A Phase 3 Study Comparing the Effects of Subcutaneous 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

NCT01473420

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Renal Failure, Chronic Kidney Disease
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) dose administered IV or SC, 1 to 3 times per week for whom the following apply:

- A change in Epogen dosing of no more than 10% from the mean

- Mean hemoglobin between 9.0 and 11.0 g/dL

- No more than one hemoglobin result outside of range from 9.0-11.0 g/dL

- No hemoglobin result more than ±1 g/dL from the mean hemoglobin level

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 plasma 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 postmenopausal for at least one year prior to randomization, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least one of the following methods of birth control:

- 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 12 weeks 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
that in the Investigator's opinion may be significant to exclude participation in the
study, including but not limited to demyelinating diseases such as multiple sclerosis,
microbial, viral or fungal infection or mental disease


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


8. Relative or absolute iron deficiency prior to randomization into the Maintenance
Period


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)

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Chronic Renal Failure, Chronic Kidney DiseaseA Phase 3 Study Comparing the Effects of Subcutaneous 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 NCT01473420
  1. Azusa, California
  2. Bakersfield, California
  3. Long Beach, California
  4. Los Angeles, California
  5. Modesto, California
  6. Northridge, California
  7. Northridge, California
  8. Paramount, California
  9. Pleasanton, California
  10. Rancho Cordova, California
  11. Sacramento, California
  12. San Leandro, California
  13. San Leandro, California
  14. Santa Clarita, California
  15. Whittier, California
  16. Whittier, California
  17. Whittier, California
  18. Arvada, Colorado
  19. Westminster, Colorado
  20. Westminster, Colorado
  21. Pembroke Pines, Florida
  22. Albany, Georgia
  23. Augusta, Georgia
  24. Dublin, Georgia
  25. Chicago, Illinois
  26. Evergreen Park, Illinois
  27. Wichita, Kansas
  28. Lafayette, Louisiana
  29. Lafayette, Louisiana
  30. Marrero, Louisiana
  31. Opelousas, Louisiana
  32. Shreveport, Louisiana
  33. Kalamazoo, Michigan
  34. Kalamazoo, Michigan
  35. Kalamazoo, Michigan
  36. Kalamazoo, Michigan
  37. Kalamazoo, Michigan
  38. Kansas City, Missouri
  39. Kansas City, Missouri
  40. Kansas City, Missouri
  41. Saint Louis, Missouri
  42. North Brunswick, New Jersey
  43. Voorhees, New Jersey
  44. Astoria, New York
  45. Flushing, New York
  46. New Hyde Park, New York
  47. New York, New York
  48. Raleigh, North Carolina
  49. Cincinnati, Ohio
  50. Toledo, Ohio
  51. Meadville, Pennsylvania
  52. Aiken, South Carolina
  53. Columbia, South Carolina
  54. Columbia, South Carolina
  55. Irmo, South Carolina
  56. Orangeburg, South Carolina
  57. Knoxville, Tennessee
  58. Austin, Texas
  59. Austin, Texas
  60. Austin, Texas
  61. Dallas, Texas
  62. Grand Prairie, Texas
  63. Houston, Texas
  64. Houston, Texas
  65. Houston, Texas
  66. Houston, Texas
  67. Lufkin, Texas
  68. San Antonio, Texas
  69. Arlington, Virginia
  70. Fairfax, Virginia
  71. Fairfax, Virginia
  72. Mechanicsville, Virginia
  73. Olympia, Washington
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Phase 3 Study Comparing the Effects of Subcutaneous 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 Subcutaneous 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 subcutaneous (SC) Epoetin Hospira compared to SC Epogen (Amgen), based on maintenance of hemoglobin (Hb) levels and study drug dose requirements in patients treated for anemia associated with chronic renal failure and on hemodialysis.
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 Renal Failure
  • Chronic Kidney Disease
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)
320
Original Estimated Enrollment  ICMJE
 (submitted: November 16, 2011)
288
Actual Study Completion Date  ICMJE February 28, 2014
Actual Primary Completion Date February 28, 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) dose administered IV or SC, 1 to 3 times per week for whom the following apply:

    • A change in Epogen dosing of no more than 10% from the mean
    • Mean hemoglobin between 9.0 and 11.0 g/dL
    • No more than one hemoglobin result outside of range from 9.0-11.0 g/dL
    • No hemoglobin result more than ±1 g/dL from the mean hemoglobin level
  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 plasma 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 postmenopausal for at least one year prior to randomization, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least one of the following methods of birth control:

    • 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 12 weeks 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 that in the Investigator's opinion may be significant to exclude participation in the study, including but not limited to demyelinating diseases such as multiple sclerosis, microbial, viral or fungal infection or mental disease
  7. Contraindication for the test drug or have been previously treated with Epoetin Hospira
  8. Relative or absolute iron deficiency prior to randomization into the Maintenance Period
  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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01473420
Other Study ID Numbers  ICMJE EPOE-10-13
C3461003 ( 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 July 2018

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