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A Phase 3 Study Comparing the...

A Phase 3 Study Comparing the Effects of Subcutaneous Epoetin Hospira and Epoetin Alfa [Epogen] (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin

Last Updated: 2018-08-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-17

Study Completion Date

2014-02-28

Brief Summary

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The purpose of this study is to demonstrate therapeutic equivalence of subcutaneous (SC) Epoetin Hospira compared to SC Epogen (Amgen), based on maintenance of hemoglobin (Hb) levels and study drug dose requirements in patients treated for anemia associated with chronic renal failure and on hemodialysis.

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Detailed Description

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Conditions

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Chronic Renal Failure Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Epoetin Hospira

Group Type EXPERIMENTAL

Epoetin Hospira

Intervention Type BIOLOGICAL

Variable dose

Epogen (Amgen)

Group Type ACTIVE_COMPARATOR

Epogen Amgen

Intervention Type BIOLOGICAL

Variable dose

Interventions

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Epoetin Hospira

Variable dose

Intervention Type BIOLOGICAL

Epogen Amgen

Variable dose

Intervention Type BIOLOGICAL

Other Intervention Names

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Epoetin Alfa

Eligibility Criteria

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Inclusion Criteria

1. Patient is able to provide written informed consent after risks and benefits of the study have been explained prior to any study related activities
2. Hemodialysis patients with chronic renal failure and renal anemia currently on stable Epogen (Amgen) dose administered IV or SC, 1 to 3 times per week for whom the following apply:

* A change in Epogen dosing of no more than 10% from the mean
* Mean hemoglobin between 9.0 and 11.0 g/dL
* No more than one hemoglobin result outside of range from 9.0-11.0 g/dL
* No hemoglobin result more than ±1 g/dL from the mean hemoglobin level
3. Patients on stable, adequate dialysis for at least 12 weeks prior to randomization, defined as no clinically relevant changes of dialysis regimen and/or dialyzer
4. Patients with adequate iron stores, defined as plasma ferritin \> 100 μg/L and TSAT \>20%, prior to randomization
5. Male or female patients aged 18 to 80 years (both inclusive)
6. If female, patient must be postmenopausal for at least one year prior to randomization, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least one of the following methods of birth control:

* hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to randomization
* intrauterine device (IUD)
* 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 randomization. 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 dose

Exclusion Criteria

1. Maintenance epoetin dosage \>600 U/kg per week (1-3 times per week)
2. Treatment with long-acting epoetin analogues such as Aranesp ® within 12 weeks prior to randomization
3. Any of the following within 3 months prior to randomization:

* 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)
4. Uncontrolled hypertension within the 4 weeks prior to randomization defined as more than 10% of post-dialysis blood pressures \>170 mmHg systolic and/or \>110 mmHg diastolic, based on blood pressure readings obtained when the patient's post-dialysis body weight was not more than 0.5 kg above their listed dry weight
5. Known, clinically manifested deficiency of folic acid and/or vitamin B12 (irrespective of whether currently treated or not)
6. A patient with any active, uncontrolled systemic, inflammatory or malignant disease that 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
7. Contraindication for the test drug or have been previously treated with Epoetin Hospira
8. Relative or absolute iron deficiency prior to randomization into the Maintenance Period
9. Platelet count below 100 x 10\^9/L
10. Clinically relevant increase of CRP (\>10 mg/dL) for at least 2 weeks
11. 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 the study participation
12. History of any of the following:

* Detectable anti-rhEPO antibodies
* Clinically relevant malnutrition
* Confirmed aluminum intoxication
* Myelodysplastic syndrome
* Known bone marrow fibrosis (osteitis fibrosa cystica)
* Known seizure disorder
* Liver cirrhosis with clinical evidence of complications (portal hypertension, splenomegaly, ascites)
13. A female patient who is pregnant, lactating or planning a pregnancy during the study
14. History of drug abuse or alcohol abuse within 2 years prior to randomization as determined by the Investigator
15. Current participation or participation in a drug or other investigational research study within 30 days prior to randomization
16. 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
17. Donated or lost \>475 mL (i.e., 1 pint) blood volume (including plasmapheresis) or had a transfusion of any blood product within 3 months prior to randomization
18. A patient who in the Investigator's opinion, has any clinically significant abnormal laboratory evaluations, including liver function taken at Screening Visit
19. Positive laboratory test for human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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North America Research Institute

Azusa, California, United States

Site Status

National Institute of Clinical Research

Bakersfield, California, United States

Site Status

Long Beach Dialysis Center

Long Beach, California, United States

Site Status

Academic Medical Research Institute

Los Angeles, California, United States

Site Status

Long Beach Dialysis Center

Modesto, California, United States

Site Status

Innovative Dialysis Center of Northridge, LLC

Northridge, California, United States

Site Status

Valley Renal Medical Group

Northridge, California, United States

Site Status

Research Management Inc.

Paramount, California, United States

Site Status

Pleasanton Dialysis Center

Pleasanton, California, United States

Site Status

Sunset Dialysis Center

Rancho Cordova, California, United States

Site Status

Capital Nephrology Medical Group

Sacramento, California, United States

Site Status

Chabot Nephrology Medical Group

San Leandro, California, United States

Site Status

San Leandro Dialysis

San Leandro, California, United States

Site Status

Renal Consultants Medical Group

Santa Clarita, California, United States

Site Status

Intercommunity Dialysis Center

Whittier, California, United States

Site Status

American Institute of Research

Whittier, California, United States

Site Status

Whittier Kidney Dialysis Center

Whittier, California, United States

Site Status

Western Nephrology and Metabolic Bone Disease, PC

Arvada, Colorado, United States

Site Status

Kidney Center of Westminster, LLC

Westminster, Colorado, United States

Site Status

Western Nephrology and Metabolic Bone Disease, PC

Westminster, Colorado, United States

Site Status

Pines Clinical Research Inc.

Pembroke Pines, Florida, United States

Site Status

Dialysis Clinic, Inc. - Albany

Albany, Georgia, United States

Site Status

Kidney Care Associates

Augusta, Georgia, United States

Site Status

Renal Physicians of Georgia, PC

Dublin, Georgia, United States

Site Status

Neomedica Marquette Park

Chicago, Illinois, United States

Site Status

Research by Design, LLC

Evergreen Park, Illinois, United States

Site Status

Kansas Nephrology Physicians, PA

Wichita, Kansas, United States

Site Status

Research Nurse Specialists, LLC

Lafayette, Louisiana, United States

Site Status

New York Harbor Health Care System

Lafayette, Louisiana, United States

Site Status

Westbank Nephrology Associates

Marrero, Louisiana, United States

Site Status

FMC Opelousas

Opelousas, Louisiana, United States

Site Status