Clinical trial NCT01628107: A Phase 3, Long-Term Safety Study of Intravenous Epoetin Hospira in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin
Official title: A Phase III, Open-label, Multicenter, Long-term Safety Study Of Intravenous 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: 406
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: The purpose of the study is to determine the long-term safety in treatment-emergent adverse events (TEAEs) of intravenous (IV) 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 Treatment Period up to and including Week 24 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 the 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 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 (Anti-rhEPO) Antibodies
timeFrame: Baseline, Week 48
Locations:
city: Azusa
country: United States
facility: North America Research Institute
state: California
city: Bellflower
country: United States
facility: Bellflower Dialysis Center
state: California
city: Commerce
country: United States
facility: National Institute of Clinical Research
state: California
city: Cudahy
country: United States
facility: DaVita Premier Dialysis Center
state: California
city: Encino
country: United States
facility: Davita - South Valley Dialysis
state: California
city: Fairfield
country: United States
facility: Ong, Rubin, Shahmir A Medical Corp DBA: Solano Kidney Care
state: California
city: Fairfield
country: United States
facility: Fairfield Dialysis Center
state: California
city: Granada Hills
country: United States
facility: Renal Consultants Medical Group
state: California
city: Lakewood
country: United States
facility: Advanced Medical Research (Administrative)
state: California
city: Long Beach
country: United States
facility: Long Beach Clinical Trials
state: California
city: Long Beach
country: United States
facility: Westcoast Dialysis
state: California
city: Long Beach
country: United States
facility: DaVita Bixby Knolls Dialysis
state: California
city: Long Beach
country: United States
facility: United Dialysis Center
state: California
city: Long Beach
country: United States
facility: Long Beach Dialysis
state: California
city: Lynwood
country: United States
facility: Imperial Care Dialysis Center
state: California
city: Lynwood
country: United States
facility: Kidney Research Center
state: California
city: Modesto
country: United States
facility: Modesto Kidney Center
state: California
city: Modesto
country: United States
facility: Novo Research d/b/a Foundation Research
state: California
city: Modesto
country: United States
facility: Parkway Kindey Center
state: California
city: Oakdale
country: United States
facility: Oakdale Kidney Center
state: California
city: Ontario
country: United States
facility: National Institute of Clinical Research
state: California
city: Ontario
country: United States
facility: Ontario Dialysis Center
state: California
city: Paramount
country: United States
facility: Paramount Dialysis Center
state: California
city: Porterville
country: United States
facility: Sierra View Dialysis Center
state: California
city: Porterville
country: United States
facility: Sierra View District Hospital Dialysis Center
state: California
city: Porterville
country: United States
facility: Sierra View District Hospital
state: California
city: Porterville
country: United States
facility: Sierra View Nephrology, Inc.
state: California
city: Tarzana
country: United States
facility: Nephrology Educational Services and Research, Inc
state: California
city: Valencia
country: United States
facility: Santa Clarita Kidney Center
state: California
city: Whittier
country: United States
facility: American Institute of Research
state: California
city: Whittier
country: United States
facility: Santa Fe Springs Dialysis
state: California
city: Middlebury
country: United States
facility: Nephrology and Hypertension Associates,PC
state: Connecticut
city: Waterbury
country: United States
facility: Waterbury Dialysis Center
state: Connecticut
city: Waterbury
country: United States
facility: Greater Waterbury Dialysis
state: Connecticut
city: Aventura
country: United States
facility: Innovative Medical Research of South Florida, Inc,
state: Florida
city: Boca Raton
country: United States
facility: West Boca Dialysis Center
state: Florida
city: Lauderhill
country: United States
facility: Florida Kidney Center
state: Florida
city: Laureda Lake
country: United States
facility: South Florida Research Institute
state: Florida
city: Margate
country: United States
facility: Coconut Creek Dialysis JV
state: Florida
city: Naples
country: United States
facility: American Renal Associates Naples Dialysis Center
state: Florida
city: North Miami Beach
country: United States
facility: Innovative Medical Research of South Florida, Inc.
state: Florida
city: North Miami Beach
country: United States
facility: Physicians Dialysis of North Beach
state: Florida
city: Ocala
country: United States
facility: Discovery Medical Research Group, Inc.,
state: Florida
city: Ocala
country: United States
facility: Discovery Medical Research Group, Inc.
state: Florida
city: Ocala
country: United States
facility: Ocala Regional Kidney Center, East
state: Florida
city: Ocala
country: United States
facility: Silver Springs Shores Dialysis Center
state: Florida
city: Plantation
country: United States
facility: Ft. Lauderdale Kidney Center
state: Florida
city: Plantation
country: United States
facility: Plantation Kidney Center
state: Florida
city: Tamarac
country: United States
facility: Tamarac Kidney Center
state: Florida
city: Dublin
country: United States
facility: Dialysis of Dublin
state: Georgia
city: Dublin
country: United States
facility: Renal Physicians of Georgia, PC
state: Georgia
city: Caldwell
country: United States
facility: Liberty Dialysis/Boise Kidney & Hypertension Institute
state: Idaho
city: Meridian
country: United States
facility: Liberty Dialysis/Boise Kidney & Hypertension Institute
state: Idaho
city: Meridian
country: United States
facility: Pacific Renal Research Institute/Boise Kidney & Hypertension Institute
state: Idaho
city: Nampa
country: United States
facility: Liberty Dialysis/Boise Kidney & Hypertension Institute
state: Idaho
city: Chicago
country: United States
facility: Neomedica South
state: Illinois
city: Chicago
country: United States
facility: FMC Ross Englewood Dialysis
state: Illinois
city: Evergreen Park
country: United States
facility: Neomedica Evergreen Park
state: Illinois
city: Evergreen Park
country: United States
facility: Research by Design, LLC
state: Illinois
city: Gurnee
country: United States
facility: North Suburban Nephrology, LLC
state: Illinois
city: Round Lake
country: United States
facility: Neomedica Round Lake
state: Illinois
city: Clinton Township
country: United States
facility: Clinton Township Dialysis
state: Michigan
city: Detroit
country: United States
facility: Grosse Pointe Dialysis
state: Michigan
city: Detroit
country: United States
facility: Renaissance Renal Research Institute, LLC
state: Michigan
city: Biloxi
country: United States
facility: Biloxi Dialysis
state: Mississippi
city: Gulfport
country: United States
facility: FMC/South Mississippi Kidney Center of Gulfport
state: Mississippi
city: Gulfport
country: United States
facility: South Mississippi Medical Research, PLLC
state: Mississippi
city: Saint Louis
country: United States
facility: Barnes-Jewish Dialysis Center
state: Missouri
city: Saint Louis
country: United States
facility: Chromalloy American Kidney Center Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: Lower Manhattan Dialysis Center II
state: New York
city: Asheville
country: United States
facility: Mountain Kidney and Hypertension Associates, P A
state: North Carolina
city: Asheville
country: United States
facility: Asheville Kidney Center
state: North Carolina
city: Greenville
country: United States
facility: ECU Nephrology and Hypertension
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati VA Medical Center
state: Ohio
city: Columbus
country: United States
facility: Fresenius Greater Columbus Regional Dialysis Center
state: Ohio
city: Columbus
country: United States
facility: HNC Dialysis, Ltd.
state: Ohio
city: Philadelphia
country: United States
facility: Delaware Valley Nephrology and Hypertension Associates, PC
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fresenius Medical Care- Mt. Airy Kidney Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fresenius Medical Care - Olney Dialysis Center
state: Pennsylvania
city: Anderson
country: United States
facility: Anderson Dialysis Clinic
state: South Carolina
city: Anderson
country: United States
facility: AnMed Health
state: South Carolina
city: Anderson
country: United States
facility: Nephrology and Internal Medicine of Anderson
state: South Carolina
city: Columbia
country: United States
facility: Columbia Nephrology Associates, P. A.
state: South Carolina
city: Columbia
country: United States
facility: Columbia Nephrology Associates, PA
state: South Carolina
city: Columbia
country: United States
facility: Fresenius Medical Care Columbia JV
state: South Carolina
city: Columbia
country: United States
facility: Fresenius Medical Care Meadowlake JV
state: South Carolina
city: Columbia
country: United States
facility: Fresenius Medical Care South Columbia JV
state: South Carolina
city: Columbia
country: United States
facility: Fresenius Medical Care SE Columbia JV
state: South Carolina
city: Sumter
country: United States
facility: Sumter Dialysis Clinic
state: South Carolina
city: Edinburg
country: United States
facility: Gamma Medical Research Inc.
state: Texas
city: Houston
country: United States
facility: Med Center Dialysis
state: Texas
city: Houston
country: United States
facility: Fresenius Medical Care Kidney Center
state: Texas
city: Houston
country: United States
facility: Meyerland Dialysis
state: Texas
city: Houston
country: United States
facility: Millennium Clinical Research, Inc.
state: Texas
city: Houston
country: United States
facility: Southwest Houston Dialysis
state: Texas
city: Houston
country: United States
facility: DaVita North Park
state: Texas
city: Houston
country: United States
facility: North Shepherd Dialysis Center
state: Texas
city: Houston
country: United States
facility: Southwest Houston Research, Ltd.
state: Texas
city: Lubbock
country: United States
facility: Dialysis Center of Lubbock
state: Texas
city: McAllen
country: United States
facility: Fresenius Medical Care McAllen
state: Texas
city: Mission
country: United States
facility: Fresenius Medial Care Mission
state: Texas
city: Missouri City
country: United States
facility: Missouri City Dialysis
state: Texas
city: San Antonio
country: United States
facility: NW Medical Center DaVita Dialysis
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: Floyd Curl DaVita Dialysis Center
state: Texas
city: Hampton
country: United States
facility: Butler Farm Dialysis
state: Virginia
city: Hampton
country: United States
facility: Peninsula Kidney Associates
state: Virginia
city: Caguas
country: Puerto Rico
facility: Consolidated Medical Plaza
city: Humacao
country: Puerto Rico
facility: Fresenius Medical Care·Humacao
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.