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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Therapeutic-equivalence Study Comparing The Efficacy And Safety Of Subcutaneous Epoetin Hospira And Epoetin Alfa (Amgen) In Patients With Chronic Renal Failure Requiring Hemodialysis And Receiving Epoetin Maintenance Treatment

NCT01473420•Pfizer

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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:
+4 more criteria

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
+24 more criteria

Locations (73)

North America Research Institute

Azusa, California, United States

National Institute of Clinical Research

Bakersfield, California, United States

Long Beach Dialysis Center

Long Beach, California, United States

Academic Medical Research Institute

Los Angeles, California, United States

Long Beach Dialysis Center

Modesto, California, United States

Innovative Dialysis Center of Northridge, LLC

Northridge, California, United States

Valley Renal Medical Group

Northridge, California, United States

Research Management Inc.

Paramount, California, United States

Pleasanton Dialysis Center

Pleasanton, California, United States

Sunset Dialysis Center

Rancho Cordova, California, United States

Key Dates

Start Date

January 17, 2012

Primary Completion Date

February 28, 2014

Completion Date

February 28, 2014

Last Updated

August 9, 2018

Enrollment

320

ACTUAL participants

Conditions

Chronic Renal FailureChronic Kidney Disease

Interventions

Epoetin Hospira

BIOLOGICAL

Epogen Amgen

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 9, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease

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