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

NCT01628107

Last updated date
Study Location
North America Research Institute
Azusa, California, 91702, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Renal Failure Requiring Hemodialysis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Patient is able to provide written Informed Consent after the risks and benefits of the study have been explained prior to any study-related activities.

2. Patient previously completed the core study Treatment Period up to and including Week 24 study assessments per protocol and is willing to continue open-label Epoetin Hospira for up to 48 weeks.

3. If female, patient must be postmenopausal for at least 1 year prior to enrollment, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or practicing at least 1 of the following methods of birth control:

- Hormonal contraceptives (oral, parenteral, or transdermal) for at least 3 months prior to enrollment

- Intrauterine device

- Double-barrier method (condoms, contraceptive sponge, diaphragm, or vaginal ring with spermicidal jellies or cream)

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

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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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Chronic Renal Failure Requiring HemodialysisA Phase 3, Long-Term Safety Study of Intravenous Epoetin Hospira in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin NCT01628107
  1. Azusa, California
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  70. New York, New York
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  74. North Brunswick, New Jersey
  75. Sewell, New Jersey
  76. Voorhees, New Jersey
  77. Voorhees, New Jersey
  78. College Point, New York
  79. Flushing, New York
  80. Fresh Meadows, New York
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  82. Raleigh, North Carolina
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  85. Cincinnati, Ohio
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Advanced Information
Descriptive Information
Brief Title  ICMJE A Phase 3, Long-Term Safety Study of Intravenous Epoetin Hospira in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin
Official Title  ICMJE A Phase III, Open-label, Multicenter, Long-term Safety Study Of Intravenous Epoetin Hospira In Patients With Chronic Renal Failure Requiring Hemodialysis And Receiving Epoetin Maintenance Treatment
Brief Summary The purpose of the study is to determine the long-term safety in treatment-emergent adverse events (TEAEs) of intravenous (IV) administration of Epoetin Hospira for maintenance of target hemoglobin (Hgb) levels in patients treated for anemia associated with chronic renal failure and on hemodialysis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Renal Failure Requiring Hemodialysis
Intervention  ICMJE Biological: Epoetin Hospira
Intravenous (IV) injection
Other Names:
  • ESA
  • Erythropoetin Stimulating Agent
Study Arms  ICMJE Experimental: Epoetin Hospira
Epoetin Hospira will be administered by IV 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.
Intervention: Biological: Epoetin Hospira
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 22, 2018)
406
Original Estimated Enrollment  ICMJE
 (submitted: June 22, 2012)
674
Actual Study Completion Date  ICMJE January 2, 2015
Actual Primary Completion Date January 2, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patient is able to provide written Informed Consent after the risks and benefits of the study have been explained prior to any study-related activities.
  2. Patient previously completed the core study Treatment Period up to and including Week 24 study assessments per protocol and is willing to continue open-label Epoetin Hospira for up to 48 weeks.
  3. If female, patient must be postmenopausal for at least 1 year prior to enrollment, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or practicing at least 1 of the following methods of birth control:

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

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

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

Exclusion Criteria:

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

    • Myocardial infarction
    • Stroke (cerebrovascular accident)/cerebrovascular insult (minor stroke) or transient ischemic attack/intracerebral bleeding/cerebral infarction
    • Severe/unstable angina
    • Coronary angioplasty, bypass surgery, or peripheral artery bypass graft
    • Decompensated congestive heart failure (New York Heart Association [NYHA] class IV)
    • Pulmonary embolism
    • Deep vein thrombosis or other thromboembolic event
    • Received live or attenuated vaccination (except flu vaccination)
  3. A patient with any active, uncontrolled systemic, inflammatory, or malignant disease that developed during the core study and in the Investigator's opinion may be significant to exclude participation in the study, including but not limited to demyelinating diseases such as multiple sclerosis, microbial, viral, or fungal infection or mental disease.
  4. Any newly developed significant drug sensitivity or a significant allergic reaction to any drug, as well as known hypersensitivity or idiosyncratic reaction to epoetin (or its excipients, including albumin) or any other related drugs that in the judgment of the Investigator is exclusionary for study participation.
  5. A female patient who is pregnant, lactating, or planning a pregnancy during the study.
  6. History of drug abuse or alcohol abuse during the core study prior to enrollment as determined by the Investigator.
  7. Current participation or participation in a drug or other investigational research study within 30 days prior to enrollment (except the core study or any observational studies with prior written approval from Hospira).
  8. May not be able to comply with the requirements of this clinical study, communicate effectively with study personnel, or is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
  9. Evidence of human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg).
  10. A patient who, in the Investigator's opinion, has any clinically significant abnormal laboratory results that may impact patient safety.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01628107
Other Study ID Numbers  ICMJE EPOE-11-03
C3461004 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP