A Phase 3 Study Comparing the Effects of Intravenous Epoetin Hospira and Epoetin Alfa [Epogen] (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin

NCT01473407

Last updated date
Study Location
Montgomery Kidney Specialists
Montgomery, Alabama, 36106, 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 Kidney Disease, Chronic Renal Failure
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 risks and benefits of the study have been explained prior to any study related activities

2. 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:

- Mean hemoglobin during the 4 weeks prior to randomization between 9.0 and 11.0 g/dL

- No more than one hemoglobin outside of range from 9.0-11.0 g/dL during the 4 weeks prior to randomization

- No hemoglobin result more than ±1 g/dL from the mean hemoglobin level during the 4 week period prior to randomization

3. 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

4. Patients with adequate iron stores, defined as ferritin >100 μg/L and TSAT >20%, prior to randomization

5. Male or female patients aged 18 to 80 years (both inclusive)

6. 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:

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

- intrauterine device (IUD)

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


1. Maintenance Epoetin dosage >600 U/kg per week (1-3 times per week)


2. Treatment with long-acting epoetin analogues such as Aranesp ® within 3 months prior
to randomization


3. Any of the following within 3 months prior to randomization:


- 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)


4. 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


5. Known, clinically manifested deficiency of folic acid and/or vitamin B12 (irrespective
of whether currently treated or not)


6. 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


7. Contraindication for the test drug or have been previously treated with Epoetin
Hospira


8. Relative or absolute iron deficiency prior to randomization


9. Platelet count below 100 x 10^9/L


10. Clinically relevant increase of CRP (>10 mg/dL) for at least 2 weeks


11. 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


12. History of any of the following:


- Detectable anti- rhEPO antibodies


- Clinically relevant malnutrition


- Confirmed aluminum intoxication


- Myelodysplastic syndrome


- Known bone marrow fibrosis (osteitis fibrosa cystica)


- Known seizure disorder


- Liver cirrhosis with clinical evidence of complications (portal hypertension,
splenomegaly, ascites)


13. A female patient who is pregnant, lactating or planning a pregnancy during the study


14. History of drug abuse or alcohol abuse within 2 years prior to randomization as
determined by the Investigator


15. Current participation or participation in a drug or other investigational research
study within 30 days prior to randomization


16. 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


17. 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


18. A patient who in the Investigator's opinion, has any clinically significant abnormal
laboratory evaluations, including liver function taken at Screening Visit


19. Positive laboratory test for human immunodeficiency virus (HIV) or hepatitis B surface
antigen (HBsAg)

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Chronic Kidney Disease, Chronic Renal FailureA Phase 3 Study Comparing the Effects of Intravenous Epoetin Hospira and Epoetin Alfa [Epogen] (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin NCT01473407
  1. Montgomery, Alabama
  2. Tempe, Arizona
  3. Alhambra, California
  4. Azusa, California
  5. Bakersfield, California
  6. Fairfield, California
  7. Glendale, California
  8. Granada Hills, California
  9. La Puente, California
  10. Lakewood, California
  11. Long Beach, California
  12. Long Beach, California
  13. Los Angeles, California
  14. Modesto, California
  15. National City, California
  16. Northridge, California
  17. Ontario, California
  18. Porterville, California
  19. Tarzana, California
  20. West Covina, California
  21. Whittier, California
  22. Whittier, California
  23. Yuba City, California
  24. Middlebury, Connecticut
  25. Coral Springs, Florida
  26. Lauderdale Lakes, Florida
  27. Miami, Florida
  28. Miami, Florida
  29. Naples, Florida
  30. Naples, Florida
  31. North Miami Beah, Florida
  32. Ocala, Florida
  33. Orlando, Florida
  34. Dublin, Georgia
  35. Meridian, Idaho
  36. Evergreen Park, Illinois
  37. Gurnee, Illinois
  38. Merrillville, Indiana
  39. Marrero, Louisiana
  40. New Orleans, Louisiana
  41. Shreveport, Louisiana
  42. Clinton Township, Michigan
  43. Detroit, Michigan
  44. Gulfport, Mississippi
  45. Saint Louis, Missouri
  46. Las Vegas, Nevada
  47. Eatontown, New Jersey
  48. Brooklyn, New York
  49. New York, New York
  50. Asheville, North Carolina
  51. Greenville, North Carolina
  52. New Bern, North Carolina
  53. Winston-Salem, North Carolina
  54. Cincinnati, Ohio
  55. Columbus, Ohio
  56. Erie, Pennsylvania
  57. Erie, Pennsylvania
  58. Erie, Pennsylvania
  59. Philadelphia, Pennsylvania
  60. Philadelphia, Pennsylvania
  61. Anderson, South Carolina
  62. Columbia, South Carolina
  63. Columbia, South Carolina
  64. Orangeburg, South Carolina
  65. Orangeburg, South Carolina
  66. Sumter, South Carolina
  67. Chattanooga, Tennessee
  68. Arlington, Texas
  69. Greenville, Texas
  70. Houston, Texas
  71. Houston, Texas
  72. Houston, Texas
  73. Houston, Texas
  74. Houston, Texas
  75. Houston, Texas
  76. Houston, Texas
  77. Lubbock, Texas
  78. McAllen, Texas
  79. Missouri City, Texas
  80. San Antonio, Texas
  81. San Antonio, Texas
  82. Fairfax, Virginia
  83. Hampton, Virginia
  84. Norfolk, Virginia
  85. Caguas,
ALL GENDERS
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MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Phase 3 Study Comparing the Effects of Intravenous Epoetin Hospira and Epoetin Alfa [Epogen] (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin
Official Title  ICMJE A Therapeutic-equivalence Study Comparing The Efficacy And Safety Of Intravenous Epoetin Hospira And Epoetin Alfa (Amgen) In Patients With Chronic Renal Failure Requiring Hemodialysis And Receiving Epoetin Maintenance Treatment
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Kidney Disease
  • Chronic Renal Failure
Intervention  ICMJE
  • Biological: Epoetin Hospira
    Variable dose
  • Biological: Epogen (Amgen)
    Variable dose
    Other Name: Epoetin Alfa
Study Arms  ICMJE
  • Experimental: Epoetin Hospira
    Epoetin Hospira
    Intervention: Biological: Epoetin Hospira
  • Active Comparator: Epogen (Amgen)
    Epogen (Amgen)
    Intervention: Biological: Epogen (Amgen)
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: April 9, 2014)
612
Original Estimated Enrollment  ICMJE
 (submitted: November 16, 2011)
674
Actual Study Completion Date  ICMJE February 11, 2014
Actual Primary Completion Date February 11, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patient is able to provide written informed consent after risks and benefits of the study have been explained prior to any study related activities
  2. 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:

      • Mean hemoglobin during the 4 weeks prior to randomization between 9.0 and 11.0 g/dL
      • No more than one hemoglobin outside of range from 9.0-11.0 g/dL during the 4 weeks prior to randomization
      • No hemoglobin result more than ±1 g/dL from the mean hemoglobin level during the 4 week period prior to randomization
  3. 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
  4. Patients with adequate iron stores, defined as ferritin >100 ?g/L and TSAT >20%, prior to randomization
  5. Male or female patients aged 18 to 80 years (both inclusive)
  6. 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:

    • hormonal contraceptives (oral, parenteral, or transdermal) for at least 3 months prior to randomization
    • intrauterine device (IUD)
    • 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 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:

  1. Maintenance Epoetin dosage >600 U/kg per week (1-3 times per week)
  2. Treatment with long-acting epoetin analogues such as Aranesp ® within 3 months prior to randomization
  3. Any of the following within 3 months prior to randomization:

    • 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)
  4. 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
  5. Known, clinically manifested deficiency of folic acid and/or vitamin B12 (irrespective of whether currently treated or not)
  6. 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
  7. Contraindication for the test drug or have been previously treated with Epoetin Hospira
  8. Relative or absolute iron deficiency prior to randomization
  9. Platelet count below 100 x 10^9/L
  10. Clinically relevant increase of CRP (>10 mg/dL) for at least 2 weeks
  11. 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
  12. History of any of the following:

    • Detectable anti- rhEPO antibodies
    • Clinically relevant malnutrition
    • Confirmed aluminum intoxication
    • Myelodysplastic syndrome
    • Known bone marrow fibrosis (osteitis fibrosa cystica)
    • Known seizure disorder
    • Liver cirrhosis with clinical evidence of complications (portal hypertension, splenomegaly, ascites)
  13. A female patient who is pregnant, lactating or planning a pregnancy during the study
  14. History of drug abuse or alcohol abuse within 2 years prior to randomization as determined by the Investigator
  15. Current participation or participation in a drug or other investigational research study within 30 days prior to randomization
  16. 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
  17. 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
  18. A patient who in the Investigator's opinion, has any clinically significant abnormal laboratory evaluations, including liver function taken at Screening Visit
  19. Positive laboratory test for human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg)
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 NCT01473407
Other Study ID Numbers  ICMJE EPOE-10-01
C3461001 ( 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 Hospira, now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2018

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