A Phase 3 Long-Term Safety Study of Subcutaneous Epoetin Hospira in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME -Anemia Management With Epoetin (AiME - 04)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT01628120
First received: June 22, 2012
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

To determine the long term safety in treatment-emergent adverse events (TEAEs) of SC administration of Epoetin Hospira for maintenance of target hemoglobin (Hb) levels in patients treated for anemia associated with chronic renal failure and on hemodialysis.


Condition Intervention Phase
Chronic Renal Failure Requiring Hemodialysis
Biological: Epoetin Hospira
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3 Long-Term Safety Study of Subcutaneous Epoetin Hospira 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:
  • Treatment emergent adverse events [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    The percentage of patients with TEAEs each day through 7 days from the date of the first dose, each 12 week period, and the last day of the Treatment Period


Secondary Outcome Measures:
  • Mean weekly epoetin dosage [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    Mean weekly epoetin dosage per kg body weight over 48 weeks and for each 12 week period

  • Mean hemoglobin levels [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    Mean Hb levels over 48 weeks and for each 12 week period

  • Mean hematocrit levels [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    Mean hematocrit (Hct) levels over 48 weeks and for each 12 week period


Estimated Enrollment: 288
Study Start Date: May 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Epoetin Hospira
Epoetin Hospira will be administered by SC bolus injection 1 to 3 times per week per each patient's dosing schedule.
Biological: Epoetin Hospira
Other ESAs may be used as rescue therapy provided they are not long acting.
Other Names:
  • ESA
  • Erythropoetin Stimulation Agents

  Eligibility

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

Inclusion Criteria:

  • Patient is able to provide written Informed Consent after the risks and benefits of the study have been explained prior to any study related activities
  • Patient previously completed the EPOE 10 13 Maintenance Period up to and including Week 16 study assessments per protocol and is willing to continue open label Epoetin Hospira for up to 48 weeks

Exclusion Criteria:

  • Patient had a serious or severe adverse event in the core study that, in the opinion of the Investigator, was probably or definitely related to epoetin use and precluded safe use of epoetin
  • Decompensated congestive heart failure (New York Heart Association [NYHA] class IV) during the core study
  • Cerebrovascular accident during the core study
  • Myocardial infarction during the core study
  • Coronary angioplasty or bypass surgery during the core study
  • A patient with any active, uncontrolled systemic, inflammatory or malignant disease developing during the core study, 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.

    • May not be able to comply with the requirements of t his clinical study, communicate effectively with study personnel or is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
  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: NCT01628120

  Show 32 Study Locations
Sponsors and Collaborators
Hospira, Inc.
  More Information

No publications provided

Responsible Party: Hospira, Inc.
ClinicalTrials.gov Identifier: NCT01628120     History of Changes
Other Study ID Numbers: EPOE-11-04
Study First Received: June 22, 2012
Last Updated: May 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Hospira, Inc.:
Chronic renal failure
Hemodialysis

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

ClinicalTrials.gov processed this record on July 20, 2014