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

Chronic Renal Failure Requiring Hemodialysis Clinical Trial

— AiME - 04  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01628120
• Other study ID #: EPOE-11-04
• Secondary ID: C3461005
• Status: Completed
• Phase: Phase 3
• Start date: May 31, 2012
• Est. completion date: February 13, 2015

Study information

• Verified date: February 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: February 13, 2015
• Est. primary completion date: February 13, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Renal Failure Requiring Hemodialysis
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Biological:
• Epoetin Hospira
Subcutaneous(SC) injection

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL)		Week 1 up to Week 48
Other	Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL)		Week 1 up to Week 48
Other	Number of Participants With Clinically Significant Change From Baseline in Hemoglobin (Hb) Levels	Participants with clinically significant change from baseline in hemoglobin levels were upon investigator's discretion.	Baseline up to Week 48
Other	Number of Participants Who Received Concomitant Medication		Week 1 up to Week 48
Other	Number of Participants With Clinically Significant Change From Baseline in Laboratory Tests	Laboratory tests included: Hematology (hematocrit, hemoglobin, red blood cells count, reticulocytes, white blood cells count, neutrophils, bands, lymphocytes, monocytes, basophils, eosinophils, platelets, mean corpuscular volume); Coagulation panel (prothrombin time, international normalized ratio, activated partial thromboplastin time); Chemistry (blood urine nitrogen, creatinine, total bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, calcium, gamma-glutyl transpeptidase, phosphorus, uric acid, total protein, glucose, albumin, C-reactive protein); iron status (plasma ferritin, transferrin saturation). Participants with clinically significant change from baseline in laboratory tests were based on investigator's discretion.	Baseline up to Week 48
Other	Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiogram (ECG)	ECG parameters included: PR interval, QRS complex, QT interval and QTC interval. Participants with clinically significant change from baseline in 12-lead ECGs were based on investigator's discretion.	Baseline up to Week 48
Other	Number of Participants With Clinically Significant Change From Baseline in Physical Examinations	Physical examination included examination of the skin, eyes, ears, throat, neck, and cardiac, respiratory, gastrointestinal and musculoskeletal systems. The examination assessed the participants for any clinically significant changes in physical status, as determined by the investigator.	Baseline up to Week 48
Other	Percentage of Participants With Anti-Recombinant Human Erythropoietin (rhEPO) Antibodies	Percentage of participants with at least 1 positive anti-rhEPO antibodies were reported. Radioimmunoprecipitation assay method was used to determine the presence of anti-rhEPO antibodies.	Baseline, Week 48
Primary	Percentage of Participants With Treatment Emergent Adverse Events (AEs): 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.	Up through 7 days after first dose of study drug (Week 1)
Primary	Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 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.	Week 1 up to Week 12
Primary	Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 13 to 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.	Week 13 up to Week 24
Primary	Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 25 to 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.	Week 25 up to Week 36
Primary	Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 37 to 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.	Week 37 up to Week 48
Primary	Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 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.	Week 1 up to Week 48
Secondary	Mean Weekly Dosage of Epoetin Hospira: Over Week 1 to 48		Week 1 up to Week 48
Secondary	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
Secondary	Mean Hemoglobin Levels: Over Week 1 to 48		Week 1 up to Week 48
Secondary	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
Secondary	Mean Hematocrit Levels: Over Week 1 to 48	Hematocrit is defined as the percentage of red blood cells in the blood.	Week 1 up to Week 48
Secondary	Mean Hematocrit Levels for Interval of 12 Weeks	Hematocrit is defined as the percentage of red blood cells in the blood.	Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48
Secondary	Percentage of Participants With Hemoglobin Level Outside Target Range	Percentage of participants with hemoglobin level outside the target range of 9.0 to 11.0 g/dL were reported.	Week 1 up to Week 48
Secondary	Percentage of Participants Who Received Blood Transfusions		Week 1 up to Week 48