A Phase 3 Study Comparing the Effects of Subcutaneous 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 - 13)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT01473420
First received: November 2, 2011
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Chronic Renal Failure
Chronic Kidney Disease
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 Subcutaneous 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 in mean weekly Hb level during the last 4 weeks of the double-blind Maintenance Period [ Time Frame: Baseline and last 4 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference between treatments in mean weekly Hb levels in 16 weeks of treatment in the Maintenance Period [ Time Frame: Baseline and week 16 of the Maintenance Period ] [ Designated as safety issue: No ]
  • Difference between treatments in mean weekly dosage per kg body weigh delivered in 16 weeks of treatment in the Maintenance Period [ Time Frame: Baseline and week 16 of the Maintenance Period ] [ Designated as safety issue: No ]

Enrollment: 320
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 optimal stable Epogen (Amgen) treatment for at least 4 weeks prior to randomization where during this period Epogen (Amgen) has been administered IV or SC, 1-3 times per week with:

    • 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 teh mean hemoglobin level
  3. Patients on stable, adequate dialysis for at least 12 weeks prior to randomization
  4. Patients with adequate iron stores, defined as plasma ferritin >100 mcg/L and TSAT >20%, prior to randomization
  5. Male or female patients aged 18 to 80 years (both inclusive)
  6. If female, subject must be postmenopausal for at least one year prior to randomization, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing birth control:

Exclusion Criteria:

  1. Maintenance epoetin dosage >600 IU/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. Decompensated congestive heart failure (New York Heart Association [NYHA] class IV) within 3 months prior to randomization
  4. Cerebrovascular accident within 3 months prior to randomization
  5. Myocardial infarction within 3 months prior to randomization
  6. Coronary angioplasty or bypass surgery within 3 months prior to randomization
  7. Uncontrolled hypertension (defined as post-dialysis blood pressure >170/110 mmHg for patients within 0.5 kg of dry weight) within 4 weeks prior to randomization
  8. Known, clinically manifested deficiency of folic acid and/or vitamin B12 (irrespective whether currently treated or not)
  9. 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 microbial, viral, or fungal infection or mental disease (including demyelinating diseases such as multiple sclerosis)
  10. 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
  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: NCT01473420

  Show 41 Study Locations
Sponsors and Collaborators
Hospira, Inc.
  More Information

No publications provided

Responsible Party: Hospira, Inc.
ClinicalTrials.gov Identifier: NCT01473420     History of Changes
Other Study ID Numbers: EPOE-10-13
Study First Received: November 2, 2011
Last Updated: May 14, 2014
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 October 23, 2014