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| ID | Type | Description | Link |
|---|---|---|---|
| C3461001 | 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 IV Epoetin Hospira compared to IV Epogen (Amgen), based on maintenance of Hb levels and study drug dose requirements in patients treated for anemia associated with chronic renal failure and on hemodialysis.
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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 21 to Week 24 | Week 21 up to Week 24 | |
| Mean Weekly Dosage of Study Medication From Week 21 to Week 24 | Week 21 up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Weekly Hemoglobin Level Through 24 Weeks | Week 1 up to Week 24 | |
| Mean Weekly Dosage of Study Medication Through 24 Weeks | Week 1 up to Week 24 | |
| Total Dose of Study Medication Administered |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL) | Week 1 up to Week 24 | |
| Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL) | Week 1 up to Week 24 |
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) treatment for at least 4 weeks prior to randomization, for whom the following apply (during this period):
Epogen (Amgen) dose has been administered intravenously 1 to 3 times per week with no more than a 10% dose change from the mean for at least 4 weeks prior to randomization
Stable hemoglobin, defined as meeting all of the following:
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 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 either postmenopausal for at least 1 year prior to randomization, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or practicing at least 1 of the following methods of birth control:
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 3 months 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 (including demyelinating diseases such as multiple sclerosis) that in the Investigator's opinion may be significant to exclude participation in the study, including but not limited to microbial, viral, or fungal infection or mental disease
Contraindication for the test drug or have been previously treated with Epoetin Hospira
Relative or absolute iron deficiency prior to randomization
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 |
|---|---|---|---|---|---|---|
| Montgomery Kidney Specialists | Montgomery | Alabama | 36106 | United States | ||
| Southwest Clinical Research Institute, LLC |
| 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 | Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Biological |
Variable dose |
|
|
| Week 1 up to Week 24 |
| Percentage of Participants With Mean Weekly Hemoglobin Level Within the Target Range | Percentage of participants who had hemoglobin level within the target range of 9 to 11 g/dL for the specified weeks were reported. | Week 12, 24 |
| Percentage of Participants Who Required Permanent Dose Changes of Study Medication | Week 1 up to Week 24 |
| Percentage of Participants Who Required Temporary Dose Changes of Study Medication | Week 1 up to Week 24 |
| Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 1 Gram Per Deciliter (g/dL) | Week 1 up to Week 24 |
| Percentage of Participants With Mean Weekly Hemoglobin Level Outside the Target Range | Percentage of participants who had hemoglobin level outside the target range of 9 to 11 g/dL for the specified weeks were reported. | Week 12, 24 |
| Percentage of Participants Who Received Blood Transfusions | Week 1 up to Week 24 |
| Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level | 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 1 up to Week 24 |
| Percentage of Participants With Any Transient Change of Hemoglobin Greater Than (>) 2.0 Gram Per Deciliter (g/dL) in Hemoglobin Level | Week 1 up to Week 24 |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged in-patient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events from first dose of study drug to the end of study (up to Week 28) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events. | Week 1 up to Week 28 |
| Number of Participants With Treatment-Emergent Adverse Events by Severity | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug to the end of study (up to Week 28) that were absent before treatment or that worsened relative to pre-treatment state. An AE was assessed according to severity; mild (AE was transient and easily tolerated by the participant), moderate (caused problem that did not interfere significantly with usual activities) and severe (caused problem that interferes significantly with usual activities and might be incapacitating or life-threatening). | Week 1 up to Week 28 |
| Number of Participants With Treatment Related Adverse Events (AEs) | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. | Week 1 up to Week 28 |
| Number of Participants That Discontinued Treatment Due to a Treatment Emergent Adverse Event | In this outcome measure number of participants who discontinued from study drug (Epoetin Hospira, Epogen) due to any AE were reported. | Week 1 up to Week 28 |
| 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. | Baseline up to Week 28 |
| 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. | Baseline up to Week 28 |
| 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. | Baseline up to Week 28 |
| 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. | Baseline up to Week 28 |
| 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. | Week 1 up to Week 28 |
| Tempe |
| Arizona |
| 85284 |
| United States |
| Lakhi M. Sakhrani, MD A Medical Coporation | Alhambra | California | 91801 | United States |
| North America Research Institute | Azusa | California | 91702 | United States |
| DaVita Dialysis Center-Bakersfield Dialysis Center | Bakersfield | California | 93309 | United States |
| Ong, Rubin, Shahmir A Medical Corp DBA: Solano Kidney Care | Fairfield | California | 94533 | United States |
| A Medical Corporation | Glendale | California | 91204 | United States |
| Renal Consultants Medical Group | Granada Hills | California | 91344 | United States |
| La Puente Dialysis Center | La Puente | California | 91744 | United States |
| Advanced Medical Research, LLC | Lakewood | California | 90712 | United States |
| DaVita Bixby Knolls Dialysis | Long Beach | California | 90807 | United States |
| Bayview Nephrology, Inc | Long Beach | California | 90813 | United States |
| Academic Medical Research Institute | Los Angeles | California | 90022 | United States |
| Desert Nephrology Medical Group | Modesto | California | 95350 | United States |
| La Jolla Clinical Research, Inc. | National City | California | 91950 | United States |
| Valley Renal Medical Group | Northridge | California | 91324 | United States |
| Ontario Dialysis Inc | Ontario | California | 91762 | United States |
| Discovery medical Research Group, Inc. | Porterville | California | 93257 | United States |
| Nephrology Educational Services and Research, Inc | Tarzana | California | 91356 | United States |
| Queen Dialysis Center | West Covina | California | 91790 | United States |
| American Institute of Research | Whittier | California | 90603 | United States |
| Mark C. Lee, Inc. Santa Fe Springs Dialysis | Whittier | California | 90606 | United States |
| North Valley Nephrology | Yuba City | California | 95991 | United States |
| Nephrology and Hypertension Associates | Middlebury | Connecticut | 06762 | United States |
| South Florida Nephrology, Inc. | Coral Springs | Florida | 33071 | United States |
| South Florida Research Institute | Lauderdale Lakes | Florida | 33313 | United States |
| San Marcus Research Clinic, Inc | Miami | Florida | 33015 | United States |
| Nephrology Associates of South Miami | Miami | Florida | 33173 | United States |
| ARA Naples South Dialysis Center | Naples | Florida | 34112-6703 | United States |
| ARA- Naples Dialysis Center, LLC | Naples | Florida | 34119 | United States |
| Innovative Medical Research of South Florida, Inc. | North Miami Beah | Florida | 33169 | United States |
| Discovery Medical Research Group, Inc. | Ocala | Florida | 34471 | United States |
| Central Florida Kidney Centers | Orlando | Florida | 32801-3621 | United States |
| Renal Physicians of Georgia, PC | Dublin | Georgia | 31021 | United States |
| Boise Kidney & Hypertension Institute, PLLC | Meridian | Idaho | 83642 | United States |
| Research by Design, LLC | Evergreen Park | Illinois | 60805 | United States |
| North Suburban Nephrology, LLC | Gurnee | Illinois | 60031 | United States |
| Nephrology Specialists, PC | Merrillville | Indiana | 46410 | United States |
| Westbank Nephrology Associates | Marrero | Louisiana | 70072 | United States |
| Internal Medicine Specialists | New Orleans | Louisiana | 70115 | United States |
| Northwest Louisiana Nephrology | Shreveport | Louisiana | 71101 | United States |
| DaVita Dialysis Centers | Clinton Township | Michigan | 48038 | United States |
| St. Clair Specialty Physicians, P.C. | Detroit | Michigan | 48236 | United States |
| South Mississippi Medical Research, PLLC | Gulfport | Mississippi | 39501 | United States |
| Chromalloy American Kidney Center | St Louis | Missouri | 63110 | United States |
| Kidney Specialists of Southern Nevada | Las Vegas | Nevada | 89106 | United States |
| Hypertension & Nephrology Associates | Eatontown | New Jersey | 07724 | United States |
| Brookdale Physician Dialysis Associates | Brooklyn | New York | 11212 | United States |
| Lower Manhattan Dialysis Center | New York | New York | 10016 | United States |
| Mountain Kidney and Hypertension Associates, PA | Asheville | North Carolina | 28801 | United States |
| East Carolina University, ECU School of Medicine, Department of Internal Medicine | Greenville | North Carolina | 27834 | United States |
| Eastern Nephrology Associates, PLLC | New Bern | North Carolina | 28562 | United States |
| Brookview Hills Research Associates, LLC | Winston-Salem | North Carolina | 27103 | United States |
| Cincinnati VA Medical Center | Cincinnati | Ohio | 45220 | United States |
| HNC Dialysis Ltd. | Columbus | Ohio | 43215 | United States |
| Bayview Nephrology, Inc | Erie | Pennsylvania | 16507 | United States |
| DaVita-Erie Dialysis Center | Erie | Pennsylvania | 16507 | United States |
| UPMC Hamot Clinical Trials Department | Erie | Pennsylvania | 16507 | United States |
| Franklin Dialysis Center | Philadelphia | Pennsylvania | 19106 | United States |
| Delaware Valley Nephrology and Hypertension Associates, PC | Philadelphia | Pennsylvania | 19118 | United States |
| Nephrology and Internal Medicine of Anderson | Anderson | South Carolina | 29621 | United States |
| Columbia Nephrology Associates, P.A. | Columbia | South Carolina | 29203 | United States |
| Columbia Nephrology Associates, PA | Columbia | South Carolina | 29203 | United States |
| Palmetto Nephrology, PA | Orangeburg | South Carolina | 29118 | United States |
| South Carolina Nephrology and Hypertension Center, Inc. | Orangeburg | South Carolina | 29118 | United States |
| Desert Nephrology Medical Group | Sumter | South Carolina | 29150 | United States |
| Southeast Renal Research Institute | Chattanooga | Tennessee | 37404 | United States |
| South Arlington Dialysis Center | Arlington | Texas | 76015 | United States |
| Texas Renal Care | Greenville | Texas | 75402 | United States |
| Med Center Dialysis | Houston | Texas | 77004 | United States |
| Meyerland Dialysis | Houston | Texas | 77035 | United States |
| Millenium Clinical Research, Inc. | Houston | Texas | 77054-11801 | United States |
| Millennium Clinical Research, Inc. | Houston | Texas | 77054-11801 | United States |
| Research Across America | Houston | Texas | 77054 | United States |
| Southwest Houston Dialysis | Houston | Texas | 77071 | United States |
| Southwest Houston Research, Ltd. | Houston | Texas | 77099 | United States |
| Texas Tech University Health Sciences Center | Lubbock | Texas | 79430 | United States |
| Private practice of Roberto Mangoo-Karim MD | McAllen | Texas | 78503 | United States |
| Missouri City Dialysis | Missouri City | Texas | 77489 | United States |
| San Antonio Kidney Disease Center Physicians Group, P.L.L.C. | San Antonio | Texas | 78229 | United States |
| DaVita Dialysis Center-Floyd Curl Dialysis | San Antonio | Texas | 78240 | United States |
| Clinical Research and Consulting Center, LLC | Fairfax | Virginia | 22030 | United States |
| Peninsula Kidney Associates | Hampton | Virginia | 23666 | United States |
| Internal Medicine Kidney and Hypertension Center | Norfolk | Virginia | 23502 | United States |
| Consolidated Medical Plaza | Caguas | 00725 | Puerto Rico |
| Epogen |
Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) population included all participants who were randomized to study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Epoetin Hospira | Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28. |
| BG001 | Epogen | Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28. |
| 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, 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 | Mean Weekly Hemoglobin Level From Week 21 to Week 24 | ITT population included all participants who were randomized to study treatment. | Posted | Mean | Standard Deviation | g/dL | Week 21 up to Week 24 |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Mean Weekly Dosage of Study Medication From Week 21 to Week 24 | ITT population included all participants who were randomized to study treatment. Here, "Number of Participants Analyzed (N)" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | unit per kilogram per week (U/kg/week) | Week 21 up to Week 24 |
|
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| Secondary | Mean Weekly Hemoglobin Level Through 24 Weeks | ITT population included all participants who were randomized to study treatment. Here, "N" signifies number of participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | g/dL | Week 1 up to Week 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Weekly Dosage of Study Medication Through 24 Weeks | ITT population included all participants who were randomized to study treatment. Here, "N" signifies number of participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | U/kg/week | Week 1 up to Week 24 |
|
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| Secondary | Total Dose of Study Medication Administered | ITT population included all participants who were randomized to study treatment. Here, "N" signifies number of participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units of study medication | Week 1 up to Week 24 |
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| Secondary | Percentage of Participants With Mean Weekly Hemoglobin Level Within the Target Range | Percentage of participants who had hemoglobin level within the target range of 9 to 11 g/dL for the specified weeks were reported. | ITT population included all participants who were randomized to study treatment. | Posted | Number | percentage of participants | Week 12, 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Required Permanent Dose Changes of Study Medication | Per protocol population was a subset of ITT participants who did not have major protocol violations. | Posted | Number | percentage of participants | Week 1 up to Week 24 |
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| Secondary | Percentage of Participants Who Required Temporary Dose Changes of Study Medication | Per protocol population was a subset of ITT participants who did not have major protocol violations. | Posted | Number | percentage of participants | Week 1 up to Week 24 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 1 Gram Per Deciliter (g/dL) | Per protocol population was a subset of ITT participants who did not have major protocol violations. | Posted | Number | percentage of participants | Week 1 up to Week 24 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Mean Weekly Hemoglobin Level Outside the Target Range | Percentage of participants who had hemoglobin level outside the target range of 9 to 11 g/dL for the specified weeks were reported. | ITT population included all participants who were randomized to study treatment. | Posted | Number | percentage of participants | Week 12, 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Received Blood Transfusions | ITT population included all participants who were randomized to study treatment. Here, "N" signifies number of participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Week 1 up to Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level | In this outcome measure number of participants with change (increase and decrease) in mean dose of Epoetin Hospira and Epogen were categorized and reported according to their mean hemoglobin levels. Hemoglobin levels were divided in following classes: >11.0 g/dL, from 9.0 to 11.0 g/dL and <9.0 g/dL | ITT population included all participants who were randomized to study treatment. Here, "N" signifies number of participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Week 1 up to Week 24 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Any Transient Change of Hemoglobin Greater Than (>) 2.0 Gram Per Deciliter (g/dL) in Hemoglobin Level | Safety population included all participants who received at least 1 dose of study treatment. | Posted | Number | percentage of participants | Week 1 up to Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL) | Safety population included all participants who received at least 1 dose of study treatment. | Posted | Number | percentage of participants | Week 1 up to Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL) | Safety population included all participants who received at least 1 dose of study treatment. | Posted | Number | percentage of participants | Week 1 up to Week 24 |
|
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| Other Pre-specified | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged in-patient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events from first dose of study drug to the end of study (up to Week 28) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events. | Safety population included all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Week 1 up to Week 28 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Treatment-Emergent Adverse Events by Severity | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug to the end of study (up to Week 28) that were absent before treatment or that worsened relative to pre-treatment state. An AE was assessed according to severity; mild (AE was transient and easily tolerated by the participant), moderate (caused problem that did not interfere significantly with usual activities) and severe (caused problem that interferes significantly with usual activities and might be incapacitating or life-threatening). | 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 | Week 1 up to Week 28 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Treatment Related Adverse Events (AEs) | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. | 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 | Week 1 up to Week 28 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants That Discontinued Treatment Due to a Treatment Emergent Adverse Event | In this outcome measure number of participants who discontinued from study drug (Epoetin Hospira, Epogen) due to any AE were reported. | 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 | Week 1 up to Week 28 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Baseline up to Week 28 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Baseline up to Week 28 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Baseline up to Week 28 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Baseline up to Week 28 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Number | percentage of participants | Week 1 up to Week 28 |
|
|
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 | Participants were enrolled to receive intravenous (IV) injection of Epoetin Hospira 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Participants were followed up to Week 28. | 75 | 301 | 143 | 301 | ||
| EG001 | Epogen | Participants were enrolled to receive IV injection of Epogen 1 to 3 times every week over a period of 24 weeks. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Participants were followed up to Week 28. | 82 | 304 | 141 | 304 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cardiac failure | 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 |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pulseless electrical activity | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Congenital cystic kidney disease | Congenital, familial and genetic disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Gastrointestinal arteriovenous malformation | Congenital, familial and genetic disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Diabetic retinopathy | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Colonic polyp | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Gastrointestinal disorder | 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 |
| |
| Ileus | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Device malfunction | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Medical device complication | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pelvic mass | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Arteriovenous graft site infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Bursitis infective | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Chest wall abscess | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cytomegalovirus colitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cytomegalovirus viraemia | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Endocarditis | 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 |
| |
| Graft infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Lobar pneumonia | 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 |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| West Nile viral infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Arteriovenous fistula site complication | 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 |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Graft thrombosis | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Postoperative fever | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Rib fracture | 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 |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Transplant failure | 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 |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Diabetic foot | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | 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 |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
| |
| Colon cancer stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
| |
| Lung cancer metastatic | 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 |
| |
| Plasmacytoma | 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 event was gender specific. |
|
| Basal ganglia haemorrhage | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cervical myelopathy | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| IIIrd nerve paralysis | 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 |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Renal cyst ruptured | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Bronchiectasis | 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 |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Non-cardiogenic pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | 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 arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Steal syndrome | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Muscle spasms | 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 |
| |
| Dizziness | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | 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 |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D007676 | Kidney Failure, 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
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