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 - Full Text View

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:

MedlinePlus related topics: Anemia Dialysis Kidney Failure

Drug Information available for: Erythropoietin Epoetin Alfa

U.S. FDA Resources

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 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 75 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 EPOE-10-13 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) within 3 months prior to enrollment
Cerebrovascular accident within 3 months prior to enrollment
Myocardial infarction within 3 months prior to enrollment
Coronary angioplasty or bypass surgery within 3 months prior to enrollment
Uncontrolled hypertension (defined as post-dialysis blood pressure >170/110 mmHg) within 4 weeks prior to enrollment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01628120

Contacts

Contact: Seema Kumbhat, MD	224-212-6846	seema.kumbhat@hospira.com
Contact: Clarice Anania	224-212-4596	clarice.anania@hospira.com

Locations

United States, California
	Recruiting
Bakersfield, California, United States, 93308
	Recruiting
Granada Hills, California, United States, 91344
	Recruiting
Los Angeles, California, United States, 90022
	Recruiting
Paramount, California, United States, 90723
	Recruiting
Whittier, California, United States, 90603
United States, Florida
	Recruiting
Pembroke Pines, Florida, United States, 33028
United States, Georgia
	Recruiting
Augusta, Georgia, United States, 30901
	Recruiting
Macon, Georgia, United States, 31217
United States, Louisiana
	Recruiting
Lafayette, Louisiana, United States, 70503
United States, Missouri
	Recruiting
Saint Louis, Missouri, United States, 63136
United States, New Jersey
	Recruiting
Voorhees, New Jersey, United States, 08043
United States, New York
	Recruiting
Fresh Meadows, New York, United States, 11365
United States, North Carolina
	Recruiting
Releigh, North Carolina, United States, 27609
United States, Ohio
	Recruiting
Toledo, Ohio, United States, 43606
United States, Pennsylvania
	Recruiting
Meadville, Pennsylvania, United States, 16335
United States, Tennessee
	Recruiting
Knoxville, Tennessee, United States, 37923
United States, Texas
	Recruiting
Austin, Texas, United States, 78758
	Recruiting
Grand Prarie, Texas, United States, 75051
	Recruiting
San Antonio, Texas, United States, 78237
United States, Virginia
	Recruiting
Mechanicsville, Virginia, United States, 23116

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 17, 2013
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 May 19, 2013

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)