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

NCT ID: NCT01628107

Last Updated: 2018-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 406 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-16
• Study Completion Date: 2015-01-02

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.

Conditions

Chronic Renal Failure Requiring Hemodialysis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Epoetin Hospira

Epoetin Hospira will be administered by IV 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.

Group Type: EXPERIMENTAL

Epoetin Hospira

Intervention Type: BIOLOGICAL

Intravenous (IV) injection

Interventions

Epoetin Hospira

Intravenous (IV) injection

Intervention Type: BIOLOGICAL

Other Intervention Names

ESA; Erythropoetin Stimulating Agent

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

North America Research Institute

Azusa, California, United States

Bellflower Dialysis Center

Bellflower, California, United States

National Institute of Clinical Research

Commerce, California, United States

DaVita Premier Dialysis Center

Cudahy, California, United States

Davita - South Valley Dialysis

Encino, California, United States

Ong, Rubin, Shahmir A Medical Corp DBA: Solano Kidney Care

Fairfield, California, United States

Fairfield Dialysis Center

Fairfield, California, United States

Renal Consultants Medical Group

Granada Hills, California, United States

Advanced Medical Research (Administrative)

Lakewood, California, United States

Long Beach Clinical Trials

Long Beach, California, United States

Westcoast Dialysis

Long Beach, California, United States

DaVita Bixby Knolls Dialysis

Long Beach, California, United States

United Dialysis Center

Long Beach, California, United States

Long Beach Dialysis

Long Beach, California, United States

Imperial Care Dialysis Center

Lynwood, California, United States

Kidney Research Center

Lynwood, California, 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

Oakdale Kidney Center

Oakdale, California, 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

Sierra View Dialysis Center

Porterville, California, United States

Sierra View District Hospital Dialysis Center

Porterville, California, United States

Sierra View District Hospital

Porterville, California, United States

Sierra View Nephrology, Inc.

Porterville, California, United States

Nephrology Educational Services and Research, Inc

Tarzana, California, United States

Santa Clarita Kidney Center

Valencia, California, United States

American Institute of Research

Whittier, California, United States

Santa Fe Springs Dialysis

Whittier, California, United States

Nephrology and Hypertension Associates,PC

Middlebury, Connecticut, United States

Waterbury Dialysis Center

Waterbury, Connecticut, United States

Greater Waterbury Dialysis

Waterbury, Connecticut, United States

Innovative Medical Research of South Florida, Inc,

Aventura, Florida, United States

West Boca Dialysis Center

Boca Raton, Florida, United States

Florida Kidney Center

Lauderhill, Florida, United States

South Florida Research Institute

Laureda Lake, Florida, United States

Coconut Creek Dialysis JV

Margate, Florida, United States

American Renal Associates Naples Dialysis Center

Naples, Florida, 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

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

Ft. Lauderdale Kidney Center

Plantation, Florida, United States

Plantation Kidney Center

Plantation, Florida, United States

Tamarac Kidney Center

Tamarac, Florida, United States

Dialysis of Dublin

Dublin, Georgia, United States

Renal Physicians of Georgia, PC

Dublin, Georgia, United States

Liberty Dialysis/Boise Kidney & Hypertension Institute

Caldwell, Idaho, United States

Liberty Dialysis/Boise Kidney & Hypertension Institute

Meridian, Idaho, United States

Pacific Renal Research Institute/Boise Kidney & Hypertension Institute

Meridian, Idaho, United States

Liberty Dialysis/Boise Kidney & Hypertension Institute

Nampa, Idaho, United States

Neomedica South

Chicago, Illinois, United States

FMC Ross Englewood Dialysis

Chicago, Illinois, United States

Neomedica Evergreen Park

Evergreen Park, Illinois, United States

Research by Design, LLC

Evergreen Park, Illinois, United States

North Suburban Nephrology, LLC

Gurnee, Illinois, United States

Neomedica Round Lake

Round Lake, Illinois, United States

Clinton Township Dialysis

Clinton Township, Michigan, United States

Grosse Pointe Dialysis

Detroit, Michigan, United States

Renaissance Renal Research Institute, LLC

Detroit, Michigan, United States

Biloxi Dialysis

Biloxi, Mississippi, United States

FMC/South Mississippi Kidney Center of Gulfport

Gulfport, Mississippi, United States

South Mississippi Medical Research, PLLC

Gulfport, Mississippi, United States

Barnes-Jewish Dialysis Center

St Louis, Missouri, United States

Chromalloy American Kidney Center Washington University School of Medicine

St Louis, Missouri, United States

Lower Manhattan Dialysis Center II

New York, New York, United States

Mountain Kidney and Hypertension Associates, P A

Asheville, North Carolina, United States

Asheville Kidney Center

Asheville, North Carolina, United States

ECU Nephrology and Hypertension

Greenville, North Carolina, United States

East Carolina University

Greenville, North Carolina, United States

Cincinnati VA Medical Center

Cincinnati, Ohio, United States

Fresenius Greater Columbus Regional Dialysis Center

Columbus, Ohio, United States

HNC Dialysis, Ltd.

Columbus, Ohio, United States

Delaware Valley Nephrology and Hypertension Associates, PC

Philadelphia, Pennsylvania, United States

Fresenius Medical Care- Mt. Airy Kidney Center

Philadelphia, Pennsylvania, United States

Fresenius Medical Care - Olney Dialysis Center

Philadelphia, Pennsylvania, 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

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 South Columbia JV

Columbia, South Carolina, United States

Fresenius Medical Care SE Columbia JV

Columbia, South Carolina, United States

Sumter Dialysis Clinic

Sumter, South Carolina, United States

Gamma Medical Research Inc.

Edinburg, Texas, United States

Med Center Dialysis

Houston, Texas, United States

Fresenius Medical Care Kidney Center

Houston, Texas, United States

Meyerland Dialysis

Houston, Texas, United States

Millennium Clinical Research, Inc.

Houston, Texas, United States

Southwest Houston Dialysis

Houston, Texas, United States

DaVita North Park

Houston, Texas, United States

North Shepherd Dialysis Center

Houston, Texas, United States

Southwest Houston Research, Ltd.

Houston, Texas, United States

Dialysis Center of Lubbock

Lubbock, Texas, United States

Fresenius Medical Care McAllen

McAllen, Texas, United States

Fresenius Medial Care Mission

Mission, Texas, United States

Missouri City Dialysis

Missouri City, 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

Floyd Curl DaVita Dialysis Center

San Antonio, Texas, United States

Butler Farm Dialysis

Hampton, Virginia, United States

Peninsula Kidney Associates

Hampton, Virginia, United States

Consolidated Medical Plaza

Caguas, , Puerto Rico

Fresenius Medical Care·Humacao

Humacao, , Puerto Rico

Countries

United States; Puerto Rico

References

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.

Reference Type: DERIVED

PMID: 32734207 (View on PubMed)

Other Identifiers

C3461004

Identifier Type: OTHER

Identifier Source: secondary_id

EPOE-11-03

Identifier Type: -

Identifier Source: org_study_id