A Phase 3 Study Comparing the Effects of Intravenous Epoetin Hospira and Epoetin Alfa (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin (AiME - 01)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT01473407
First received: November 2, 2011
Last updated: May 1, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
Chronic Renal Failure
Biological: Epoetin Hospira
Biological: Epogen (Amgen)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hospira, Inc.:

Primary Outcome Measures:
  • Difference between treatments (Epoetin Hospira and Epogen [Amgen]) in mean weekly Hb level during the last 4 weeks of the double-blind Treatment Period (i.e., Week 21 to Week 24) [ Time Frame: Baseline and last 4 weeks of Treatement Period ] [ Designated as safety issue: No ]
  • Difference between treatments (Epoetin Hospira and Epogen [Amgen]) in mean weekly dosage per kg body weight during the last 4 weeks of the double-blind Treatment Period (i.e., Week 21 to Week 24) [ Time Frame: Baseline and last 4 weeks of Treatement Period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference between treatments (Epoetin Hospira and Epogen [Amgen]) in mean weekly Hb level in 24 weeks of treatment [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Difference between treatments (Epoetin Hospira and Epogen [Amgen]) in mean weekly dosage per kg body weight delivered in 24 weeks of treatment [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
  • The total dose delivered during the 24 weeks of treatment in the Treatment Period [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
  • The proportion of patients with a weekly mean Hb level within the target range (9-11 g/dL) at Week 12 and Week 24 of the Treatment Period [ Time Frame: Week 12 and Week 24 ] [ Designated as safety issue: No ]
  • The proportion of patients requiring permanent dose changes during the Treatment Period [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
  • The proportion of patients requiring temporary dose changes during the Treatment Period [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
  • The proportion of patients with any transient change of Hb level >1 g/dL during the Treatment Period [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
  • The proportion of patients with any Hb measurement outside the target range during the Treatment Period [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Incidence of patients receiving blood transfusions for each treatment group [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 612
Study Start Date: November 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Epoetin Hospira
Epoetin Hospira
Biological: Epoetin Hospira
Variable dose
Active Comparator: Epogen (Amgen)
Epogen (Amgen)
Biological: Epogen (Amgen)
Variable dose

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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:

  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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01473407

  Show 68 Study Locations
Sponsors and Collaborators
Hospira, Inc.
  More Information

No publications provided

Responsible Party: Hospira, Inc.
ClinicalTrials.gov Identifier: NCT01473407     History of Changes
Other Study ID Numbers: EPOE-10-01
Study First Received: November 2, 2011
Last Updated: May 1, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 03, 2015