A Phase 3, Long-Term Safety Study of Subcutaneous Epoetin Hospira in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME -Anemia Management With Epoetin (AiME - 04)

February 27, 2019 updated by: Pfizer

A Phase 3, Open-label, Multicenter, Long-term Safety Study Of Subcutaneous Epoetin Hospira In Patients With Chronic Renal Failure Requiring Hemodialysis And Receiving Epoetin Maintenance Treatment

To determine the long term safety in treatment-emergent adverse events (TEAEs) of SC administration of Epoetin Hospira for maintenance of target hemoglobin (Hgb) levels in patients treated for anemia associated with chronic renal failure and on hemodialysis.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

170

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Azusa, California, United States, 91702
      • Azusa, California, United States, 91702
        • Azusa Dialysis Center
      • Bakersfield, California, United States, 93309
      • Bakersfield, California, United States, 93309
        • National Institute of Clinical Research
      • Bakersfield, California, United States, 93308
        • Pegasus Dialysis
      • Bellflower, California, United States, 90706
        • Bellflower Dialysis Center
      • Granada Hills, California, United States, 91344
      • Lakewood, California, United States, 90712
        • Lakewood Dialysis Center
      • Long Beach, California, United States, 90813
      • Long Beach, California, United States, 90806
        • Westcoast Dialysis
      • Long Beach, California, United States, 90813
        • Long Beach Dialysis
      • Long Beach, California, United States, 90813
        • Novo Research
      • Los Angeles, California, United States, 90022
        • Academic Medical Research Institute
      • Los Angeles, California, United States, 90022
      • Los Angeles, California, United States, 90022
        • East LA Dialysis Center
      • Modesto, California, United States, 95350
      • Modesto, California, United States, 95350
        • Modesto Kidney Center
      • Modesto, California, United States, 95350
        • Novo Research, Inc. d/b/a Foundation Research
      • Modesto, California, United States, 95350
        • Parkway Kidney Center
      • Northridge, California, United States, 91324
      • Northridge, California, United States, 91324
        • US Renal Care of Northridge
      • Norwalk, California, United States, 90650
        • Norwalk Dialysis Center
      • Oakdale, California, United States, 95361
        • Oakdale Kidney Center
      • Panorama City, California, United States, 91402
        • US Renal Care of Panorama City
      • Paramount, California, United States, 90723
      • Paramount, California, United States, 90723
        • Mohammad Ismail MD, Inc.
      • Paramount, California, United States, 90723
        • Paramount Dialysis Center
      • Santa Clarita, California, United States, 91387
        • Canyon Country Dialysis Center
      • Simi Valley, California, United States, 93065
        • California Kidney Medical Group
      • Van Nuys, California, United States, 91405
        • US Renal Care of Van Nuys
      • Whittier, California, United States, 90603
      • Whittier, California, United States, 90603
        • American Institute of Research
      • Whittier, California, United States, 90602
        • intercommunity Dialysis Center
      • Whittier, California, United States, 90603
        • Whittier Kidney Dialysis Center
    • Colorado
      • Arvada, Colorado, United States, 80002
        • Western Nephrology and Metabolic Bone Disease, PC
      • Arvada, Colorado, United States, 80002
        • Kidney Center of Arvada
      • Arvada, Colorado, United States, 80002
      • Westminster, Colorado, United States, 80031
        • Kidney Center of westminster, LLC
      • Westminster, Colorado, United States, 80031
        • Western Nephrology and Metabolic Bone Disease, PC
      • Westminster, Colorado, United States, 80031
    • Florida
      • Pembroke Pines, Florida, United States, 33028
        • Pines Clinical Research, Inc.
      • Pembroke Pines, Florida, United States, 33028
    • Georgia
      • Augusta, Georgia, United States, 30901
      • Augusta, Georgia, United States, 30901
        • Nephrology Centers of America - Augusta (NCA-A)
      • Augusta, Georgia, United States, 30906
        • Nephrology Centers of America (NCA) South Augusta
      • Augusta, Georgia, United States, 30909
        • Kidney Care Associates, LLC
      • Grovetown, Georgia, United States, 30813
        • Grovetown Dialysis Center
      • Macon, Georgia, United States, 31217
        • East Macon Dialysis
      • Macon, Georgia, United States, 31217
        • Renal Physicians of Georgia, PC
      • Macon, Georgia, United States, 31217
      • Perry, Georgia, United States, 31069
        • Perry Dialysis Center
      • Waynesboro, Georgia, United States, 30830
        • Waynesboro Dialysis Center
    • Kansas
      • Wichita, Kansas, United States, 67214
      • Wichita, Kansas, United States, 67214
        • Fresenius Medical Care Midtown #8498
      • Wichita, Kansas, United States, 67214
        • Kansas Nephrology Research Institute, LLC
    • Louisiana
      • Lafayette, Louisiana, United States, 70506
      • Lafayette, Louisiana, United States, 70501
        • FMC Northside
      • Lafayette, Louisiana, United States, 70503
        • Research Nurse Specialists ,LLC
      • Opelousas, Louisiana, United States, 70570
        • FMC Opelousas
    • Michigan
      • Kalamazoo, Michigan, United States, 49007
      • Kalamazoo, Michigan, United States, 49007
        • Nephrology Center DBA Paragon Health PC
      • Kalamazoo, Michigan, United States, 49001
        • Fresenius Medical Care- Kalamazoo East
      • Kalamazoo, Michigan, United States, 49007
        • Fresenius Medical Care - Kalamazoo
      • Kalamazoo, Michigan, United States, 49009
        • Fresenius Medical Care - Oshtermo
      • Kalamazoo, Michigan, United States, 49048
        • Fresenius Medical Care- Gull Road
    • Missouri
      • Belton, Missouri, United States, 64012
      • Belton, Missouri, United States, 66012
        • Dialysis Clinics, Inc. - Belton
      • Florissant, Missouri, United States, 63033
        • FMC Metro North Dialysis
      • Normandy, Missouri, United States, 63121
        • FMC Normandy Dialysis
      • Saint Ann, Missouri, United States, 63074
        • FMC St. Louis Regional Dialysis
      • Saint Louis, Missouri, United States, 63136
      • Saint Louis, Missouri, United States, 63136
        • Metro Hypertension and Kidney Center
    • New Jersey
      • North Brunswick, New Jersey, United States, 08902
        • Dialysis Clinic Incorporated
      • North Brunswick, New Jersey, United States, 08902
      • Sewell, New Jersey, United States, 08080
        • Kennedy Dialysis Center
      • Voorhees, New Jersey, United States, 08043
      • Voorhees, New Jersey, United States, 08043
        • Kennedy Dialysis Center
    • New York
      • College Point, New York, United States, 11356
      • Flushing, New York, United States, 11355
      • Fresh Meadows, New York, United States, 11365
        • Trude Weishaupt Memorial Dialysis Center
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
      • Raleigh, North Carolina, United States, 27609
        • Wake Nephrology Associates, PA
      • Raleigh, North Carolina, United States, 27609
        • Wake Dialysis Clinic
    • Ohio
      • Cincinnati, Ohio, United States, 45267
      • Cincinnati, Ohio, United States, 45206
        • DCI McMillan
      • Toledo, Ohio, United States, 43606
      • Toledo, Ohio, United States, 43606
        • Innovative Dialysis of Toledo
      • Toledo, Ohio, United States, 43606
        • Toledo Hospital, Promedica Health System
      • Toledo, Ohio, United States, 43613
        • Alexis Dialysis Center
      • Toledo, Ohio, United States, 43615
        • Wildwood Dialysis Center
    • Pennsylvania
      • Meadville, Pennsylvania, United States, 16335
        • meadville Dialysis
      • Meadville, Pennsylvania, United States, 16335
        • The Center for Hypertension and Nephrology Care
    • Tennessee
      • Knoxville, Tennessee, United States, 37923
        • Knoxville Kidney Center, PLLC
      • Knoxville, Tennessee, United States, 37921
        • Fresenius Medical Care
      • Knoxville, Tennessee, United States, 37923
        • Cedar Bluff Dialysis
      • Knoxville, Tennessee, United States, 37923
    • Texas
      • Austin, Texas, United States, 78758
      • Austin, Texas, United States, 78758
        • Research Management, Inc.
      • Austin, Texas, United States, 78758
        • Fresenius Medical Care-Austin North Dialysis
      • Austin, Texas, United States, 78758
        • Research Management Inc.
      • Cedar Park, Texas, United States, 78613
        • Fresenius Medical Care - Cedar Park
      • Grand Prairie, Texas, United States, 75051
        • Grand Prairie Dialysis Center
      • Grand Prairie, Texas, United States, 75051
      • Houston, Texas, United States, 77099
      • Houston, Texas, United States, 77083
        • Mission Bend Dialysis
      • Houston, Texas, United States, 77099
        • Southwest Houston Research, Ltd.
      • Lufkin, Texas, United States, 75904
        • SNG Dialysis Center of Lufkin
      • Lufkin, Texas, United States, 75904
      • San Antonio, Texas, United States, 78237
      • San Antonio, Texas, United States, 78229
        • San Antonio Kidney Disease Center Physicians Group, P.L.L.C.
      • San Antonio, Texas, United States, 78237
        • Las Palmas Davita Dialysis Center
    • Virginia
      • Mechanicsville, Virginia, United States, 23116
        • ARA Mechanicsville Dialysis
      • Mechanicsville, Virginia, United States, 23116
        • Nephrology Specialists, P.C.
      • Mechanicsville, Virginia, United States, 23116
      • Richmond, Virginia, United States, 23231
        • ARA South Laburnum Dialysis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient is able to provide written Informed Consent after the risks and benefits of the study have been explained prior to any study related activities.
  2. Patient previously completed the core study Maintenance Period up to and including Week 16 study assessments per protocol and is willing to continue open-label Epoetin Hospira for up to 48 weeks.
  3. If female, patient must be postmenopausal for at least 1 year prior to enrollment, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or practicing at least 1 of the following methods of birth control:

    • hormonal contraceptives (oral, parenteral, or transdermal) for at least 3 months prior to enrollment
    • intrauterine device
    • double-barrier method (condoms, contraceptive sponge, diaphragm, or vaginal ring with spermicidal jellies or cream)

    If hormonal contraceptives are used, the specific contraceptive must have been used for at least 3 months prior to enrollment. If the patient is currently using a hormonal contraceptive, she should also use a barrier method during this study and for at least 30 days following the administration of the patient's last open-label dose.

  4. Adequate methods of contraception to prevent pregnancy are to be maintained throughout the course of the study in both male and female study subjects.

Exclusion Criteria:

  1. Patient had a serious or severe adverse event in the core study that, in the opinion of the Investigator, was probably or definitely related to epoetin use and precluded safe use of epoetin.
  2. Any of the following that developed during the core study and prior to enrollment:

    • Myocardial infarction
    • Stroke (cerebrovascular accident)/cerebrovascular insult (minor stroke) or transient ischemic attack/intracerebral bleeding/cerebral infarction
    • Severe/unstable angina
    • Coronary angioplasty, bypass surgery, or peripheral artery bypass graft
    • Decompensated congestive heart failure (New York Heart Association [NYHA] class IV)
    • Pulmonary embolism
    • Deep vein thrombosis or other thromboembolic event
    • Received live or attenuated vaccination (except flu vaccination)
  3. A patient with any active, uncontrolled systemic, inflammatory, or malignant disease that developed during the core study and in the Investigator's opinion may be significant to exclude participation in the study, including but not limited to demyelinating diseases such as multiple sclerosis, microbial, viral, or fungal infection or mental disease.
  4. Any newly developed significant drug sensitivity or a significant allergic reaction to any drug, as well as known hypersensitivity or idiosyncratic reaction to epoetin (or its excipients, including albumin) or any other related drugs that in the judgment of the Investigator is exclusionary for study participation.
  5. A female patient who is pregnant, lactating, or planning a pregnancy during the study.
  6. History of drug abuse or alcohol abuse during the core study prior to enrollment as determined by the Investigator.
  7. Current participation or participation in a drug or other investigational research study within 30 days prior to enrollment (except the core study or any observational studies with prior written approval from Hospira).
  8. May not be able to comply with the requirements of this clinical study, communicate effectively with study personnel, or is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
  9. Evidence of human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg).
  10. A patient who, in the Investigator's opinion, has any clinically significant abnormal laboratory results that may impact patient safety.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Epoetin Hospira
Epoetin Hospira will be administered by SC bolus injection 1 to 3 times per week per each patient's dosing schedule. Other ESAs (except for long-acting) may be used as rescue therapy.
Subcutaneous(SC) injection
Other Names:
  • ESA
  • Erythropoetin Stimulation Agents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Week 1
Time Frame: Up through 7 days after first dose of study drug (Week 1)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
Up through 7 days after first dose of study drug (Week 1)
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 12
Time Frame: Week 1 up to Week 12
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
Week 1 up to Week 12
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 13 to 24
Time Frame: Week 13 up to Week 24
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
Week 13 up to Week 24
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 25 to 36
Time Frame: Week 25 up to Week 36
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
Week 25 up to Week 36
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 37 to 48
Time Frame: Week 37 up to Week 48
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
Week 37 up to Week 48
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 48
Time Frame: Week 1 up to Week 48
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
Week 1 up to Week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Weekly Dosage of Epoetin Hospira: Over Week 1 to 48
Time Frame: Week 1 up to Week 48
Week 1 up to Week 48
Mean Weekly Dosage of Epoetin Hospira for Interval of 12 Weeks
Time Frame: Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48
Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48
Mean Hemoglobin Levels: Over Week 1 to 48
Time Frame: Week 1 up to Week 48
Week 1 up to Week 48
Mean Hemoglobin Levels for Interval of 12 Weeks
Time Frame: Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48
Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48
Mean Hematocrit Levels: Over Week 1 to 48
Time Frame: Week 1 up to Week 48
Hematocrit is defined as the percentage of red blood cells in the blood.
Week 1 up to Week 48
Mean Hematocrit Levels for Interval of 12 Weeks
Time Frame: Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48
Hematocrit is defined as the percentage of red blood cells in the blood.
Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48
Percentage of Participants With Hemoglobin Level Outside Target Range
Time Frame: Week 1 up to Week 48
Percentage of participants with hemoglobin level outside the target range of 9.0 to 11.0 g/dL were reported.
Week 1 up to Week 48
Percentage of Participants Who Received Blood Transfusions
Time Frame: Week 1 up to Week 48
Week 1 up to Week 48

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL)
Time Frame: Week 1 up to Week 48
Week 1 up to Week 48
Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL)
Time Frame: Week 1 up to Week 48
Week 1 up to Week 48
Number of Participants With Clinically Significant Change From Baseline in Hemoglobin (Hb) Levels
Time Frame: Baseline up to Week 48
Participants with clinically significant change from baseline in hemoglobin levels were upon investigator's discretion.
Baseline up to Week 48
Number of Participants Who Received Concomitant Medication
Time Frame: Week 1 up to Week 48
Week 1 up to Week 48
Number of Participants With Clinically Significant Change From Baseline in Laboratory Tests
Time Frame: Baseline up to Week 48
Laboratory tests included: Hematology (hematocrit, hemoglobin, red blood cells count, reticulocytes, white blood cells count, neutrophils, bands, lymphocytes, monocytes, basophils, eosinophils, platelets, mean corpuscular volume); Coagulation panel (prothrombin time, international normalized ratio, activated partial thromboplastin time); Chemistry (blood urine nitrogen, creatinine, total bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, calcium, gamma-glutyl transpeptidase, phosphorus, uric acid, total protein, glucose, albumin, C-reactive protein); iron status (plasma ferritin, transferrin saturation). Participants with clinically significant change from baseline in laboratory tests were based on investigator's discretion.
Baseline up to Week 48
Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiogram (ECG)
Time Frame: Baseline up to Week 48
ECG parameters included: PR interval, QRS complex, QT interval and QTC interval. Participants with clinically significant change from baseline in 12-lead ECGs were based on investigator's discretion.
Baseline up to Week 48
Number of Participants With Clinically Significant Change From Baseline in Physical Examinations
Time Frame: Baseline up to Week 48
Physical examination included examination of the skin, eyes, ears, throat, neck, and cardiac, respiratory, gastrointestinal and musculoskeletal systems. The examination assessed the participants for any clinically significant changes in physical status, as determined by the investigator.
Baseline up to Week 48
Percentage of Participants With Anti-Recombinant Human Erythropoietin (rhEPO) Antibodies
Time Frame: Baseline, Week 48
Percentage of participants with at least 1 positive anti-rhEPO antibodies were reported. Radioimmunoprecipitation assay method was used to determine the presence of anti-rhEPO antibodies.
Baseline, Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2012

Primary Completion (Actual)

February 13, 2015

Study Completion (Actual)

February 13, 2015

Study Registration Dates

First Submitted

June 22, 2012

First Submitted That Met QC Criteria

June 22, 2012

First Posted (Estimate)

June 26, 2012

Study Record Updates

Last Update Posted (Actual)

March 18, 2019

Last Update Submitted That Met QC Criteria

February 27, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • EPOE-11-04
  • C3461005 (Other Identifier: Alias Study Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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