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Chronic Kidney DiseasePhase 3AiME - 01NCT01473407

A Phase 3 Study Comparing the Effects of Intravenous 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 Phase 3 study testing Epoetin Hospira and Epogen (Amgen) in people with Chronic Kidney Disease and Chronic Renal Failure, run by Pfizer at 85 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Chronic Kidney Disease, Chronic Renal Failure
What is being tested?
Epoetin Hospira and Epogen (Amgen)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
612 participants
Where
85 sitesin 2 countries
Study dates
31 Jan 2012to 11 Feb 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient is able to provide written informed consent after risks and benefits of the study have been explained prior to any study related activities
  • Hemodialysis patients with chronic renal failure and renal anemia currently on stable Epogen (Amgen) treatment for at least 4 weeks prior to randomization, for whom the following apply (during this period):
  • Epogen (Amgen) dose has been administered intravenously 1 to 3 times per week with no more than a 10% dose change from the mean for at least 4 weeks prior to randomization
  • Stable hemoglobin, defined as meeting all of the following:
  • Mean hemoglobin during the 4 weeks prior to randomization between 9.0 and 11.0 g/dL
  • No more than one hemoglobin outside of range from 9.0-11.0 g/dL during the 4 weeks prior to randomization
Show all 15Show fewer
  • No hemoglobin result more than ±1 g/dL from the mean hemoglobin level during the 4 week period prior to randomization
  • 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
  • Patients with adequate iron stores, defined as ferritin >100 μg/L and TSAT >20%, prior to randomization
  • Male or female patients aged 18 to 80 years (both inclusive)
  • If female, patient must be either postmenopausal for at least 1 year prior to randomization, 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 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

Who cannot join

  • Maintenance Epoetin dosage >600 U/kg per week (1-3 times per week)
  • Treatment with long-acting epoetin analogues such as Aranesp ® within 3 months prior to randomization
  • 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
Show all 34Show fewer
  • 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)
  • 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
  • Known, clinically manifested deficiency of folic acid and/or vitamin B12 (irrespective of whether currently treated or not)
  • A patient with any active, uncontrolled systemic, inflammatory or malignant disease (including demyelinating diseases such as multiple sclerosis) that in the Investigator's opinion may be significant to exclude participation in the study, including but not limited to microbial, viral, or fungal infection or mental disease
  • Contraindication for the test drug or have been previously treated with Epoetin Hospira
  • Relative or absolute iron deficiency prior to randomization
  • Platelet count below 100 x 10^9/L
  • Clinically relevant increase of CRP (>10 mg/dL) for at least 2 weeks
  • 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
  • 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)
  • A female patient who is pregnant, lactating or planning a pregnancy during the study
  • History of drug abuse or alcohol abuse within 2 years prior to randomization as determined by the Investigator
  • Current participation or participation in a drug or other investigational research study within 30 days prior to randomization
  • 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
  • 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
  • A patient who in the Investigator's opinion, has any clinically significant abnormal laboratory evaluations, including liver function taken at Screening Visit
  • Positive laboratory test for human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg)

Trial locations and contacts

85 sites in 2 countries.

85 sites in 2 countries

United States84 sites

  • Lakhi M. Sakhrani, MD A Medical Coporation

    Alhambra, California, 91801

  • Nephrology and Internal Medicine of Anderson

    Anderson, South Carolina, 29621

  • South Arlington Dialysis Center

    Arlington, Texas, 76015

  • Mountain Kidney and Hypertension Associates, PA

    Asheville, North Carolina, 28801

  • North America Research Institute

    Azusa, California, 91702

  • DaVita Dialysis Center-Bakersfield Dialysis Center

    Bakersfield, California, 93309

  • Brookdale Physician Dialysis Associates

    Brooklyn, New York, 11212

  • Southeast Renal Research Institute

    Chattanooga, Tennessee, 37404

  • Cincinnati VA Medical Center

    Cincinnati, Ohio, 45220

  • DaVita Dialysis Centers

    Clinton Township, Michigan, 48038

  • Columbia Nephrology Associates, P.A.

    Columbia, South Carolina, 29203

  • Columbia Nephrology Associates, PA

    Columbia, South Carolina, 29203

  • HNC Dialysis Ltd.

    Columbus, Ohio, 43215

  • South Florida Nephrology, Inc.

    Coral Springs, Florida, 33071

  • St. Clair Specialty Physicians, P.C.

    Detroit, Michigan, 48236

  • Renal Physicians of Georgia, PC

    Dublin, Georgia, 31021

  • Hypertension & Nephrology Associates

    Eatontown, New Jersey, 07724

  • Bayview Nephrology, Inc

    Erie, Pennsylvania, 16507

  • DaVita-Erie Dialysis Center

    Erie, Pennsylvania, 16507

  • UPMC Hamot Clinical Trials Department

    Erie, Pennsylvania, 16507

  • Research by Design, LLC

    Evergreen Park, Illinois, 60805

  • Clinical Research and Consulting Center, LLC

    Fairfax, Virginia, 22030

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

    Fairfield, California, 94533

  • A Medical Corporation

    Glendale, California, 91204

  • Renal Consultants Medical Group

    Granada Hills, California, 91344

  • East Carolina University, ECU School of Medicine, Department of Internal Medicine

    Greenville, North Carolina, 27834

  • Texas Renal Care

    Greenville, Texas, 75402

  • South Mississippi Medical Research, PLLC

    Gulfport, Mississippi, 39501

  • North Suburban Nephrology, LLC

    Gurnee, Illinois, 60031

  • Peninsula Kidney Associates

    Hampton, Virginia, 23666

  • Med Center Dialysis

    Houston, Texas, 77004

  • Meyerland Dialysis

    Houston, Texas, 77035

  • Millenium Clinical Research, Inc.

    Houston, Texas, 77054-11801

  • Millennium Clinical Research, Inc.

    Houston, Texas, 77054-11801

  • Research Across America

    Houston, Texas, 77054

  • Southwest Houston Dialysis

    Houston, Texas, 77071

  • Southwest Houston Research, Ltd.

    Houston, Texas, 77099

  • La Puente Dialysis Center

    La Puente, California, 91744

  • Advanced Medical Research, LLC

    Lakewood, California, 90712

  • Kidney Specialists of Southern Nevada

    Las Vegas, Nevada, 89106

  • South Florida Research Institute

    Lauderdale Lakes, Florida, 33313

  • DaVita Bixby Knolls Dialysis

    Long Beach, California, 90807

  • Bayview Nephrology, Inc

    Long Beach, California, 90813

  • Academic Medical Research Institute

    Los Angeles, California, 90022

  • Texas Tech University Health Sciences Center

    Lubbock, Texas, 79430

  • Westbank Nephrology Associates

    Marrero, Louisiana, 70072

  • Private practice of Roberto Mangoo-Karim MD

    McAllen, Texas, 78503

  • Boise Kidney & Hypertension Institute, PLLC

    Meridian, Idaho, 83642

  • Nephrology Specialists, PC

    Merrillville, Indiana, 46410

  • San Marcus Research Clinic, Inc

    Miami, Florida, 33015

  • Nephrology Associates of South Miami

    Miami, Florida, 33173

  • Nephrology and Hypertension Associates

    Middlebury, Connecticut, 06762

  • Missouri City Dialysis

    Missouri City, Texas, 77489

  • Desert Nephrology Medical Group

    Modesto, California, 95350

  • Montgomery Kidney Specialists

    Montgomery, Alabama, 36106

  • ARA Naples South Dialysis Center

    Naples, Florida, 34112-6703

  • ARA- Naples Dialysis Center, LLC

    Naples, Florida, 34119

  • La Jolla Clinical Research, Inc.

    National City, California, 91950

  • Eastern Nephrology Associates, PLLC

    New Bern, North Carolina, 28562

  • Internal Medicine Specialists

    New Orleans, Louisiana, 70115

  • Lower Manhattan Dialysis Center

    New York, New York, 10016

  • Internal Medicine Kidney and Hypertension Center

    Norfolk, Virginia, 23502

  • Innovative Medical Research of South Florida, Inc.

    North Miami Beah, Florida, 33169

  • Valley Renal Medical Group

    Northridge, California, 91324

  • Discovery Medical Research Group, Inc.

    Ocala, Florida, 34471

  • Ontario Dialysis Inc

    Ontario, California, 91762

  • Palmetto Nephrology, PA

    Orangeburg, South Carolina, 29118

  • South Carolina Nephrology and Hypertension Center, Inc.

    Orangeburg, South Carolina, 29118

  • Central Florida Kidney Centers

    Orlando, Florida, 32801-3621

  • Franklin Dialysis Center

    Philadelphia, Pennsylvania, 19106

  • Delaware Valley Nephrology and Hypertension Associates, PC

    Philadelphia, Pennsylvania, 19118

  • Discovery medical Research Group, Inc.

    Porterville, California, 93257

  • San Antonio Kidney Disease Center Physicians Group, P.L.L.C.

    San Antonio, Texas, 78229

  • DaVita Dialysis Center-Floyd Curl Dialysis

    San Antonio, Texas, 78240

  • Northwest Louisiana Nephrology

    Shreveport, Louisiana, 71101

  • Chromalloy American Kidney Center

    St Louis, Missouri, 63110

  • Desert Nephrology Medical Group

    Sumter, South Carolina, 29150

  • Nephrology Educational Services and Research, Inc

    Tarzana, California, 91356

  • Southwest Clinical Research Institute, LLC

    Tempe, Arizona, 85284

  • Queen Dialysis Center

    West Covina, California, 91790

  • American Institute of Research

    Whittier, California, 90603

  • Mark C. Lee, Inc. Santa Fe Springs Dialysis

    Whittier, California, 90606

  • Brookview Hills Research Associates, LLC

    Winston-Salem, North Carolina, 27103

  • North Valley Nephrology

    Yuba City, California, 95991

Other trials in United States

Puerto Rico1 site

  • Consolidated Medical Plaza

    Caguas, 00725

Other trials in Puerto Rico

About this study

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

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

Being tested
Epoetin Hospira, Epogen (Amgen)
Medical subject headings
Renal Insufficiency, Chronic, Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Epoetin HospiraBiological

    Variable dose

  • Epogen (Amgen)Biological

    Also called Epoetin Alfa

    Variable dose

Study groups in NCT01473407
Study groupRoleWhat they receive
Epoetin HospiraExperimentalEpoetin Hospira
Receives: Biological: Epoetin Hospira
Epogen (Amgen)Active comparatorEpogen (Amgen)
Receives: Biological: Epogen (Amgen)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Weekly Hemoglobin Level From Week 21 to Week 24

    Measured: Week 21 up to Week 24

  2. Mean Weekly Dosage of Study Medication From Week 21 to Week 24

    Measured: Week 21 up to Week 24

Secondary outcomes (11)

  1. Mean Weekly Hemoglobin Level Through 24 Weeks

    Measured: Week 1 up to Week 24

  2. Mean Weekly Dosage of Study Medication Through 24 Weeks

    Measured: Week 1 up to Week 24

  3. Total Dose of Study Medication Administered

    Measured: Week 1 up to Week 24

  4. Percentage of Participants With Mean Weekly Hemoglobin Level Within the Target Range

    Percentage of participants who had hemoglobin level within the target range of 9 to 11 g/dL for the specified weeks were reported.

    Measured: Week 12, 24

  5. Percentage of Participants Who Required Permanent Dose Changes of Study Medication

    Measured: Week 1 up to Week 24

  6. Percentage of Participants Who Required Temporary Dose Changes of Study Medication

    Measured: Week 1 up to Week 24

  7. Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 1 Gram Per Deciliter (g/dL)

    Measured: Week 1 up to Week 24

  8. Percentage of Participants With Mean Weekly Hemoglobin Level Outside the Target Range

    Percentage of participants who had hemoglobin level outside the target range of 9 to 11 g/dL for the specified weeks were reported.

    Measured: Week 12, 24

  9. Percentage of Participants Who Received Blood Transfusions

    Measured: Week 1 up to Week 24

  10. Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level

    In this outcome measure number of participants with change (increase and decrease) in mean dose of Epoetin Hospira and Epogen were categorized and reported according to their mean hemoglobin levels. Hemoglobin levels were divided in following classes: >11.0 g/dL, from 9.0 to 11.0 g/dL and <9.0 g/dL

    Measured: Week 1 up to Week 24

  11. Percentage of Participants With Any Transient Change of Hemoglobin Greater Than (>) 2.0 Gram Per Deciliter (g/dL) in Hemoglobin Level

    Measured: Week 1 up to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2011 (estimated)
  2. Study start31 Jan 2012
  3. Primary completion11 Feb 2014
  4. Study completion11 Feb 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
612 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01473407
Sponsor's protocol ID
EPOE-10-01
Other IDs
C3461001
Acronym
AiME - 01
Status last verified
Aug 2018
First submitted
2 Nov 2011
Last updated
10 Sep 2018
Data monitoring committee
No

Publications

  • Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.

    PubMed 36791280

  • 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.

    PubMed 32734207

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Epoetin Hospira and Epogen (Amgen) in people with Chronic Kidney Disease and Chronic Renal Failure, run by Pfizer at 85 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Weekly Hemoglobin Level From Week 21 to Week 24 (time frame: Week 21 up to Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01473407, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2018.

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