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| ID | Type | Description | Link |
|---|---|---|---|
| C3461003 | Other Identifier | Alias Study Number |
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| Name | Class |
|---|---|
| Hospira, now a wholly owned subsidiary of Pfizer | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epoetin Hospira | Experimental | Epoetin Hospira |
|
| Epogen (Amgen) | Active Comparator | Epogen (Amgen) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epoetin Hospira | Biological | Variable dose |
| |
| Epogen Amgen |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL): Maintenance Period | Week 19 up to Week 34 | |
| Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL): Maintenance Period | Week 19 up to Week 34 |
Inclusion Criteria:
Patient is able to provide written informed consent after risks and benefits of the study have been explained prior to any study related activities
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:
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
Patients with adequate iron stores, defined as plasma ferritin > 100 μg/L and TSAT >20%, prior to randomization
Male or female patients aged 18 to 80 years (both inclusive)
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:
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:
Maintenance epoetin dosage >600 U/kg per week (1-3 times per week)
Treatment with long-acting epoetin analogues such as Aranesp ® within 12 weeks prior to randomization
Any of the following within 3 months prior to randomization:
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
Known, clinically manifested deficiency of folic acid and/or vitamin B12 (irrespective of whether currently treated or not)
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
Contraindication for the test drug or have been previously treated with Epoetin Hospira
Relative or absolute iron deficiency prior to randomization into the Maintenance Period
Platelet count below 100 x 10^9/L
Clinically relevant increase of CRP (>10 mg/dL) for at least 2 weeks
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
History of any of the following:
A female patient who is pregnant, lactating or planning a pregnancy during the study
History of drug abuse or alcohol abuse within 2 years prior to randomization as determined by the Investigator
Current participation or participation in a drug or other investigational research study within 30 days prior to randomization
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
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
A patient who in the Investigator's opinion, has any clinically significant abnormal laboratory evaluations, including liver function taken at Screening Visit
Positive laboratory test for human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg)
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North America Research Institute | Azusa | California | 91702 | United States | ||
| National Institute of Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36791280 | Derived | Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3. | |
| 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 prior to enrollment and treatment in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Titration Period (18 Weeks) |
|
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| Biological |
Variable dose |
|
|
| 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. | Week 19 up to Week 34 |
| 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. | Week 26, 34 |
| 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 | Percentage of participants who had hemoglobin level outside the target range of 9 to 11 g/dL for the specified weeks were reported. | Week 26, 34 |
| 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 | 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 | Week 19 up to Week 34 |
| 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 |
| 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. | Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38 |
| 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). | Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38 |
| Number of Participants With Treatment Related Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant who received study drug. | Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38 |
| 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. | Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38 |
| 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. | 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 |
| 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. | 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 |
| 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. | 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 |
| 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. | 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 |
| 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. | Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38 |
| 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. | Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38 |
| 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. | Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38 |
| Bakersfield |
| California |
| 93309 |
| United States |
| Long Beach Dialysis Center | Long Beach | California | 90813 | United States |
| Academic Medical Research Institute | Los Angeles | California | 90022 | United States |
| Long Beach Dialysis Center | Modesto | California | 95350 | United States |
| Innovative Dialysis Center of Northridge, LLC | Northridge | California | 91324 | United States |
| Valley Renal Medical Group | Northridge | California | 91324 | United States |
| Research Management Inc. | Paramount | California | 90723 | United States |
| Pleasanton Dialysis Center | Pleasanton | California | 94588 | United States |
| Sunset Dialysis Center | Rancho Cordova | California | 95670 | United States |
| Capital Nephrology Medical Group | Sacramento | California | 95825 | United States |
| Chabot Nephrology Medical Group | San Leandro | California | 94578 | United States |
| San Leandro Dialysis | San Leandro | California | 94578 | United States |
| Renal Consultants Medical Group | Santa Clarita | California | 91387 | 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 |
| Western Nephrology and Metabolic Bone Disease, PC | 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 |
| Pines Clinical Research Inc. | Pembroke Pines | Florida | 33028 | United States |
| Dialysis Clinic, Inc. - Albany | Albany | Georgia | 31701-2057 | United States |
| Kidney Care Associates | Augusta | Georgia | 30909 | United States |
| Renal Physicians of Georgia, PC | Dublin | Georgia | 31021 | United States |
| Neomedica Marquette Park | Chicago | Illinois | 60636 | United States |
| Research by Design, LLC | Evergreen Park | Illinois | 60805 | United States |
| Kansas Nephrology Physicians, PA | Wichita | Kansas | 67214 | United States |
| Research Nurse Specialists, LLC | Lafayette | Louisiana | 70503 | United States |
| New York Harbor Health Care System | Lafayette | Louisiana | 70506 | United States |
| Westbank Nephrology Associates | Marrero | Louisiana | 70072 | United States |
| FMC Opelousas | Opelousas | Louisiana | 70570 | United States |
| Northwest Louisiana Nephrology | Shreveport | Louisiana | 71101 | 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 |
| Fresenius Medical Care-Oshtemo | Kalamazoo | Michigan | 49009 | United States |
| Fresenius Medical Care-Gull Road | Kalamazoo | Michigan | 49048 | United States |
| Clinical Research Consultants, LLC | Kansas City | Missouri | 64111 | United States |
| Kansas City Renal Center | Kansas City | Missouri | 64111 | United States |
| Renal Advantage, Inc. | Kansas City | Missouri | 64131 | United States |
| Metro Hypertension and Kidney Center | St Louis | Missouri | 63136 | United States |
| University of Cincinnati College of Medicine. | North Brunswick | New Jersey | 08902 | United States |
| Nephrology & Hypertension Associates of NJ | Voorhees Township | New Jersey | 08043 | United States |
| Newtown Dialysis Center | Astoria | New York | 11102 | United States |
| New York Hospital Medical Center Queens Institutional Review Board | Flushing | New York | 11355 | United States |
| Parker Jewish Institute for Health Care and Rehabilitation | New Hyde Park | New York | 11040 | United States |
| New York Harbor Health Care System | New York | New York | 10010 | United States |
| Wake Nephrology Associates, PA | Raleigh | North Carolina | 27609 | United States |
| University of Cincinnati College of Medicine | Cincinnati | Ohio | 45267 | United States |
| Private Practice of Kenneth Lempert | Toledo | Ohio | 43606 | United States |
| Northwest Physicians Associates, PC | Meadville | Pennsylvania | 16335 | United States |
| CSRA Renal Services, LLC | Aiken | South Carolina | 29801 | United States |
| Fresenius Medical Care Midtown JV | Columbia | South Carolina | 29201 | United States |
| Columbia Nephrology Associates, PA | Columbia | South Carolina | 29203 | United States |
| Fresenius Medical Care Irmo JV | Irmo | South Carolina | 29063 | United States |
| South Carolina Nephrology and Hypertension Center, Inc. | Orangeburg | South Carolina | 29118 | United States |
| Knoxville Kidney Center, PLLC | 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 |
| Dallas Veterans Affairs Medical Center | Dallas | Texas | 75216 | United States |
| Grand Prairie Dialysis Center | Grand Prairie | Texas | 75051 | United States |
| Research Across America | Houston | Texas | 77054 | United States |
| Westminster Dialysis | Houston | Texas | 77077 | United States |
| Mission Bend Dialysis | Houston | Texas | 77083 | United States |
| Southwest Houston Research, Ltd. | Houston | Texas | 77099 | United States |
| East Texas Nephrology Associates | Lufkin | Texas | 75904 | United States |
| San Antonio Kidney Disease Center | San Antonio | Texas | 78229 | United States |
| Renal Care Partners of Pentagon City | Arlington | Virginia | 22206 | United States |
| Clinical Research and Consulting Center, LLC | Fairfax | Virginia | 22030 | United States |
| Renal Care Partners of Fairfax | Fairfax | Virginia | 22030 | United States |
| Nephrology Specialists, PC | Mechanicsville | Virginia | 23116 | United States |
| Western Institutional Review Board | Olympia | Washington | 98502 | United States |
| FG001 | 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). |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Maintenance Period (16 Weeks) |
|
|
Analysis population included all participants who were enrolled.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Mean Weekly Hemoglobin Level From Week 30 to Week 34: Maintenance Period | 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. | Posted | Mean | Standard Deviation | g/dL | Week 30 up to Week 34 |
|
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Mean Weekly Dosage of Study Medication From Week 30 to Week 34: Maintenance Period | This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period. | Posted | Mean | Standard Deviation | unit per kilogram per week (U/kg/week) | Week 30 up to Week 34 |
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| Secondary | Mean Weekly Hemoglobin Level From Week 19 to Week 34: Maintenance Period | 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. | Posted | Mean | Standard Deviation | g/dL | Week 19 up to Week 34 |
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| Secondary | Mean Weekly Dosage of Study Medication From Week 19 to Week 34: Maintenance Period | 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. | Posted | Mean | Standard Deviation | U/kg/week | Week 19 up to Week 34 |
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| 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. | 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. | Posted | Mean | Standard Deviation | units of study medication | Week 19 up to Week 34 |
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| 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. | This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period. | Posted | Number | percentage of participants | Week 26, 34 |
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| Secondary | Percentage of Participants Who Required Permanent Dose Changes: Maintenance Period | 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. | Posted | Number | percentage of participants | Week 19 up to Week 34 |
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| Secondary | Percentage of Participants Who Required Temporary Dose Changes: Maintenance Period | 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. | Posted | Number | percentage of participants | Week 19 up to Week 34 |
|
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| Secondary | Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 1.0 Gram Per Deciliter (g/dL): Maintenance Period | 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. | Posted | Number | percentage of participants | Week 19 up to Week 34 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period. | Posted | Number | percentage of participants | Week 26, 34 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Qualified as Optimally Titrated and Stable: Titration Period | 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. | Posted | Number | percentage of participants | Week 1 up to Week 18 |
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| Secondary | Percentage of Participants Who Received Blood Transfusions: Maintenance Period | This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period. | Posted | Number | percentage of participants | Week 19 up to Week 34 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | 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. | Posted | Count of Participants | Participants | Week 19 up to Week 34 |
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| 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 | 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. | Posted | Number | percentage of participants | Week 19 up to Week 34 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL): Maintenance Period | 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. | Posted | Number | percentage of participants | Week 19 up to Week 34 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL): Maintenance Period | 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. | Posted | Number | percentage of participants | Week 19 up to Week 34 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Safety population included all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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). | 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. | Posted | Count of Participants | Participants | Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Count of Participants | Participants | Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Count of Participants | Participants | Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Safety population included all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | 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 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Safety population included all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | 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 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Safety population included all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | 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 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Safety population included all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | 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 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | percentage of participants | Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | percentage of participants | Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | percentage of participants | Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38 |
|
Not provided
Same event may appear as both AE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious 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: Titration Period | During titration period participants who were on Epogen IV regimen prior to this study, were titrated and optimally stabilized to receive 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 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). | 12 | 80 | 16 | 80 | ||
| EG001 | Epogen: Titration Period | 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). | 22 | 86 | 10 | 86 | ||
| EG002 | Epoetin Hospira: Maintenance Period | During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the 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 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). | 23 | 122 | 27 | 122 | ||
| EG003 | Epogen: Maintenance Period | During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the 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 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). | 33 | 122 | 24 | 122 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Haemorrhagic Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Angina Unstable | Cardiac 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 |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cardiac Perforation | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Colitis Ischaemic | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Food Poisoning | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Gastroduodenitis | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Impaired Gastric Emptying | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Arteriovenous Fistula Occlusion | 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 |
| |
| Graft Haemorrhage | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Humerus Fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Multiple Fractures | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Tibia Fracture | 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 |
| |
| Blood Culture Positive | Investigations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Fluid Overload | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Osteoarthritis | 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 |
| |
| Carcinoid Tumour Of The Stomach | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
| |
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
| |
| Multiple Myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
| |
| Non-Small Cell Lung Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cervical Cord Compression | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hepatic Encephalopathy | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Mental Impairment | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Presyncope | 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 |
| |
| Azotaemia | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Renal Cyst Haemorrhage | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Decubitus Ulcer | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Aortic Stenosis | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Jugular Vein Thrombosis | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Orthostatic Hypotension | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Vena Cava Thrombosis | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Supraventricular Tachycardia | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Gastrointestinal Angiodysplasia | Congenital, familial and genetic disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Colon Gangrene | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Graft Infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Necrotising Fasciitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Oesophageal Candidiasis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pyelonephritis Acute | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Arteriovenous Fistula Site Complication | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Graft Thrombosis | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Limb Traumatic Amputation | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment | This event was gender specific. |
|
| Vulval Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment | This event was gender specific. |
|
| Vulval Cancer Stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment | This event was gender specific. |
|
| Metabolic Encephalopathy | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 14.1 | Non-systematic Assessment | This event was gender specific. |
|
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Atelectasis | 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 |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Aneurysm Ruptured | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypertensive Crisis | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Injection Site Pain | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Procedural Hypotension | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Eosinophil Count Increased | Investigations | 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 center 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 ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068817 | Epoetin Alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
Not provided
Not provided
| Did not meet criteria |
|
| Kidney transplant |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Site closure |
|
| Started Peritoneal Dialysis |
|
| Long term hospitalization |
|
| Sponsor's Decision |
|
| Elevated Hemoglobin |
|
| >=65 years |
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| Epogen: Titration Period |
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). |
| OG002 | Epoetin Hospira: Maintenance Period | During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the 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 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). |
| OG003 | Epogen: Maintenance Period | During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the 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 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). |
|
|
| OG001 |
| Epogen: Titration Period |
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). |
| OG002 | Epoetin Hospira: Maintenance Period | During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the 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 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). |
| OG003 | Epogen: Maintenance Period | During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the 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 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). |
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| OG002 | Epoetin Hospira: Maintenance Period | During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the 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 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). |
| OG003 | Epogen: Maintenance Period | During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the 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 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). |
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| OG002 | Epoetin Hospira: Maintenance Period | During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the 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 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). |
| OG003 | Epogen: Maintenance Period | During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the 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 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). |
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| OG001 | Epogen: Titration Period | 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). |
| OG002 | Epoetin Hospira: Maintenance Period | During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the 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 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). |
| OG003 | Epogen: Maintenance Period | During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the 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 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). |
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| OG002 | Epoetin Hospira: Maintenance Period | During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the 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 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). |
| OG003 | Epogen: Maintenance Period | During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the 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 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). |
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| OG002 | Epoetin Hospira: Maintenance Period | During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the 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 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). |
| OG003 | Epogen: Maintenance Period | During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the 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 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). |
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| OG002 | Epoetin Hospira: Maintenance Period | During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the 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 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). |
| OG003 | Epogen: Maintenance Period | During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the 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 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). |
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| OG002 | Epoetin Hospira: Maintenance Period | During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the 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 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). |
| OG003 | Epogen: Maintenance Period | During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the 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 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). |
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| OG002 | Epoetin Hospira: Maintenance Period | During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the 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 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). |
| OG003 | Epogen: Maintenance Period | During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the 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 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). |
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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).
| OG002 | Epoetin Hospira: Maintenance Period | During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the 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 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). |
| OG003 | Epogen: Maintenance Period | During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the 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 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). |
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