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Chronic Renal Failure Requiring HemodialysisPhase 3AiME - 03NCT01628107

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

A Phase 3 study testing Epoetin Hospira in people with Chronic Renal Failure Requiring Hemodialysis, run by Pfizer at 110 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 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Epoetin Hospira
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
406 participants
Where
110 sitesin 2 countries
Study dates
16 Jul 2012to 2 Jan 2015
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 the risks and benefits of the study have been explained prior to any study-related activities.
  • 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.
  • 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.
  • Adequate methods of contraception to prevent pregnancy are to be maintained throughout the course of the study in both male and female study subjects.

Who cannot join

  • 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.
  • 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
Show all 18Show fewer
  • 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)
  • 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.
  • 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.
  • A female patient who is pregnant, lactating, or planning a pregnancy during the study.
  • History of drug abuse or alcohol abuse during the core study prior to enrollment as determined by the Investigator.
  • 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).
  • 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.
  • Evidence of human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg).
  • A patient who, in the Investigator's opinion, has any clinically significant abnormal laboratory results that may impact patient safety.

Trial locations and contacts

110 sites in 2 countries.

110 sites in 2 countries

United States108 sites

  • Anderson Dialysis Clinic

    Anderson, South Carolina, 29621

  • AnMed Health

    Anderson, South Carolina, 29621

  • Nephrology and Internal Medicine of Anderson

    Anderson, South Carolina, 29621

  • Mountain Kidney and Hypertension Associates, P A

    Asheville, North Carolina, 28801

  • Asheville Kidney Center

    Asheville, North Carolina, 28805

  • Innovative Medical Research of South Florida, Inc,

    Aventura, Florida, 33180

  • North America Research Institute

    Azusa, California, 91702

  • Bellflower Dialysis Center

    Bellflower, California, 90706

  • Biloxi Dialysis

    Biloxi, Mississippi, 39530

  • West Boca Dialysis Center

    Boca Raton, Florida, 33434

  • Liberty Dialysis/Boise Kidney & Hypertension Institute

    Caldwell, Idaho, 83605

  • Neomedica South

    Chicago, Illinois, 60617

  • FMC Ross Englewood Dialysis

    Chicago, Illinois, 60621

  • Cincinnati VA Medical Center

    Cincinnati, Ohio, 45220

  • Clinton Township Dialysis

    Clinton Township, Michigan, 48038

  • Columbia Nephrology Associates, P. A.

    Columbia, South Carolina, 29203

  • Columbia Nephrology Associates, PA

    Columbia, South Carolina, 29203

  • Fresenius Medical Care Columbia JV

    Columbia, South Carolina, 29203

  • Fresenius Medical Care Meadowlake JV

    Columbia, South Carolina, 29203

  • Fresenius Medical Care South Columbia JV

    Columbia, South Carolina, 29203

  • Fresenius Medical Care SE Columbia JV

    Columbia, South Carolina, 29209

  • Fresenius Greater Columbus Regional Dialysis Center

    Columbus, Ohio, 43215

  • HNC Dialysis, Ltd.

    Columbus, Ohio, 43215

  • National Institute of Clinical Research

    Commerce, California, 90040

  • DaVita Premier Dialysis Center

    Cudahy, California, 90201

  • Grosse Pointe Dialysis

    Detroit, Michigan, 48224

  • Renaissance Renal Research Institute, LLC

    Detroit, Michigan, 48236

  • Dialysis of Dublin

    Dublin, Georgia, 31021

  • Renal Physicians of Georgia, PC

    Dublin, Georgia, 31021

  • Gamma Medical Research Inc.

    Edinburg, Texas, 78539

  • Davita - South Valley Dialysis

    Encino, California, 91316

  • Neomedica Evergreen Park

    Evergreen Park, Illinois, 60805

  • Research by Design, LLC

    Evergreen Park, Illinois, 60805

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

    Fairfield, California, 94533

  • Fairfield Dialysis Center

    Fairfield, California, 94534

  • Renal Consultants Medical Group

    Granada Hills, California, 91344

  • ECU Nephrology and Hypertension

    Greenville, North Carolina, 27834-2847

  • East Carolina University

    Greenville, North Carolina, 27834

  • FMC/South Mississippi Kidney Center of Gulfport

    Gulfport, Mississippi, 39501

  • South Mississippi Medical Research, PLLC

    Gulfport, Mississippi, 39501

  • North Suburban Nephrology, LLC

    Gurnee, Illinois, 60031

  • Butler Farm Dialysis

    Hampton, Virginia, 23666

  • Peninsula Kidney Associates

    Hampton, Virginia, 23666

  • Med Center Dialysis

    Houston, Texas, 77004

  • Fresenius Medical Care Kidney Center

    Houston, Texas, 77030

  • Meyerland Dialysis

    Houston, Texas, 77035

  • Millennium Clinical Research, Inc.

    Houston, Texas, 77054

  • Southwest Houston Dialysis

    Houston, Texas, 77071

  • DaVita North Park

    Houston, Texas, 77073

  • North Shepherd Dialysis Center

    Houston, Texas, 77091

  • Southwest Houston Research, Ltd.

    Houston, Texas, 77099

  • Advanced Medical Research (Administrative)

    Lakewood, California, 90712

  • Florida Kidney Center

    Lauderhill, Florida, 33319

  • South Florida Research Institute

    Laureda Lake, Florida, 33313

  • Long Beach Clinical Trials

    Long Beach, California, 90806

  • Westcoast Dialysis

    Long Beach, California, 90806

  • DaVita Bixby Knolls Dialysis

    Long Beach, California, 90807

  • United Dialysis Center

    Long Beach, California, 90807

  • Long Beach Dialysis

    Long Beach, California, 90813

  • Dialysis Center of Lubbock

    Lubbock, Texas, 79430

  • Imperial Care Dialysis Center

    Lynwood, California, 90262

  • Kidney Research Center

    Lynwood, California, 90262

  • Coconut Creek Dialysis JV

    Margate, Florida, 33063

  • Fresenius Medical Care McAllen

    McAllen, Texas, 78503

  • Liberty Dialysis/Boise Kidney & Hypertension Institute

    Meridian, Idaho, 83642

  • Pacific Renal Research Institute/Boise Kidney & Hypertension Institute

    Meridian, Idaho, 83642

  • Nephrology and Hypertension Associates,PC

    Middlebury, Connecticut, 06762

  • Fresenius Medial Care Mission

    Mission, Texas, 78572

  • Missouri City Dialysis

    Missouri City, Texas, 77489

  • Modesto Kidney Center

    Modesto, California, 95350

  • Novo Research d/b/a Foundation Research

    Modesto, California, 95350

  • Parkway Kindey Center

    Modesto, California, 95350

  • Liberty Dialysis/Boise Kidney & Hypertension Institute

    Nampa, Idaho, 83686

  • American Renal Associates Naples Dialysis Center

    Naples, Florida, 34119

  • Lower Manhattan Dialysis Center II

    New York, New York, 10003

  • Innovative Medical Research of South Florida, Inc.

    North Miami Beach, Florida, 33169

  • Physicians Dialysis of North Beach

    North Miami Beach, Florida, 33169

  • Oakdale Kidney Center

    Oakdale, California, 95361

  • Discovery Medical Research Group, Inc.,

    Ocala, Florida, 34471

  • Discovery Medical Research Group, Inc.

    Ocala, Florida, 34471

  • Ocala Regional Kidney Center, East

    Ocala, Florida, 34471

  • Silver Springs Shores Dialysis Center

    Ocala, Florida, 34472

  • National Institute of Clinical Research

    Ontario, California, 91762

  • Ontario Dialysis Center

    Ontario, California, 91762

  • Paramount Dialysis Center

    Paramount, California, 90723

  • Delaware Valley Nephrology and Hypertension Associates, PC

    Philadelphia, Pennsylvania, 19118

  • Fresenius Medical Care- Mt. Airy Kidney Center

    Philadelphia, Pennsylvania, 19118

  • Fresenius Medical Care - Olney Dialysis Center

    Philadelphia, Pennsylvania, 19138

  • Ft. Lauderdale Kidney Center

    Plantation, Florida, 33312

  • Plantation Kidney Center

    Plantation, Florida, 33324

  • Sierra View Dialysis Center

    Porterville, California, 93257

  • Sierra View District Hospital Dialysis Center

    Porterville, California, 93257

  • Sierra View District Hospital

    Porterville, California, 93257

  • Sierra View Nephrology, Inc.

    Porterville, California, CA

  • Neomedica Round Lake

    Round Lake, Illinois, 60073

  • NW Medical Center DaVita Dialysis

    San Antonio, Texas, 78229

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

    San Antonio, Texas, 78229

  • Floyd Curl DaVita Dialysis Center

    San Antonio, Texas, 78240

  • Barnes-Jewish Dialysis Center

    St Louis, Missouri, 63108

  • Chromalloy American Kidney Center Washington University School of Medicine

    St Louis, Missouri, 63110

  • Sumter Dialysis Clinic

    Sumter, South Carolina, 29150

  • Tamarac Kidney Center

    Tamarac, Florida, 33321

  • Nephrology Educational Services and Research, Inc

    Tarzana, California, 91356

  • Santa Clarita Kidney Center

    Valencia, California, 91355

  • Waterbury Dialysis Center

    Waterbury, Connecticut, 06705

  • Greater Waterbury Dialysis

    Waterbury, Connecticut, 06708

  • American Institute of Research

    Whittier, California, 90603

  • Santa Fe Springs Dialysis

    Whittier, California, 90606

Other trials in United States

Puerto Rico2 sites

  • Consolidated Medical Plaza

    Caguas, 00725

  • Fresenius Medical Care·Humacao

    Humacao, 00791

Other trials in Puerto Rico

About this study

Official title: A Phase III, Open-label, Multicenter, Long-term Safety Study Of Intravenous Epoetin Hospira In Patients With Chronic Renal Failure Requiring Hemodialysis And Receiving Epoetin Maintenance Treatment

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.

Being tested
Epoetin Hospira
Keywords
Chronic renal failure, hemodialysis
Medical subject headings
Kidney Failure, Chronic

What participants receive

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

  • Epoetin HospiraBiological

    Also called ESA, Erythropoetin Stimulating Agent

    Intravenous (IV) injection

Study groups in NCT01628107
Study groupRoleWhat they receive
Epoetin HospiraExperimentalEpoetin 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.
Receives: Biological: Epoetin Hospira

What is being measured

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

  1. Percentage of Participants With Treatment Emergent Adverse Events (AEs): Week 1

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.

    Measured: Up through 7 days after first dose of study drug (Week 1)

  2. Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 12

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.

    Measured: Week 1 up to Week 12

  3. Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 13 to 24

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.

    Measured: Week 13 up to Week 24

  4. Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 25 to 36

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.

    Measured: Week 25 up to Week 36

  5. Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 37 to 48

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.

    Measured: Week 37 up to Week 48

  6. Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 48

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.

    Measured: Week 1 up to Week 48

Secondary outcomes (8)

  1. Mean Weekly Dosage of Epoetin Hospira : Over Week 1 to 48

    Measured: Week 1 up to Week 48

  2. Mean Weekly Dosage of Epoetin Hospira for Interval of 12 Weeks

    Measured: Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48

  3. Mean Hemoglobin Levels: Over Week 1 to 48

    Measured: Week 1 up to Week 48

  4. Mean Hemoglobin Levels for Interval of 12 Weeks

    Measured: Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48

  5. Mean Hematocrit Levels: Over Week 1 to 48

    Hematocrit is defined as the percentage of red blood cells in the blood.

    Measured: Week 1 up to Week 48

  6. Mean Hematocrit Levels for Interval of 12 Weeks

    Hematocrit is defined as the percentage of red blood cells in the blood.

    Measured: Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48

  7. Percentage of Participants With Hemoglobin Level Outside the Target Range

    Percentage of participants with hemoglobin level outside the target range of 9.0 to 11.0 g/dL were reported.

    Measured: Week 1 up to Week 48

  8. Percentage of Participants Who Received Blood Transfusions

    Measured: Week 1 up to Week 48

Timeline

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

  1. First posted26 Jun 2012 (estimated)
  2. Study start16 Jul 2012
  3. Primary completion2 Jan 2015
  4. Study completion2 Jan 2015

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
406 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01628107
Sponsor's protocol ID
EPOE-11-03
Other IDs
C3461004
Acronym
AiME - 03
Status last verified
Jun 2018
First submitted
22 Jun 2012
Last updated
19 Jul 2018
Data monitoring committee
No

Publications

  • 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 in people with Chronic Renal Failure Requiring Hemodialysis, run by Pfizer at 110 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 8 inclusion and 18 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 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 110 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 19 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?

Percentage of Participants With Treatment Emergent Adverse Events (AEs): Week 1 (time frame: Up through 7 days after first dose of study drug (Week 1)). The study lists 6 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 NCT01628107, which also lists 1 linked publication.

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 19 Jul 2018.

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