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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

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Montgomery Kidney Specialists
Montgomery, Alabama, 36106 United States
Contact
1-800-718-1021
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)

NCT01473407
Pfizer
Completed
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

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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
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Chronic Kidney Disease
  • Chronic Renal Failure
  • Biological: Epoetin Hospira
    Variable dose
  • Biological: Epogen (Amgen)
    Variable dose
    Other Name: Epoetin Alfa
  • Experimental: Epoetin Hospira
    Epoetin Hospira
    Intervention: Biological: Epoetin Hospira
  • Active Comparator: Epogen (Amgen)
    Epogen (Amgen)
    Intervention: Biological: Epogen (Amgen)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
612
674
February 14, 2014
February 14, 2014   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   United States
 
 
NCT01473407
EPOE-10-01
C3461001 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Hospira, now a wholly owned subsidiary of Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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