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



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 80
Updated:3/20/2019
Start Date:May 31, 2012
End Date:February 13, 2015

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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

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.


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.
We found this trial at
114
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Van Nuys, California 91405
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Pembroke Pines, Florida 33028
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Arvada, Colorado 80002
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Augusta, Georgia 30901
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Austin, TX
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12221 Renfert Way
Austin, Texas 78758
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Austin, Texas 78751
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Azusa, California 91702
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Bakersfield, California 93308
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3711 Long Beach Boulevard
Bakersfield, California 93309
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Bellflower, California 90706
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Belton, MO
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Belton, Missouri 66012
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Cedar Park, Texas 78613
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Cincinnati, Ohio 45206
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College Point, NY
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Florissant, Missouri 63033
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Flushing, NY
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Fresh Meadows, New York 11365
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Granada Hills, California 91344
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550 South Carrier Parkway
Grand Prairie, Texas 75051
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Grovetown, Georgia 30813
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Houston, TX
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6886 South Texas 6
Houston, Texas 77083
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Houston, Texas 77099
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Kalamazoo, MI
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2901 East Kilgore Road
Kalamazoo, Michigan 49001
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Kalamazoo, Michigan 49007
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Kalamazoo, Michigan 49007
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Kalamazoo, Michigan 49009
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5010 Gull Road
Kalamazoo, Michigan 49048
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Knoxville, TN
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Knoxville, Tennessee 37921
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Knoxville, Tennessee 37923
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Lafayette, Louisiana 70501
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Lafayette, Louisiana 70503
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Lakewood, California 90712
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3780 Kilroy Airport Way
Long Beach, California 90806
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1045 Atlantic Avenue
Long Beach, California 90813
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Long Beach, California 90813
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Los Angeles, California 90022
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Los Angeles, California 90022
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Lufkin, Texas 75904
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Modesto, CA
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305 East Granger Avenue
Modesto, California 95350
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5933 Stoddard Road
Modesto, California 95350
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Normandy, Missouri 63121
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North Brunswick, New Jersey 08902
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1405 West F Street
Oakdale, California 95361
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528 East Vine Street
Opelousas, Louisiana 70570
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Panorama City, California 91402
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Paramount, California 90723
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Perry, Georgia 31069
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Raleigh, North Carolina 27609
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Raleigh, North Carolina 27609
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Richmond, Virginia 23231
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Saint Ann, Missouri 63074
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Saint Louis, Missouri 63136
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