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Chronic Renal FailurePhase 3AiME - 13NCT01473420

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 Phase 3 study testing Epoetin Hospira and Epogen Amgen in people with Chronic Renal Failure and Chronic Kidney Disease, run by Pfizer at 73 sites in United States.

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 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Chronic Renal Failure, Chronic Kidney Disease
What is being tested?
Epoetin Hospira and Epogen Amgen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
320 participants
Where
73 sitesUnited States
Study dates
17 Jan 2012to 28 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) 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
Show all 14Show fewer
  • 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 plasma 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 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

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 12 weeks 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 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
  • Contraindication for the test drug or have been previously treated with Epoetin Hospira
  • Relative or absolute iron deficiency prior to randomization into the Maintenance Period
  • 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

73 sites in 1 country.

73 sites in 1 country

United States73 sites

  • CSRA Renal Services, LLC

    Aiken, South Carolina, 29801

  • Dialysis Clinic, Inc. - Albany

    Albany, Georgia, 31701-2057

  • Renal Care Partners of Pentagon City

    Arlington, Virginia, 22206

  • Western Nephrology and Metabolic Bone Disease, PC

    Arvada, Colorado, 80002

  • Newtown Dialysis Center

    Astoria, New York, 11102

  • Kidney Care Associates

    Augusta, Georgia, 30909

  • Fresenius Medical Care - Austin North Dialysis

    Austin, Texas, 78758

  • Research Management, Inc.

    Austin, Texas, 78758

  • Research Management, Inc

    Austin, Texas, 78758

  • North America Research Institute

    Azusa, California, 91702

  • National Institute of Clinical Research

    Bakersfield, California, 93309

  • Neomedica Marquette Park

    Chicago, Illinois, 60636

  • University of Cincinnati College of Medicine

    Cincinnati, Ohio, 45267

  • Fresenius Medical Care Midtown JV

    Columbia, South Carolina, 29201

  • Columbia Nephrology Associates, PA

    Columbia, South Carolina, 29203

  • Dallas Veterans Affairs Medical Center

    Dallas, Texas, 75216

  • Renal Physicians of Georgia, PC

    Dublin, Georgia, 31021

  • Research by Design, LLC

    Evergreen Park, Illinois, 60805

  • Clinical Research and Consulting Center, LLC

    Fairfax, Virginia, 22030

  • Renal Care Partners of Fairfax

    Fairfax, Virginia, 22030

  • New York Hospital Medical Center Queens Institutional Review Board

    Flushing, New York, 11355

  • Grand Prairie Dialysis Center

    Grand Prairie, Texas, 75051

  • Research Across America

    Houston, Texas, 77054

  • Westminster Dialysis

    Houston, Texas, 77077

  • Mission Bend Dialysis

    Houston, Texas, 77083

  • Southwest Houston Research, Ltd.

    Houston, Texas, 77099

  • Fresenius Medical Care Irmo JV

    Irmo, South Carolina, 29063

  • Fresenius Medical Care-Kalamazoo East

    Kalamazoo, Michigan, 49001

  • Fresenius Medical Care-Kalamazoo

    Kalamazoo, Michigan, 49007

  • Nephrology Center DBA Paragon Health PC

    Kalamazoo, Michigan, 49007

  • Fresenius Medical Care-Oshtemo

    Kalamazoo, Michigan, 49009

  • Fresenius Medical Care-Gull Road

    Kalamazoo, Michigan, 49048

  • Clinical Research Consultants, LLC

    Kansas City, Missouri, 64111

  • Kansas City Renal Center

    Kansas City, Missouri, 64111

  • Renal Advantage, Inc.

    Kansas City, Missouri, 64131

  • Knoxville Kidney Center, PLLC

    Knoxville, Tennessee, 37923

  • Research Nurse Specialists, LLC

    Lafayette, Louisiana, 70503

  • New York Harbor Health Care System

    Lafayette, Louisiana, 70506

  • Long Beach Dialysis Center

    Long Beach, California, 90813

  • Academic Medical Research Institute

    Los Angeles, California, 90022

  • East Texas Nephrology Associates

    Lufkin, Texas, 75904

  • Westbank Nephrology Associates

    Marrero, Louisiana, 70072

  • Northwest Physicians Associates, PC

    Meadville, Pennsylvania, 16335

  • Nephrology Specialists, PC

    Mechanicsville, Virginia, 23116

  • Long Beach Dialysis Center

    Modesto, California, 95350

  • Parker Jewish Institute for Health Care and Rehabilitation

    New Hyde Park, New York, 11040

  • New York Harbor Health Care System

    New York, New York, 10010

  • University of Cincinnati College of Medicine.

    North Brunswick, New Jersey, 08902

  • Innovative Dialysis Center of Northridge, LLC

    Northridge, California, 91324

  • Valley Renal Medical Group

    Northridge, California, 91324

  • Western Institutional Review Board

    Olympia, Washington, 98502

  • FMC Opelousas

    Opelousas, Louisiana, 70570

  • South Carolina Nephrology and Hypertension Center, Inc.

    Orangeburg, South Carolina, 29118

  • Research Management Inc.

    Paramount, California, 90723

  • Pines Clinical Research Inc.

    Pembroke Pines, Florida, 33028

  • Pleasanton Dialysis Center

    Pleasanton, California, 94588

  • Wake Nephrology Associates, PA

    Raleigh, North Carolina, 27609

  • Sunset Dialysis Center

    Rancho Cordova, California, 95670

  • Capital Nephrology Medical Group

    Sacramento, California, 95825

  • San Antonio Kidney Disease Center

    San Antonio, Texas, 78229

  • Chabot Nephrology Medical Group

    San Leandro, California, 94578

  • San Leandro Dialysis

    San Leandro, California, 94578

  • Renal Consultants Medical Group

    Santa Clarita, California, 91387

  • Northwest Louisiana Nephrology

    Shreveport, Louisiana, 71101

  • Metro Hypertension and Kidney Center

    St Louis, Missouri, 63136

  • Private Practice of Kenneth Lempert

    Toledo, Ohio, 43606

  • Nephrology & Hypertension Associates of NJ

    Voorhees Township, New Jersey, 08043

  • Kidney Center of Westminster, LLC

    Westminster, Colorado, 80031

  • Western Nephrology and Metabolic Bone Disease, PC

    Westminster, Colorado, 80031

  • Intercommunity Dialysis Center

    Whittier, California, 90602

  • American Institute of Research

    Whittier, California, 90603

  • Whittier Kidney Dialysis Center

    Whittier, California, 90603

  • Kansas Nephrology Physicians, PA

    Wichita, Kansas, 67214

Other trials in United States

About this study

Official title: 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

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.

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

    Also called Epoetin Alfa

    Variable dose

Study groups in NCT01473420
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 30 to Week 34: Maintenance Period

    Measured: Week 30 up to Week 34

  2. Mean Weekly Dosage of Study Medication From Week 30 to Week 34: Maintenance Period

    Measured: Week 30 up to Week 34

Secondary outcomes (12)

  1. Mean Weekly Hemoglobin Level From Week 19 to Week 34: Maintenance Period

    Measured: Week 19 up to Week 34

  2. Mean Weekly Dosage of Study Medication From Week 19 to Week 34: Maintenance Period

    Measured: Week 19 up to Week 34

  3. Total Dose of Study Medication Administered: Maintenance Period

    In this outcome measure mean of total dose of study medication administered in maintenance period was reported.

    Measured: Week 19 up to Week 34

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

    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 26, 34

  5. Percentage of Participants Who Required Permanent Dose Changes: Maintenance Period

    Measured: Week 19 up to Week 34

  6. Percentage of Participants Who Required Temporary Dose Changes: Maintenance Period

    Measured: Week 19 up to Week 34

  7. Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 1.0 Gram Per Deciliter (g/dL): Maintenance Period

    Measured: Week 19 up to Week 34

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

    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 26, 34

  9. Percentage of Participants Who Qualified as Optimally Titrated and Stable: Titration Period

    Measured: Week 1 up to Week 18

  10. Percentage of Participants Who Received Blood Transfusions: Maintenance Period

    Measured: Week 19 up to Week 34

  11. Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level: Maintenance Period

    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 19 up to Week 34

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

    Measured: Week 19 up to Week 34

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 start17 Jan 2012
  3. Primary completion28 Feb 2014
  4. Study completion28 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
320 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01473420
Sponsor's protocol ID
EPOE-10-13
Other IDs
C3461003
Acronym
AiME - 13
Status last verified
Jul 2018
First submitted
2 Nov 2011
Last updated
9 Aug 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 Renal Failure and Chronic Kidney Disease, run by Pfizer at 73 sites in United States.

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 14 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 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in United States. 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 20 Jun 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 30 to Week 34: Maintenance Period (time frame: Week 30 up to Week 34). 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 NCT01473420, 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 9 Aug 2018.

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