Clinical trial NCT01628120: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Renal Failure Requiring Hemodialysis
Keywords: Chronic renal failure
Hemodialysis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-06-26
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants With Treatment Emergent Adverse Events (AEs): Week 1
timeFrame: Up through 7 days after first dose of study drug (Week 1)
measure: Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 12
timeFrame: Week 1 up to Week 12
measure: Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 13 to 24
timeFrame: Week 13 up to Week 24
measure: Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 25 to 36
timeFrame: Week 25 up to Week 36
measure: Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 37 to 48
timeFrame: Week 37 up to Week 48
measure: Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 48
timeFrame: Week 1 up to Week 48
Secondary outcomes:
measure: Mean Weekly Dosage of Epoetin Hospira: Over Week 1 to 48
timeFrame: Week 1 up to Week 48
measure: Mean Weekly Dosage of Epoetin Hospira for Interval of 12 Weeks
timeFrame: Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48
measure: Mean Hemoglobin Levels: Over Week 1 to 48
timeFrame: Week 1 up to Week 48
measure: Mean Hemoglobin Levels for Interval of 12 Weeks
timeFrame: Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48
measure: Mean Hematocrit Levels: Over Week 1 to 48
timeFrame: Week 1 up to Week 48
measure: Mean Hematocrit Levels for Interval of 12 Weeks
timeFrame: Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48
measure: Percentage of Participants With Hemoglobin Level Outside Target Range
timeFrame: Week 1 up to Week 48
measure: Percentage of Participants Who Received Blood Transfusions
timeFrame: Week 1 up to Week 48
Other outcomes:
measure: Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL)
timeFrame: Week 1 up to Week 48
measure: Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL)
timeFrame: Week 1 up to Week 48
measure: Number of Participants With Clinically Significant Change From Baseline in Hemoglobin (Hb) Levels
timeFrame: Baseline up to Week 48
measure: Number of Participants Who Received Concomitant Medication
timeFrame: Week 1 up to Week 48
measure: Number of Participants With Clinically Significant Change From Baseline in Laboratory Tests
timeFrame: Baseline up to Week 48
measure: Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiogram (ECG)
timeFrame: Baseline up to Week 48
measure: Number of Participants With Clinically Significant Change From Baseline in Physical Examinations
timeFrame: Baseline up to Week 48
measure: Percentage of Participants With Anti-Recombinant Human Erythropoietin (rhEPO) Antibodies
timeFrame: Baseline, Week 48
Locations:
city: Azusa
country: United States
facility: Azusa Dialysis Center
state: California
city: Azusa
country: United States
state: California
city: Bakersfield
country: United States
facility: Pegasus Dialysis
state: California
city: Bakersfield
country: United States
facility: National Institute of Clinical Research
state: California
city: Bakersfield
country: United States
state: California
city: Bellflower
country: United States
facility: Bellflower Dialysis Center
state: California
city: Granada Hills
country: United States
state: California
city: Lakewood
country: United States
facility: Lakewood Dialysis Center
state: California
city: Long Beach
country: United States
facility: Westcoast Dialysis
state: California
city: Long Beach
country: United States
facility: Long Beach Dialysis
state: California
city: Long Beach
country: United States
facility: Novo Research
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
facility: Academic Medical Research Institute
state: California
city: Los Angeles
country: United States
facility: East LA Dialysis Center
state: California
city: Los Angeles
country: United States
state: California
city: Modesto
country: United States
facility: Modesto Kidney Center
state: California
city: Modesto
country: United States
facility: Novo Research, Inc. d/b/a Foundation Research
state: California
city: Modesto
country: United States
facility: Parkway Kidney Center
state: California
city: Modesto
country: United States
state: California
city: Northridge
country: United States
facility: US Renal Care of Northridge
state: California
city: Northridge
country: United States
state: California
city: Norwalk
country: United States
facility: Norwalk Dialysis Center
state: California
city: Oakdale
country: United States
facility: Oakdale Kidney Center
state: California
city: Panorama City
country: United States
facility: US Renal Care of Panorama City
state: California
city: Paramount
country: United States
facility: Mohammad Ismail MD, Inc.
state: California
city: Paramount
country: United States
facility: Paramount Dialysis Center
state: California
city: Paramount
country: United States
state: California
city: Santa Clarita
country: United States
facility: Canyon Country Dialysis Center
state: California
city: Simi Valley
country: United States
facility: California Kidney Medical Group
state: California
city: Van Nuys
country: United States
facility: US Renal Care of Van Nuys
state: California
city: Whittier
country: United States
facility: intercommunity Dialysis Center
state: California
city: Whittier
country: United States
facility: American Institute of Research
state: California
city: Whittier
country: United States
facility: Whittier Kidney Dialysis Center
state: California
city: Whittier
country: United States
state: California
city: Arvada
country: United States
facility: Kidney Center of Arvada
state: Colorado
city: Arvada
country: United States
facility: Western Nephrology and Metabolic Bone Disease, PC
state: Colorado
city: Arvada
country: United States
state: Colorado
city: Westminster
country: United States
facility: Kidney Center of westminster, LLC
state: Colorado
city: Westminster
country: United States
facility: Western Nephrology and Metabolic Bone Disease, PC
state: Colorado
city: Westminster
country: United States
state: Colorado
city: Pembroke Pines
country: United States
facility: Pines Clinical Research, Inc.
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Augusta
country: United States
facility: Nephrology Centers of America - Augusta (NCA-A)
state: Georgia
city: Augusta
country: United States
state: Georgia
city: Augusta
country: United States
facility: Nephrology Centers of America (NCA) South Augusta
state: Georgia
city: Augusta
country: United States
facility: Kidney Care Associates, LLC
state: Georgia
city: Grovetown
country: United States
facility: Grovetown Dialysis Center
state: Georgia
city: Macon
country: United States
facility: East Macon Dialysis
state: Georgia
city: Macon
country: United States
facility: Renal Physicians of Georgia, PC
state: Georgia
city: Macon
country: United States
state: Georgia
city: Perry
country: United States
facility: Perry Dialysis Center
state: Georgia
city: Waynesboro
country: United States
facility: Waynesboro Dialysis Center
state: Georgia
city: Wichita
country: United States
facility: Fresenius Medical Care Midtown #8498
state: Kansas
city: Wichita
country: United States
facility: Kansas Nephrology Research Institute, LLC
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Lafayette
country: United States
facility: FMC Northside
state: Louisiana
city: Lafayette
country: United States
facility: Research Nurse Specialists ,LLC
state: Louisiana
city: Lafayette
country: United States
state: Louisiana
city: Opelousas
country: United States
facility: FMC Opelousas
state: Louisiana
city: Kalamazoo
country: United States
facility: Fresenius Medical Care- Kalamazoo East
state: Michigan
city: Kalamazoo
country: United States
facility: Fresenius Medical Care - Kalamazoo
state: Michigan
city: Kalamazoo
country: United States
facility: Nephrology Center DBA Paragon Health PC
state: Michigan
city: Kalamazoo
country: United States
state: Michigan
city: Kalamazoo
country: United States
facility: Fresenius Medical Care - Oshtermo
state: Michigan
city: Kalamazoo
country: United States
facility: Fresenius Medical Care- Gull Road
state: Michigan
city: Belton
country: United States
state: Missouri
city: Belton
country: United States
facility: Dialysis Clinics, Inc. - Belton
state: Missouri
city: Florissant
country: United States
facility: FMC Metro North Dialysis
state: Missouri
city: Normandy
country: United States
facility: FMC Normandy Dialysis
state: Missouri
city: Saint Ann
country: United States
facility: FMC St. Louis Regional Dialysis
state: Missouri
city: Saint Louis
country: United States
facility: Metro Hypertension and Kidney Center
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: North Brunswick
country: United States
facility: Dialysis Clinic Incorporated
state: New Jersey
city: North Brunswick
country: United States
state: New Jersey
city: Sewell
country: United States
facility: Kennedy Dialysis Center
state: New Jersey
city: Voorhees
country: United States
facility: Kennedy Dialysis Center
state: New Jersey
city: Voorhees
country: United States
state: New Jersey
city: College Point
country: United States
state: New York
city: Flushing
country: United States
state: New York
city: Fresh Meadows
country: United States
facility: Trude Weishaupt Memorial Dialysis Center
state: New York
city: Raleigh
country: United States
facility: Wake Dialysis Clinic
state: North Carolina
city: Raleigh
country: United States
facility: Wake Nephrology Associates, PA
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Cincinnati
country: United States
facility: DCI McMillan
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Toledo
country: United States
facility: Innovative Dialysis of Toledo
state: Ohio
city: Toledo
country: United States
facility: Toledo Hospital, Promedica Health System
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Toledo
country: United States
facility: Alexis Dialysis Center
state: Ohio
city: Toledo
country: United States
facility: Wildwood Dialysis Center
state: Ohio
city: Meadville
country: United States
facility: meadville Dialysis
state: Pennsylvania
city: Meadville
country: United States
facility: The Center for Hypertension and Nephrology Care
state: Pennsylvania
city: Knoxville
country: United States
facility: Fresenius Medical Care
state: Tennessee
city: Knoxville
country: United States
facility: Cedar Bluff Dialysis
state: Tennessee
city: Knoxville
country: United States
facility: Knoxville Kidney Center, PLLC
state: Tennessee
city: Knoxville
country: United States
state: Tennessee
city: Austin
country: United States
facility: Fresenius Medical Care-Austin North Dialysis
state: Texas
city: Austin
country: United States
facility: Research Management Inc.
state: Texas
city: Austin
country: United States
facility: Research Management, Inc.
state: Texas
city: Austin
country: United States
state: Texas
city: Cedar Park
country: United States
facility: Fresenius Medical Care - Cedar Park
state: Texas
city: Grand Prairie
country: United States
facility: Grand Prairie Dialysis Center
state: Texas
city: Grand Prairie
country: United States
state: Texas
city: Houston
country: United States
facility: Mission Bend Dialysis
state: Texas
city: Houston
country: United States
facility: Southwest Houston Research, Ltd.
state: Texas
city: Houston
country: United States
state: Texas
city: Lufkin
country: United States
facility: SNG Dialysis Center of Lufkin
state: Texas
city: Lufkin
country: United States
state: Texas
city: San Antonio
country: United States
facility: San Antonio Kidney Disease Center Physicians Group, P.L.L.C.
state: Texas
city: San Antonio
country: United States
facility: Las Palmas Davita Dialysis Center
state: Texas
city: San Antonio
country: United States
state: Texas
city: Mechanicsville
country: United States
facility: ARA Mechanicsville Dialysis
state: Virginia
city: Mechanicsville
country: United States
facility: Nephrology Specialists, P.C.
state: Virginia
city: Mechanicsville
country: United States
state: Virginia
city: Richmond
country: United States
facility: ARA South Laburnum Dialysis
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Wish JB, Rocha MG, Martin NE, Reyes CRD, Fishbane S, Smith MT, Nassar G. Long-term Safety of Epoetin Alfa-epbx for the Treatment of Anemia in ESKD: Pooled Analyses of Randomized and Open-label Studies. Kidney Med. 2019 Aug 28;1(5):271-280. doi: 10.1016/j.xkme.2019.06.009. eCollection 2019 Sep-Oct.