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Chronic Renal Failure Requiring HemodialysisPhase 3AiME - 04NCT01628120

A Phase 3, Long-Term Safety Study of Subcutaneous 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 115 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

To determine the long term safety in treatment-emergent adverse events (TEAEs) of SC 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
170 participants
Where
115 sitesUnited States
Study dates
31 May 2012to 13 Feb 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 Maintenance Period up to and including Week 16 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

115 sites in 1 country.

115 sites in 1 country

United States115 sites

  • Kidney Center of Arvada

    Arvada, Colorado, 80002

  • Western Nephrology and Metabolic Bone Disease, PC

    Arvada, Colorado, 80002

  • Study site

    Arvada, Colorado, 80002

  • Nephrology Centers of America - Augusta (NCA-A)

    Augusta, Georgia, 30901

  • Study site

    Augusta, Georgia, 30901

  • Nephrology Centers of America (NCA) South Augusta

    Augusta, Georgia, 30906

  • Kidney Care Associates, LLC

    Augusta, Georgia, 30909

  • Fresenius Medical Care-Austin North Dialysis

    Austin, Texas, 78758

  • Research Management Inc.

    Austin, Texas, 78758

  • Research Management, Inc.

    Austin, Texas, 78758

  • Study site

    Austin, Texas, 78758

  • Azusa Dialysis Center

    Azusa, California, 91702

  • Study site

    Azusa, California, 91702

  • Pegasus Dialysis

    Bakersfield, California, 93308

  • National Institute of Clinical Research

    Bakersfield, California, 93309

  • Study site

    Bakersfield, California, 93309

  • Bellflower Dialysis Center

    Bellflower, California, 90706

  • Study site

    Belton, Missouri, 64012

  • Dialysis Clinics, Inc. - Belton

    Belton, Missouri, 66012

  • Fresenius Medical Care - Cedar Park

    Cedar Park, Texas, 78613

  • DCI McMillan

    Cincinnati, Ohio, 45206

  • Study site

    Cincinnati, Ohio, 45267

  • Study site

    College Point, New York, 11356

  • FMC Metro North Dialysis

    Florissant, Missouri, 63033

  • Study site

    Flushing, New York, 11355

  • Trude Weishaupt Memorial Dialysis Center

    Fresh Meadows, New York, 11365

  • Study site

    Granada Hills, California, 91344

  • Grand Prairie Dialysis Center

    Grand Prairie, Texas, 75051

  • Study site

    Grand Prairie, Texas, 75051

  • Grovetown Dialysis Center

    Grovetown, Georgia, 30813

  • Mission Bend Dialysis

    Houston, Texas, 77083

  • Southwest Houston Research, Ltd.

    Houston, Texas, 77099

  • Study site

    Houston, Texas, 77099

  • Fresenius Medical Care- Kalamazoo East

    Kalamazoo, Michigan, 49001

  • Fresenius Medical Care - Kalamazoo

    Kalamazoo, Michigan, 49007

  • Nephrology Center DBA Paragon Health PC

    Kalamazoo, Michigan, 49007

  • Study site

    Kalamazoo, Michigan, 49007

  • Fresenius Medical Care - Oshtermo

    Kalamazoo, Michigan, 49009

  • Fresenius Medical Care- Gull Road

    Kalamazoo, Michigan, 49048

  • Fresenius Medical Care

    Knoxville, Tennessee, 37921

  • Cedar Bluff Dialysis

    Knoxville, Tennessee, 37923

  • Knoxville Kidney Center, PLLC

    Knoxville, Tennessee, 37923

  • Study site

    Knoxville, Tennessee, 37923

  • FMC Northside

    Lafayette, Louisiana, 70501

  • Research Nurse Specialists ,LLC

    Lafayette, Louisiana, 70503

  • Study site

    Lafayette, Louisiana, 70506

  • Lakewood Dialysis Center

    Lakewood, California, 90712

  • Westcoast Dialysis

    Long Beach, California, 90806

  • Long Beach Dialysis

    Long Beach, California, 90813

  • Novo Research

    Long Beach, California, 90813

  • Study site

    Long Beach, California, 90813

  • Academic Medical Research Institute

    Los Angeles, California, 90022

  • East LA Dialysis Center

    Los Angeles, California, 90022

  • Study site

    Los Angeles, California, 90022

  • SNG Dialysis Center of Lufkin

    Lufkin, Texas, 75904

  • Study site

    Lufkin, Texas, 75904

  • East Macon Dialysis

    Macon, Georgia, 31217

  • Renal Physicians of Georgia, PC

    Macon, Georgia, 31217

  • Study site

    Macon, Georgia, 31217

  • meadville Dialysis

    Meadville, Pennsylvania, 16335

  • The Center for Hypertension and Nephrology Care

    Meadville, Pennsylvania, 16335

  • ARA Mechanicsville Dialysis

    Mechanicsville, Virginia, 23116

  • Nephrology Specialists, P.C.

    Mechanicsville, Virginia, 23116

  • Study site

    Mechanicsville, Virginia, 23116

  • Modesto Kidney Center

    Modesto, California, 95350

  • Novo Research, Inc. d/b/a Foundation Research

    Modesto, California, 95350

  • Parkway Kidney Center

    Modesto, California, 95350

  • Study site

    Modesto, California, 95350

  • FMC Normandy Dialysis

    Normandy, Missouri, 63121

  • Dialysis Clinic Incorporated

    North Brunswick, New Jersey, 08902

  • Study site

    North Brunswick, New Jersey, 08902

  • US Renal Care of Northridge

    Northridge, California, 91324

  • Study site

    Northridge, California, 91324

  • Norwalk Dialysis Center

    Norwalk, California, 90650

  • Oakdale Kidney Center

    Oakdale, California, 95361

  • FMC Opelousas

    Opelousas, Louisiana, 70570

  • US Renal Care of Panorama City

    Panorama City, California, 91402

  • Mohammad Ismail MD, Inc.

    Paramount, California, 90723

  • Paramount Dialysis Center

    Paramount, California, 90723

  • Study site

    Paramount, California, 90723

  • Pines Clinical Research, Inc.

    Pembroke Pines, Florida, 33028

  • Study site

    Pembroke Pines, Florida, 33028

  • Perry Dialysis Center

    Perry, Georgia, 31069

  • Wake Dialysis Clinic

    Raleigh, North Carolina, 27609

  • Wake Nephrology Associates, PA

    Raleigh, North Carolina, 27609

  • Study site

    Raleigh, North Carolina, 27609

  • ARA South Laburnum Dialysis

    Richmond, Virginia, 23231

  • FMC St. Louis Regional Dialysis

    Saint Ann, Missouri, 63074

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

    San Antonio, Texas, 78229

  • Las Palmas Davita Dialysis Center

    San Antonio, Texas, 78237

  • Study site

    San Antonio, Texas, 78237

  • Canyon Country Dialysis Center

    Santa Clarita, California, 91387

  • Kennedy Dialysis Center

    Sewell, New Jersey, 08080

  • California Kidney Medical Group

    Simi Valley, California, 93065

  • Metro Hypertension and Kidney Center

    St Louis, Missouri, 63136

  • Study site

    St Louis, Missouri, 63136

  • Innovative Dialysis of Toledo

    Toledo, Ohio, 43606

  • Toledo Hospital, Promedica Health System

    Toledo, Ohio, 43606

  • Study site

    Toledo, Ohio, 43606

  • Alexis Dialysis Center

    Toledo, Ohio, 43613

  • Wildwood Dialysis Center

    Toledo, Ohio, 43615

  • US Renal Care of Van Nuys

    Van Nuys, California, 91405

  • Kennedy Dialysis Center

    Voorhees Township, New Jersey, 08043

  • Study site

    Voorhees Township, New Jersey, 08043

  • Waynesboro Dialysis Center

    Waynesboro, Georgia, 30830

  • Kidney Center of westminster, LLC

    Westminster, Colorado, 80031

  • Western Nephrology and Metabolic Bone Disease, PC

    Westminster, Colorado, 80031

  • Study site

    Westminster, Colorado, 80031

  • intercommunity Dialysis Center

    Whittier, California, 90602

  • American Institute of Research

    Whittier, California, 90603

  • Whittier Kidney Dialysis Center

    Whittier, California, 90603

  • Study site

    Whittier, California, 90603

  • Fresenius Medical Care Midtown #8498

    Wichita, Kansas, 67214

  • Kansas Nephrology Research Institute, LLC

    Wichita, Kansas, 67214

  • Study site

    Wichita, Kansas, 67214

Other trials in United States

About this study

Official title: A Phase 3, Open-label, Multicenter, Long-term Safety Study Of Subcutaneous Epoetin Hospira In Patients With Chronic Renal Failure Requiring Hemodialysis And Receiving Epoetin Maintenance Treatment

To determine the long term safety in treatment-emergent adverse events (TEAEs) of SC 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 Stimulation Agents

    Subcutaneous(SC) injection

Study groups in NCT01628120
Study groupRoleWhat they receive
Epoetin HospiraExperimentalEpoetin Hospira will be administered by SC 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 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 start31 May 2012
  3. Primary completion13 Feb 2015
  4. Study completion13 Feb 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
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01628120
Sponsor's protocol ID
EPOE-11-04
Other IDs
C3461005
Acronym
AiME - 04
Status last verified
Feb 2019
First submitted
22 Jun 2012
Last updated
18 Mar 2019
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 115 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 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 18 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 115 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 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 NCT01628120, 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 18 Mar 2019.

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