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

Chronic Renal Failure Requiring Hemodialysis Clinical Trial

— AiME - 03  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01628107
• Other study ID #: EPOE-11-03
• Secondary ID: C3461004
• Status: Completed
• Phase: Phase 3
• Start date: July 16, 2012
• Est. completion date: January 2, 2015

Study information

• Verified date: June 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 406
• Est. completion date: January 2, 2015
• Est. primary completion date: January 2, 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 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.

Related Conditions & MeSH terms

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

Intervention

Biological:
• Epoetin Hospira
Intravenous (IV) injection

Locations

Country	Name	City	State
Puerto Rico	Consolidated Medical Plaza	Caguas
Puerto Rico	Fresenius Medical Care·Humacao	Humacao
United States	Anderson Dialysis Clinic	Anderson	South Carolina
United States	AnMed Health	Anderson	South Carolina
United States	Nephrology and Internal Medicine of Anderson	Anderson	South Carolina
United States	Asheville Kidney Center	Asheville	North Carolina
United States	Mountain Kidney and Hypertension Associates, P A	Asheville	North Carolina
United States	Innovative Medical Research of South Florida, Inc,	Aventura	Florida
United States	North America Research Institute	Azusa	California
United States	Bellflower Dialysis Center	Bellflower	California
United States	Biloxi Dialysis	Biloxi	Mississippi
United States	West Boca Dialysis Center	Boca Raton	Florida
United States	Liberty Dialysis/Boise Kidney & Hypertension Institute	Caldwell	Idaho
United States	FMC Ross Englewood Dialysis	Chicago	Illinois
United States	Neomedica South	Chicago	Illinois
United States	Cincinnati VA Medical Center	Cincinnati	Ohio
United States	Clinton Township Dialysis	Clinton Township	Michigan
United States	Columbia Nephrology Associates, P. A.	Columbia	South Carolina
United States	Columbia Nephrology Associates, PA	Columbia	South Carolina
United States	Fresenius Medical Care Columbia JV	Columbia	South Carolina
United States	Fresenius Medical Care Meadowlake JV	Columbia	South Carolina
United States	Fresenius Medical Care SE Columbia JV	Columbia	South Carolina
United States	Fresenius Medical Care South Columbia JV	Columbia	South Carolina
United States	Fresenius Greater Columbus Regional Dialysis Center	Columbus	Ohio
United States	HNC Dialysis, Ltd.	Columbus	Ohio
United States	National Institute of Clinical Research	Commerce	California
United States	DaVita Premier Dialysis Center	Cudahy	California
United States	Grosse Pointe Dialysis	Detroit	Michigan
United States	Renaissance Renal Research Institute, LLC	Detroit	Michigan
United States	Dialysis of Dublin	Dublin	Georgia
United States	Renal Physicians of Georgia, PC	Dublin	Georgia
United States	Gamma Medical Research Inc.	Edinburg	Texas
United States	Davita - South Valley Dialysis	Encino	California
United States	Neomedica Evergreen Park	Evergreen Park	Illinois
United States	Research by Design, LLC	Evergreen Park	Illinois
United States	Fairfield Dialysis Center	Fairfield	California
United States	Ong, Rubin, Shahmir A Medical Corp DBA: Solano Kidney Care	Fairfield	California
United States	Renal Consultants Medical Group	Granada Hills	California
United States	East Carolina University	Greenville	North Carolina
United States	ECU Nephrology and Hypertension	Greenville	North Carolina
United States	FMC/South Mississippi Kidney Center of Gulfport	Gulfport	Mississippi
United States	South Mississippi Medical Research, PLLC	Gulfport	Mississippi
United States	North Suburban Nephrology, LLC	Gurnee	Illinois
United States	Butler Farm Dialysis	Hampton	Virginia
United States	Peninsula Kidney Associates	Hampton	Virginia
United States	DaVita North Park	Houston	Texas
United States	Fresenius Medical Care Kidney Center	Houston	Texas
United States	Med Center Dialysis	Houston	Texas
United States	Meyerland Dialysis	Houston	Texas
United States	Millennium Clinical Research, Inc.	Houston	Texas
United States	North Shepherd Dialysis Center	Houston	Texas
United States	Southwest Houston Dialysis	Houston	Texas
United States	Southwest Houston Research, Ltd.	Houston	Texas
United States	Advanced Medical Research (Administrative)	Lakewood	California
United States	Florida Kidney Center	Lauderhill	Florida
United States	South Florida Research Institute	Laureda Lake	Florida
United States	DaVita Bixby Knolls Dialysis	Long Beach	California
United States	Long Beach Clinical Trials	Long Beach	California
United States	Long Beach Dialysis	Long Beach	California
United States	United Dialysis Center	Long Beach	California
United States	Westcoast Dialysis	Long Beach	California
United States	Dialysis Center of Lubbock	Lubbock	Texas
United States	Imperial Care Dialysis Center	Lynwood	California
United States	Kidney Research Center	Lynwood	California
United States	Coconut Creek Dialysis JV	Margate	Florida
United States	Fresenius Medical Care McAllen	McAllen	Texas
United States	Liberty Dialysis/Boise Kidney & Hypertension Institute	Meridian	Idaho
United States	Pacific Renal Research Institute/Boise Kidney & Hypertension Institute	Meridian	Idaho
United States	Nephrology and Hypertension Associates,PC	Middlebury	Connecticut
United States	Fresenius Medial Care Mission	Mission	Texas
United States	Missouri City Dialysis	Missouri City	Texas
United States	Modesto Kidney Center	Modesto	California
United States	Novo Research d/b/a Foundation Research	Modesto	California
United States	Parkway Kindey Center	Modesto	California
United States	Liberty Dialysis/Boise Kidney & Hypertension Institute	Nampa	Idaho
United States	American Renal Associates Naples Dialysis Center	Naples	Florida
United States	Lower Manhattan Dialysis Center II	New York	New York
United States	Innovative Medical Research of South Florida, Inc.	North Miami Beach	Florida
United States	Physicians Dialysis of North Beach	North Miami Beach	Florida
United States	Oakdale Kidney Center	Oakdale	California
United States	Discovery Medical Research Group, Inc.	Ocala	Florida
United States	Discovery Medical Research Group, Inc.,	Ocala	Florida
United States	Ocala Regional Kidney Center, East	Ocala	Florida
United States	Silver Springs Shores Dialysis Center	Ocala	Florida
United States	National Institute of Clinical Research	Ontario	California
United States	Ontario Dialysis Center	Ontario	California
United States	Paramount Dialysis Center	Paramount	California
United States	Delaware Valley Nephrology and Hypertension Associates, PC	Philadelphia	Pennsylvania
United States	Fresenius Medical Care - Olney Dialysis Center	Philadelphia	Pennsylvania
United States	Fresenius Medical Care- Mt. Airy Kidney Center	Philadelphia	Pennsylvania
United States	Ft. Lauderdale Kidney Center	Plantation	Florida
United States	Plantation Kidney Center	Plantation	Florida
United States	Sierra View Dialysis Center	Porterville	California
United States	Sierra View District Hospital	Porterville	California
United States	Sierra View District Hospital Dialysis Center	Porterville	California
United States	Sierra View Nephrology, Inc.	Porterville	California
United States	Neomedica Round Lake	Round Lake	Illinois
United States	Barnes-Jewish Dialysis Center	Saint Louis	Missouri
United States	Chromalloy American Kidney Center Washington University School of Medicine	Saint Louis	Missouri
United States	Floyd Curl DaVita Dialysis Center	San Antonio	Texas
United States	NW Medical Center DaVita Dialysis	San Antonio	Texas
United States	San Antonio Kidney Disease Center Physicians Group, P.L.L.C.	San Antonio	Texas
United States	Sumter Dialysis Clinic	Sumter	South Carolina
United States	Tamarac Kidney Center	Tamarac	Florida
United States	Nephrology Educational Services and Research, Inc	Tarzana	California
United States	Santa Clarita Kidney Center	Valencia	California
United States	Greater Waterbury Dialysis	Waterbury	Connecticut
United States	Waterbury Dialysis Center	Waterbury	Connecticut
United States	American Institute of Research	Whittier	California
United States	Santa Fe Springs Dialysis	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Puerto Rico, 

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 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, nose, throat, head, neck, thyroid, lungs, chest, abdomen, extremities, lymphatic, cardiovascular, musculoskeletal and neurological systems. Participants for any clinically significant changes in physical examination were based on the investigator's discretion.	Baseline up to Week 48
Other	Percentage of Participants With Anti-Recombinant Human Erythropoietin (Anti-rhEPO) Antibodies	Percentage of participants with at least 1 positive anti-rhEPO antibody were reported. Radioimmunoprecipitation assay 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 the 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