patients treated for anemia associated with chronic renal failure and on hemodialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epoetin Hospira | Experimental | Epoetin Hospira will be administered by SC bolus injection 1 to 3 times per week per each patient's dosing schedule. Other ESAs (except for long-acting) may be used as rescue therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epoetin Hospira | Biological | Subcutaneous(SC) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up through 7 days after first dose of study drug (Week 1) |
| 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. | Week 1 up to Week 12 |
| 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. | Week 13 up to Week 24 |
| 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. | Week 25 up to Week 36 |
| Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 37 to 48 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL) | Week 1 up to Week 48 | |
| Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL) | Week 1 up to Week 48 |
Inclusion Criteria:
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.
Patient previously completed the core study Maintenance Period up to and including Week 16 study assessments per protocol and is willing to continue open-label Epoetin Hospira for up to 48 weeks.
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:
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.
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:
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.
Any of the following that developed during the core study and prior to enrollment:
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.
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.
A female patient who is pregnant, lactating, or planning a pregnancy during the study.
History of drug abuse or alcohol abuse during the core study prior to enrollment as determined by the Investigator.
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).
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.
Evidence of human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg).
A patient who, in the Investigator's opinion, has any clinically significant abnormal laboratory results that may impact patient safety.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azusa Dialysis Center | Azusa | California | 91702 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32734207 | Derived | Wish JB, Rocha MG, Martin NE, Reyes CRD, Fishbane S, Smith MT, Nassar G. Long-term Safety of Epoetin Alfa-epbx for the Treatment of Anemia in ESKD: Pooled Analyses of Randomized and Open-label Studies. Kidney Med. 2019 Aug 28;1(5):271-280. doi: 10.1016/j.xkme.2019.06.009. eCollection 2019 Sep-Oct. |
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Participants with chronic renal failure were receiving Epoetin maintenance therapy in study EPOE-10-13 (NCT01473420) prior to enrollment and treatment in the current study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Epoetin Hospira | Participants were enrolled to receive Epoetin Hospira subcutaneous 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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.
| Week 37 up to Week 48 |
| 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. | Week 1 up to Week 48 |
| Mean Hemoglobin Levels: Over Week 1 to 48 | Week 1 up to Week 48 |
| 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 Hematocrit Levels: Over Week 1 to 48 | Hematocrit is defined as the percentage of red blood cells in the blood. | Week 1 up to Week 48 |
| Mean Hematocrit Levels for Interval of 12 Weeks | Hematocrit is defined as the percentage of red blood cells in the blood. | Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48 |
| Percentage of Participants With Hemoglobin Level Outside Target Range | Percentage of participants with hemoglobin level outside the target range of 9.0 to 11.0 g/dL were reported. | Week 1 up to Week 48 |
| Percentage of Participants Who Received Blood Transfusions | Week 1 up to Week 48 |
| Number of Participants With Clinically Significant Change From Baseline in Hemoglobin (Hb) Levels | Participants with clinically significant change from baseline in hemoglobin levels were upon investigator's discretion. | Baseline up to Week 48 |
| Number of Participants Who Received Concomitant Medication | Week 1 up to Week 48 |
| 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. | Baseline up to Week 48 |
| 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. | Baseline up to Week 48 |
| Number of Participants With Clinically Significant Change From Baseline in Physical Examinations | Physical examination included examination of the skin, eyes, ears, throat, neck, and cardiac, respiratory, gastrointestinal and musculoskeletal systems. The examination assessed the participants for any clinically significant changes in physical status, as determined by the investigator. | Baseline up to Week 48 |
| Percentage of Participants With Anti-Recombinant Human Erythropoietin (rhEPO) Antibodies | Percentage of participants with at least 1 positive anti-rhEPO antibodies were reported. Radioimmunoprecipitation assay method was used to determine the presence of anti-rhEPO antibodies. | Baseline, Week 48 |
| Azusa |
| California |
| 91702 |
| United States |
| Pegasus Dialysis | Bakersfield | California | 93308 | United States |
| National Institute of Clinical Research | Bakersfield | California | 93309 | United States |
| Bakersfield | California | 93309 | United States |
| Bellflower Dialysis Center | Bellflower | California | 90706 | United States |
| Granada Hills | California | 91344 | United States |
| Lakewood Dialysis Center | Lakewood | California | 90712 | United States |
| Westcoast Dialysis | Long Beach | California | 90806 | United States |
| Long Beach Dialysis | Long Beach | California | 90813 | United States |
| Novo Research | Long Beach | California | 90813 | United States |
| Long Beach | California | 90813 | United States |
| Academic Medical Research Institute | Los Angeles | California | 90022 | United States |
| East LA Dialysis Center | Los Angeles | California | 90022 | United States |
| Los Angeles | California | 90022 | United States |
| Modesto Kidney Center | Modesto | California | 95350 | United States |
| Novo Research, Inc. d/b/a Foundation Research | Modesto | California | 95350 | United States |
| Parkway Kidney Center | Modesto | California | 95350 | United States |
| Modesto | California | 95350 | United States |
| US Renal Care of Northridge | Northridge | California | 91324 | United States |
| Northridge | California | 91324 | United States |
| Norwalk Dialysis Center | Norwalk | California | 90650 | United States |
| Oakdale Kidney Center | Oakdale | California | 95361 | United States |
| US Renal Care of Panorama City | Panorama City | California | 91402 | United States |
| Mohammad Ismail MD, Inc. | Paramount | California | 90723 | United States |
| Paramount Dialysis Center | Paramount | California | 90723 | United States |
| Paramount | California | 90723 | United States |
| Canyon Country Dialysis Center | Santa Clarita | California | 91387 | United States |
| California Kidney Medical Group | Simi Valley | California | 93065 | United States |
| US Renal Care of Van Nuys | Van Nuys | California | 91405 | United States |
| intercommunity Dialysis Center | Whittier | California | 90602 | United States |
| American Institute of Research | Whittier | California | 90603 | United States |
| Whittier Kidney Dialysis Center | Whittier | California | 90603 | United States |
| Whittier | California | 90603 | United States |
| Kidney Center of Arvada | Arvada | Colorado | 80002 | United States |
| Western Nephrology and Metabolic Bone Disease, PC | Arvada | Colorado | 80002 | United States |
| Arvada | Colorado | 80002 | United States |
| Kidney Center of westminster, LLC | Westminster | Colorado | 80031 | United States |
| Western Nephrology and Metabolic Bone Disease, PC | Westminster | Colorado | 80031 | United States |
| Westminster | Colorado | 80031 | United States |
| Pines Clinical Research, Inc. | Pembroke Pines | Florida | 33028 | United States |
| Pembroke Pines | Florida | 33028 | United States |
| Nephrology Centers of America - Augusta (NCA-A) | Augusta | Georgia | 30901 | United States |
| Augusta | Georgia | 30901 | United States |
| Nephrology Centers of America (NCA) South Augusta | Augusta | Georgia | 30906 | United States |
| Kidney Care Associates, LLC | Augusta | Georgia | 30909 | United States |
| Grovetown Dialysis Center | Grovetown | Georgia | 30813 | United States |
| East Macon Dialysis | Macon | Georgia | 31217 | United States |
| Renal Physicians of Georgia, PC | Macon | Georgia | 31217 | United States |
| Macon | Georgia | 31217 | United States |
| Perry Dialysis Center | Perry | Georgia | 31069 | United States |
| Waynesboro Dialysis Center | Waynesboro | Georgia | 30830 | United States |
| Fresenius Medical Care Midtown #8498 | Wichita | Kansas | 67214 | United States |
| Kansas Nephrology Research Institute, LLC | Wichita | Kansas | 67214 | United States |
| Wichita | Kansas | 67214 | United States |
| FMC Northside | Lafayette | Louisiana | 70501 | United States |
| Research Nurse Specialists ,LLC | Lafayette | Louisiana | 70503 | United States |
| Lafayette | Louisiana | 70506 | United States |
| FMC Opelousas | Opelousas | Louisiana | 70570 | United States |
| Fresenius Medical Care- Kalamazoo East | Kalamazoo | Michigan | 49001 | United States |
| Fresenius Medical Care - Kalamazoo | Kalamazoo | Michigan | 49007 | United States |
| Nephrology Center DBA Paragon Health PC | Kalamazoo | Michigan | 49007 | United States |
| Kalamazoo | Michigan | 49007 | United States |
| Fresenius Medical Care - Oshtermo | Kalamazoo | Michigan | 49009 | United States |
| Fresenius Medical Care- Gull Road | Kalamazoo | Michigan | 49048 | United States |
| Belton | Missouri | 64012 | United States |
| Dialysis Clinics, Inc. - Belton | Belton | Missouri | 66012 | United States |
| FMC Metro North Dialysis | Florissant | Missouri | 63033 | United States |
| FMC Normandy Dialysis | Normandy | Missouri | 63121 | United States |
| FMC St. Louis Regional Dialysis | Saint Ann | Missouri | 63074 | United States |
| Metro Hypertension and Kidney Center | St Louis | Missouri | 63136 | United States |
| St Louis | Missouri | 63136 | United States |
| Dialysis Clinic Incorporated | North Brunswick | New Jersey | 08902 | United States |
| North Brunswick | New Jersey | 08902 | United States |
| Kennedy Dialysis Center | Sewell | New Jersey | 08080 | United States |
| Kennedy Dialysis Center | Voorhees Township | New Jersey | 08043 | United States |
| Voorhees Township | New Jersey | 08043 | United States |
| College Point | New York | 11356 | United States |
| Flushing | New York | 11355 | United States |
| Trude Weishaupt Memorial Dialysis Center | Fresh Meadows | New York | 11365 | United States |
| Wake Dialysis Clinic | Raleigh | North Carolina | 27609 | United States |
| Wake Nephrology Associates, PA | Raleigh | North Carolina | 27609 | United States |
| Raleigh | North Carolina | 27609 | United States |
| DCI McMillan | Cincinnati | Ohio | 45206 | United States |
| Cincinnati | Ohio | 45267 | United States |
| Innovative Dialysis of Toledo | Toledo | Ohio | 43606 | United States |
| Toledo Hospital, Promedica Health System | Toledo | Ohio | 43606 | United States |
| Toledo | Ohio | 43606 | United States |
| Alexis Dialysis Center | Toledo | Ohio | 43613 | United States |
| Wildwood Dialysis Center | Toledo | Ohio | 43615 | United States |
| meadville Dialysis | Meadville | Pennsylvania | 16335 | United States |
| The Center for Hypertension and Nephrology Care | Meadville | Pennsylvania | 16335 | United States |
| Fresenius Medical Care | Knoxville | Tennessee | 37921 | United States |
| Cedar Bluff Dialysis | Knoxville | Tennessee | 37923 | United States |
| Knoxville Kidney Center, PLLC | Knoxville | Tennessee | 37923 | United States |
| Knoxville | Tennessee | 37923 | United States |
| Fresenius Medical Care-Austin North Dialysis | Austin | Texas | 78758 | United States |
| Research Management Inc. | Austin | Texas | 78758 | United States |
| Research Management, Inc. | Austin | Texas | 78758 | United States |
| Austin | Texas | 78758 | United States |
| Fresenius Medical Care - Cedar Park | Cedar Park | Texas | 78613 | United States |
| Grand Prairie Dialysis Center | Grand Prairie | Texas | 75051 | United States |
| Grand Prairie | Texas | 75051 | United States |
| Mission Bend Dialysis | Houston | Texas | 77083 | United States |
| Southwest Houston Research, Ltd. | Houston | Texas | 77099 | United States |
| Houston | Texas | 77099 | United States |
| SNG Dialysis Center of Lufkin | Lufkin | Texas | 75904 | United States |
| Lufkin | Texas | 75904 | United States |
| San Antonio Kidney Disease Center Physicians Group, P.L.L.C. | San Antonio | Texas | 78229 | United States |
| Las Palmas Davita Dialysis Center | San Antonio | Texas | 78237 | United States |
| San Antonio | Texas | 78237 | United States |
| ARA Mechanicsville Dialysis | Mechanicsville | Virginia | 23116 | United States |
| Nephrology Specialists, P.C. | Mechanicsville | Virginia | 23116 | United States |
| Mechanicsville | Virginia | 23116 | United States |
| ARA South Laburnum Dialysis | Richmond | Virginia | 23231 | United States |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira.
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| ID | Title | Description |
|---|---|---|
| BG000 | Epoetin Hospira | Participants were enrolled to receive Epoetin Hospira subcutaneous 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | Percentage of participants | Up through 7 days after first dose of study drug (Week 1) |
|
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| 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. | Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira. | Posted | Number | Percentage of participants | Week 1 up to Week 12 |
|
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| 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. | Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | Percentage of participants | Week 13 up to Week 24 |
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| 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. | Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | Percentage of participants | Week 25 up to Week 36 |
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| 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. | Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | Percentage of participants | Week 37 up to Week 48 |
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| 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. | Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira. | Posted | Number | Percentage of participants | Week 1 up to Week 48 |
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| Secondary | Mean Weekly Dosage of Epoetin Hospira: Over Week 1 to 48 | Full analysis set (FAS) included all enrolled participants and had at least 1 dose of Epoetin Hospira and had at least 1 Hb value. | Posted | Mean | Standard Deviation | Unit per kilogram per week (U/kg/week) | Week 1 up to Week 48 |
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| Secondary | Mean Weekly Dosage of Epoetin Hospira for Interval of 12 Weeks | FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira and had at least 1 Hb value. Here, 'n' signifies those participants who were evaluable at specified time points. | Posted | Mean | Standard Deviation | U/kg/week | Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48 |
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| Secondary | Mean Hemoglobin Levels: Over Week 1 to 48 | FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira and had at least 1 Hb value. | Posted | Mean | Standard Deviation | g/dL | Week 1 up to Week 48 |
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| Secondary | Mean Hemoglobin Levels for Interval of 12 Weeks | FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira and had at least 1 Hb value. Here, 'n' signifies those participants who were evaluable at specified time points. | Posted | Mean | Standard Deviation | g/dL | Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48 |
|
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| Secondary | Mean Hematocrit Levels: Over Week 1 to 48 | Hematocrit is defined as the percentage of red blood cells in the blood. | FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira and had at least 1 Hb value. | Posted | Mean | Standard Deviation | Percentage of red blood cells | Week 1 up to Week 48 |
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| Secondary | Mean Hematocrit Levels for Interval of 12 Weeks | Hematocrit is defined as the percentage of red blood cells in the blood. | FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira and had at least 1 Hb value. Here, 'n' signifies those participants who were evaluable at specified time points. | Posted | Mean | Standard Deviation | Percentage of red blood cells | Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48 |
|
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| Secondary | Percentage of Participants With Hemoglobin Level Outside Target Range | Percentage of participants with hemoglobin level outside the target range of 9.0 to 11.0 g/dL were reported. | FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira and had at least 1 Hb value. | Posted | Number | Percentage of participants | Week 1 up to Week 48 |
|
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| Secondary | Percentage of Participants Who Received Blood Transfusions | FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira and had at least 1 Hb value. | Posted | Number | Percentage of participants | Week 1 up to Week 48 |
|
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| Other Pre-specified | Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL) | Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | Percentage of participants | Week 1 up to Week 48 |
|
| ||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL) | Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | Percentage of participants | Week 1 up to Week 48 |
|
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| Other Pre-specified | Number of Participants With Clinically Significant Change From Baseline in Hemoglobin (Hb) Levels | Participants with clinically significant change from baseline in hemoglobin levels were upon investigator's discretion. | Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira. | Posted | Number | Participants | Baseline up to Week 48 |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants Who Received Concomitant Medication | Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira. | Posted | Number | Participants | Week 1 up to Week 48 |
|
| ||||||||||||||||||||||||||||
| 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. | Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira. | Posted | Number | Participants | Baseline up to Week 48 |
|
| |||||||||||||||||||||||||||
| 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. | Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira. | Posted | Number | Participants | Baseline up to Week 48 |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Clinically Significant Change From Baseline in Physical Examinations | Physical examination included examination of the skin, eyes, ears, throat, neck, and cardiac, respiratory, gastrointestinal and musculoskeletal systems. The examination assessed the participants for any clinically significant changes in physical status, as determined by the investigator. | Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira. | Posted | Number | Participants | Baseline up to Week 48 |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With Anti-Recombinant Human Erythropoietin (rhEPO) Antibodies | Percentage of participants with at least 1 positive anti-rhEPO antibodies were reported. Radioimmunoprecipitation assay method was used to determine the presence of anti-rhEPO antibodies. | Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira. Here, "n" signifies those participants who were evaluable at specified time points. | Posted | Number | Percentage of participants | Baseline, Week 48 |
|
|
Not provided
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Epoetin Hospira | Participants were enrolled to receive Epoetin Hospira subcutaneous 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). | 59 | 170 | 127 | 170 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Bundle branch block left | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Mitral valve stenosis | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Nodal rhythm | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Optic neuropathy | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Diabetic gastroparesis | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Oesophagitis ulcerative | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Rectal fissure | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Arteriovenous graft site infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Enterococcal bacteraemia | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Streptococcal sepsis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Arteriovenous fistula site haemorrhage | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Vascular graft complication | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Vascular graft thrombosis | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Calciphylaxis | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment | This is a gender specific event. |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| VIIth nerve paralysis | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Vascular graft complication | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single centre publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer, Inc. | Pfizer ClinicalTrials.gov Call Center | 1--800--718--1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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