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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT01628120
First received: June 22, 2012
Last updated: June 12, 2015
Last verified: June 2015
  Purpose

To determine the long term safety in treatment-emergent adverse events (TEAEs) of SC administration of Epoetin Hospira for maintenance of target hemoglobin (Hgb) 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, Open-Label, Multicenter, 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 every day up 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 post-dialysis dry body weight over 48 weeks and for each 12-week period.

  • Mean hemoglobin levels [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    Mean Hgb 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.

  • Proportion of patients with Hgb measurement outside the target range [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    Proportion of patients with any Hgb measurement outside the target range during the Treatment Period.

  • Percentage of patients receiving blood transfusions [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    Percentage of patients receiving blood transfusions during the Treatment Period.


Enrollment: 173
Study Start Date: May 2012
Study Completion Date: February 2015
Primary Completion Date: February 2015 (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:

  1. 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.
  2. Patient previously completed the core study 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.
  3. If female, patient must be postmenopausal for at least 1 year prior to enrollment, 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 enrollment
    • intrauterine device
    • 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 enrollment. 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 open-label dose.

  4. Adequate methods of contraception to prevent pregnancy are to be maintained throughout the course of the study in both male and female study subjects.

Exclusion Criteria:

  1. 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.
  2. Any of the following that developed during the core study and prior to enrollment:

    • 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)
  3. A patient with any active, uncontrolled systemic, inflammatory, or malignant disease that developed during the core study and 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.
  4. Any newly developed 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 study participation.
  5. A female patient who is pregnant, lactating, or planning a pregnancy during the study.
  6. History of drug abuse or alcohol abuse during the core study prior to enrollment as determined by the Investigator.
  7. Current participation or participation in a drug or other investigational research study within 30 days prior to enrollment (except the core study or any observational studies with prior written approval from Hospira).
  8. 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.
  9. Evidence of human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg).
  10. A patient who, in the Investigator's opinion, has any clinically significant abnormal laboratory results that may impact patient safety.
  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 33 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: June 12, 2015
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
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 01, 2015