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

Phase 3

Completed

Conditions: Chronic Renal Failure Requiring Hemodialysis

Interventions: Biological: Epoetin Hospira

Registration Number: NCT01628120

Lead Sponsor: Pfizer

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 170

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 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.
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.
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

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.
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)
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.
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.
A female patient who is pregnant, lactating, or planning a pregnancy during the study.
History of drug abuse or alcohol abuse during the core study prior to enrollment as determined by the Investigator.
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).
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.
Evidence of human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg).
A patient who, in the Investigator's opinion, has any clinically significant abnormal laboratory results that may impact patient safety.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Epoetin Hospira	Epoetin Hospira	Epoetin Hospira will be administered by SC bolus injection 1 to 3 times per week per each patient's dosing schedule. Other ESAs (except for long-acting) may be used as rescue therapy.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 12	Week 1 up to Week 12	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Week 1	Up through 7 days after first dose of study drug (Week 1)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 13 to 24	Week 13 up to Week 24	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 25 to 36	Week 25 up to Week 36	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 37 to 48	Week 37 up to Week 48	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 48	Week 1 up to Week 48	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.

Secondary Outcome Measures

Name	Time	Method
Mean Hemoglobin Levels: Over Week 1 to 48	Week 1 up to Week 48
Mean Weekly Dosage of Epoetin Hospira: Over Week 1 to 48	Week 1 up to Week 48
Mean Weekly Dosage of Epoetin Hospira for Interval of 12 Weeks	Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48
Mean Hematocrit Levels for Interval of 12 Weeks	Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48	Hematocrit is defined as the percentage of red blood cells in the blood.
Percentage of Participants With Hemoglobin Level Outside Target Range	Week 1 up to Week 48	Percentage of participants with hemoglobin level outside the target range of 9.0 to 11.0 g/dL were reported.
Percentage of Participants Who Received Blood Transfusions	Week 1 up to Week 48
Mean Hemoglobin Levels for Interval of 12 Weeks	Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48
Mean Hematocrit Levels: Over Week 1 to 48	Week 1 up to Week 48	Hematocrit is defined as the percentage of red blood cells in the blood.

Trial Locations

Locations (80): Pegasus Dialysis
🇺🇸
Bakersfield, California, United States
Azusa Dialysis Center
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Azusa, California, United States
Bellflower Dialysis Center
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Bellflower, California, United States
National Institute of Clinical Research
🇺🇸
Bakersfield, California, United States
Westcoast Dialysis
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Long Beach, California, United States
Modesto Kidney Center
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Modesto, California, United States
Lakewood Dialysis Center
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Lakewood, California, United States
Academic Medical Research Institute
🇺🇸
Los Angeles, California, United States
Novo Research
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Long Beach, California, United States
Novo Research, Inc. d/b/a Foundation Research
🇺🇸
Modesto, California, United States
Norwalk Dialysis Center
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Norwalk, California, United States
intercommunity Dialysis Center
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Whittier, California, United States
Parkway Kidney Center
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Modesto, California, United States
Kidney Center of westminster, LLC
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Westminster, Colorado, United States
US Renal Care of Panorama City
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Panorama City, California, United States
East Macon Dialysis
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Macon, Georgia, United States
Fresenius Medical Care - Kalamazoo
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Kalamazoo, Michigan, United States
Dialysis Clinics, Inc. - Belton
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Belton, Missouri, United States
Perry Dialysis Center
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Perry, Georgia, United States
Nephrology Centers of America - Augusta (NCA-A)
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Augusta, Georgia, United States
Kidney Care Associates, LLC
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Augusta, Georgia, United States
Cedar Bluff Dialysis
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Knoxville, Tennessee, United States
Mission Bend Dialysis
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Houston, Texas, United States
Pines Clinical Research, Inc.
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Pembroke Pines, Florida, United States
Western Nephrology and Metabolic Bone Disease, PC
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Westminster, Colorado, United States
Renal Physicians of Georgia, PC
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Macon, Georgia, United States
FMC Normandy Dialysis
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Normandy, Missouri, United States
Nephrology Center DBA Paragon Health PC
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Kalamazoo, Michigan, United States
Grovetown Dialysis Center
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Grovetown, Georgia, United States
Nephrology Centers of America (NCA) South Augusta
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Augusta, Georgia, United States
Kansas Nephrology Research Institute, LLC
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Wichita, Kansas, United States
Trude Weishaupt Memorial Dialysis Center
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Fresh Meadows, New York, United States
Fresenius Medical Care- Kalamazoo East
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Kalamazoo, Michigan, United States
Kennedy Dialysis Center
🇺🇸
Voorhees, New Jersey, United States
Fresenius Medical Care - Oshtermo
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Kalamazoo, Michigan, United States
Wake Dialysis Clinic
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Raleigh, North Carolina, United States
FMC St. Louis Regional Dialysis
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Saint Ann, Missouri, United States
Metro Hypertension and Kidney Center
🇺🇸
Saint Louis, Missouri, United States
FMC Metro North Dialysis
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Florissant, Missouri, United States
Nephrology Specialists, P.C.
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Mechanicsville, Virginia, United States
Grand Prairie Dialysis Center
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Grand Prairie, Texas, United States
Knoxville Kidney Center, PLLC
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Knoxville, Tennessee, United States
Toledo Hospital, Promedica Health System
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Toledo, Ohio, United States
Las Palmas Davita Dialysis Center
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San Antonio, Texas, United States
Fresenius Medical Care - Cedar Park
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Cedar Park, Texas, United States
Innovative Dialysis of Toledo
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Toledo, Ohio, United States
DCI McMillan
🇺🇸
Cincinnati, Ohio, United States
San Antonio Kidney Disease Center Physicians Group, P.L.L.C.
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San Antonio, Texas, United States
Long Beach Dialysis
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Long Beach, California, United States
East LA Dialysis Center
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Los Angeles, California, United States
Oakdale Kidney Center
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Oakdale, California, United States
US Renal Care of Northridge
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Northridge, California, United States
Paramount Dialysis Center
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Paramount, California, United States
California Kidney Medical Group
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Simi Valley, California, United States
US Renal Care of Van Nuys
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Van Nuys, California, United States
American Institute of Research
🇺🇸
Whittier, California, United States
Fresenius Medical Care- Gull Road
🇺🇸
Kalamazoo, Michigan, United States
Wake Nephrology Associates, PA
🇺🇸
Raleigh, North Carolina, United States
Alexis Dialysis Center
🇺🇸
Toledo, Ohio, United States
The Center for Hypertension and Nephrology Care
🇺🇸
Meadville, Pennsylvania, United States
Southwest Houston Research, Ltd.
🇺🇸
Houston, Texas, United States
Mohammad Ismail MD, Inc.
🇺🇸
Paramount, California, United States
Canyon Country Dialysis Center
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Santa Clarita, California, United States
FMC Opelousas
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Opelousas, Louisiana, United States
Waynesboro Dialysis Center
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Waynesboro, Georgia, United States
meadville Dialysis
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Meadville, Pennsylvania, United States
Wildwood Dialysis Center
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Toledo, Ohio, United States
SNG Dialysis Center of Lufkin
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Lufkin, Texas, United States
ARA Mechanicsville Dialysis
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Mechanicsville, Virginia, United States
Dialysis Clinic Incorporated
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North Brunswick, New Jersey, United States
Fresenius Medical Care
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Knoxville, Tennessee, United States
ARA South Laburnum Dialysis
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Richmond, Virginia, United States
Fresenius Medical Care-Austin North Dialysis
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Austin, Texas, United States
Research Management Inc.
🇺🇸
Austin, Texas, United States
Research Management, Inc.
🇺🇸
Austin, Texas, United States
Fresenius Medical Care Midtown #8498
🇺🇸
Wichita, Kansas, United States
FMC Northside
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Lafayette, Louisiana, United States
Whittier Kidney Dialysis Center
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Whittier, California, United States
Kidney Center of Arvada
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Arvada, Colorado, United States
Research Nurse Specialists ,LLC
🇺🇸
Lafayette, Louisiana, United States