Chronic Renal FailurePhase 3EMERALD 1NCT00597753

Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis

A Phase 3 study testing peginesatide and Epoetin Alfa in people with Chronic Renal Failure and Chronic Kidney Disease, run by Affymax at 89 sites in United States.

Completed

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

Official record

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Trial summary

The purpose of the study was to evaluate the safety and efficacy of peginesatide in the maintenance treatment of anemia in participants on dialysis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Renal Failure, Chronic Kidney Disease, Anemia
What is being tested?: peginesatide and Epoetin Alfa
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 803 participants
Where: 89 sitesUnited States
Study dates: Sep 2007to Jan 2010
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants with chronic renal failure on hemodialysis for ≥ 3 months prior to randomization.
On intravenous epoetin alfa maintenance therapy continuously prescribed for a minimum of 8 weeks prior to randomization.
Four consecutive hemoglobin values with a mean ≥ 10.0 and ≤ 12.0 g/dL during the screening period

Who cannot join

Females who are pregnant or breast-feeding.
Known intolerance to any erythropoiesis stimulating agent (ESA) or pegylated molecule or to all parenteral iron supplementation products.
Known bleeding or coagulation disorder.
Known hematologic disease or cause of anemia other than renal disease
Poorly controlled hypertension
Evidence of active malignancy within one year prior to randomization.

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Temporary (untunneled) dialysis access catheter.
A scheduled kidney transplant
A scheduled surgery that may be expected to lead to significant blood loss.

Trial locations and contacts

89 sites in 1 country.

City, postcode or hospital

89 sites in 1 country

United States89 sites

Research Facility
Alexandria, Virginia, 22304
Research Facility
Allentown, Pennsylvania, 18103
Research Facility
Appleton, Wisconsin, 54956
Research Facility
Arlington, Texas, 76011
Research Facility
Augusta, Georgia, 30901
Research Facility
Augusta, Georgia, 30912
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Baton Rouge, Louisiana, 70809
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Bethesda, Maryland, 20817
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Boise, Idaho, 83706
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Brooklyn, New York, 11212
Research Facility
Canton, Ohio, 44718
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Chesapeake, Virginia, 23320
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Chicago, Illinois, 60661
Research Facility
Cincinnati, Ohio, 45267
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Columbus, Mississippi, 39705
Research Facility
Columbus, Ohio, 43210
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Dearborn, Michigan, 48195
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Decatur, Georgia, 30030
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Denver, Colorado, 80230
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Durham, North Carolina, 27704
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Dyersburg, Tennessee, 38024
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Eatontown, New Jersey, 07724
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Evansville, Indiana, 47714
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Evergreen Park, Illinois, 60805
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Fairfax, Virginia, 22030
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Fairfield, California, 94533
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Fall River, Massachusetts, 02720
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Fort Worth, Texas, 76105
Research Facility
Fort Worth, Texas, 76106
Research Facility
Fort Worth, Texas, 76133
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Granada Hills, California, 91344
Research Facility
Grand Prairie, Texas, 75050
Research Facilities (2)
Greenville, South Carolina, 29605
Research Facility
Gurnee, Illinois, 60031
Research Facility
Honolulu, Hawaii, 96817
Research Facilities (2)
Houston, Texas, 77054
Research Facility
Houston, Texas, 77091
Research Facility
Hudson, Florida, 34667
Research Facility
Kalamazoo, Michigan, 49007
Research Facility
Knoxville, Tennessee, 37923
Research Facility
Lafayette, Louisiana, 70506
Research Facility
Las Vegas, Nevada, 89106
Research Facility
Lexington, Kentucky, 40513
Research Facility
Los Alamitos, California, 90720
Research Facility
Los Angeles, California, 90022
Research Facility
Los Angeles, California, 90033
Research Facility
Los Angeles, California, 90095
Research Facility
Lynwood, California, 90262
Research Facility
Marietta, Georgia, 30060
Research Facility
McAllen, Texas, 78503
Research Facility
Mechanicsville, Virginia, 23116
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Middlebury, Connecticut, 06762
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Monterey Park, California, 91754
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Morgantown, West Virginia, 26506
Research Facility
Mountain View, California, 94041
Research Facility
Nashville, Tennessee, 37205
Research Facility
New Orleans, Louisiana, 70112
Research Facility
New York, New York, 10128
Research Facilities (2)
Norfolk, Virginia, 23507
Research Facility
Ocala, Florida, 34471
Research Facility
Orlando, Florida, 32804
Research Facility
Orlando, Florida, 32806
Research Facility
Oshkosh, Wisconsin, 54904
Research Facility
Paragould, Arkansas, 72450
Research Facility
Paramount, California, 90723
Research Facility
Pembroke Pines, Florida, 33028
Research Facility
Peoria, Illinois, 61603
Research Facility
Philadelphia, Pennsylvania, 19106
Research Facility
Philadelphia, Pennsylvania, 19144
Research Facility
Pittsburgh, Pennsylvania, 15224
Research Facility
Raleigh, North Carolina, 27609
Research Facility
Rockville, Maryland, 20852
Research Facility
Roseburg, Oregon, 97471
Research Facility
San Antonio, Texas, 78205
Research Facility
San Antonio, Texas, 78229
Research Facilities (2)
San Diego, California, 92123
Research Facility
San Dimas, California, 91773
Research Facility
Shreveport, Louisiana, 71101
Research Facility
St Louis, Missouri, 63110
Research Facility
Sumter, South Carolina, 29150
Research Facility
The Bronx, New York, 10461
Research Facility
The Bronx, New York, 10467
Research Facility
Tupelo, Mississippi, 38801
Research Facility
Tyler, Texas, 75701
Research Facility
Whittier, California, 90603
Research Facility
Wichita, Kansas, 67214
Research Facility
Williamsville, New York, 14221
Research Facility
Worcester, Massachusetts, 01605
Research Facility
Yonkers, New York, 10710

Other trials in United States

About this study

Official title: AFX01-12: A Phase 3, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Peginesatide for the Maintenance Treatment of Anemia in Hemodialysis Patients Previously Treated With Epoetin Alfa

The purpose of the study was to evaluate the safety and efficacy of peginesatide in the maintenance treatment of anemia in participants on dialysis.

Read the detailed description

Anemia associated with chronic kidney disease is due to several factors, primarily the inability of the diseased kidneys to produce adequate amounts of endogenous erythropoietin. Ancillary factors include the shortened lifespan of red blood cells, iron and other nutritional deficiencies, infection, and inflammation. The presence and severity of anemia are related to the duration and extent of kidney failure. Anemia is associated with increased mortality, increased likelihood of hospitalization, reduced cognitive function, and increased left ventricular hypertrophy and heart failure.

Erythropoiesis stimulating agents (ESAs) have been established as a treatment for anemia in chronic renal failure subjects, and have improved the management of anemia over alternatives such as transfusion. Peginesatide is a parenteral formulation developed for the treatment of anemia in patients with chronic kidney disease. Peginesatide binds to and activates the human erythropoietin receptor, and stimulates erythropoiesis in human red cell precursors in a manner similar to other known erythropoiesis-stimulating agents.

Eligible participants were randomized in a 2:1 ratio to peginesatide administered once every 4 weeks or to continued treatment with epoetin alfa administered 1-3 times each week, respectively. Total commitment time for this study was 4 weeks of screening followed by a minimum of 52 weeks of study treatment.

To evaluate the cardiovascular safety of peginesatide, a cardiovascular composite safety endpoint (CSE) was defined for use in prospectively planned analyses which combined cardiovascular safety data from the four Phase 3 peginesatide studies (NCT00598273, NCT00597753, NCT00598442, and NCT00597584). The CSE consisted of six events: death, stroke, myocardial infarction, and serious adverse events of congestive heart failure, unstable angina, and arrhythmia. An independent Event Review Committee (ERC) was used to provide blinded adjudication of potential CSE events.

Conditions: Chronic Renal Failure, Chronic Kidney Disease, Anemia
Being tested: peginesatide, Epoetin Alfa
Keywords: anemia, chronic kidney disease, CKD, chronic renal failure, CRF, dialysis, erythropoietin, EPO, erythropoiesis stimulating agent, ESA, Hematide™, hemodialysis, hemoglobin, Hb, Hgb, Omontys, peginesatide, red blood cell, red blood cell production
Medical subject headings: Kidney Failure, Chronic, Renal Insufficiency, Chronic, Anemia

What participants receive

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

peginesatideDrug
Also called Omontys, Hematide, AF37702 Injection
Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
Epoetin AlfaDrug
Also called Epogen
Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.

Study groups in NCT00597753
Study group	Role	What they receive
Peginesatide	Experimental	Not described Receives: Drug: peginesatide
Epoetin alfa	Active comparator	Not described Receives: Drug: Epoetin Alfa

What is being measured

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

Mean Change in Hemoglobin Between Baseline and the Evaluation Period
The baseline hemoglobin value is defined as the mean of five hemoglobin values: the four most recent hemoglobin values taken prior to the day of randomization and the value obtained on the day of randomization. The mean hemoglobin during the Evaluation Period for each participant is calculated as the mean of the available hemoglobin values during study Weeks 29 through 36.
Measured: Baseline and Weeks 29-36

Secondary outcomes (2)

Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods
Measured: Weeks 0 to 36
Proportion of Participants Whose Mean Hemoglobin Level During the Evaluation Period is Within the Target Range of 10.0 - 12.0 Grams Per Deciliter (g/dL)
Measured: Weeks 29 to 36

Timeline

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

Sep 2007Jan 2010

First posted18 Jan 2008 (estimated)
Study startSep 2007
Primary completionJul 2009
Study completionJan 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: None (open label)
Enrolment: 803 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00597753
Sponsor's protocol ID: AFX01-12
Acronym: EMERALD 1
Status last verified: Feb 2013
First submitted: 10 Jan 2008
Last updated: 12 Feb 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Fishbane S, Schiller B, Locatelli F, Covic AC, Provenzano R, Wiecek A, Levin NW, Kaplan M, Macdougall IC, Francisco C, Mayo MR, Polu KR, Duliege AM, Besarab A; EMERALD Study Groups. Peginesatide in patients with anemia undergoing hemodialysis. N Engl J Med. 2013 Jan 24;368(4):307-19. doi: 10.1056/NEJMoa1203165.
PubMed 23343061
Macdougall IC, Provenzano R, Sharma A, Spinowitz BS, Schmidt RJ, Pergola PE, Zabaneh RI, Tong-Starksen S, Mayo MR, Tang H, Polu KR, Duliege AM, Fishbane S; PEARL Study Groups. Peginesatide for anemia in patients with chronic kidney disease not receiving dialysis. N Engl J Med. 2013 Jan 24;368(4):320-32. doi: 10.1056/NEJMoa1203166.
PubMed 23343062

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Renal Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: AFX01-12: A Phase 3, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Peginesatide for the Maintenance Treatment of Anemia in Hemodialysis Patients Previously Treated With Epoetin Alfa
ClinicalTrials.gov ID: NCT00597753
Acronym / sponsor ID: EMERALD 1 / AFX01-12
Conditions: Chronic Renal Failure, Chronic Kidney Disease, Anemia
Keywords: anemia, chronic kidney disease, CKD, chronic renal failure, CRF, dialysis, erythropoietin, EPO
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 803 participants (actual)
Lead sponsor: AffymaxIndustry (pharma, biotech, devices)
Collaborators: Takeda
Study start: Sep 2007
Primary completion: Jul 2009 (actual)
Study completion: Jan 2010 (actual)
First posted: 18 Jan 2008 (estimated)
Results: Posted 30 Jul 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of the study was to evaluate the safety and efficacy of peginesatide in the maintenance treatment of anemia in participants on dialysis.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Peginesatide	Experimental	Drug: peginesatide
Epoetin alfa	Active comparator	Drug: Epoetin Alfa

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Participants with chronic renal failure on hemodialysis for ≥ 3 months prior to randomization.
On intravenous epoetin alfa maintenance therapy continuously prescribed for a minimum of 8 weeks prior to randomization.
Four consecutive hemoglobin values with a mean ≥ 10.0 and ≤ 12.0 g/dL during the screening period

Key exclusion criteria (9 listed)

Females who are pregnant or breast-feeding.
Known intolerance to any erythropoiesis stimulating agent (ESA) or pegylated molecule or to all parenteral iron supplementation products.
Known bleeding or coagulation disorder.
Known hematologic disease or cause of anemia other than renal disease
Poorly controlled hypertension

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
peginesatideAlso: Omontys, Hematide, AF37702 InjectionParticipants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.	Drug	Peginesatide
Epoetin AlfaAlso: EpogenParticipants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.	Drug	Epoetin alfa

Primary outcome

Mean Change in Hemoglobin Between Baseline and the Evaluation Period
Time frame: Baseline and Weeks 29-36
The baseline hemoglobin value is defined as the mean of five hemoglobin values: the four most recent hemoglobin values taken prior to the day of randomization and the value obtained on the day of randomization. The mean hemoglobin during the Evaluation Period for each participant is calculated as the mean of the available hemoglobin values during study Weeks 29 through 36.

2 secondary outcomes

Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods
Time frame: Weeks 0 to 36
Proportion of Participants Whose Mean Hemoglobin Level During the Evaluation Period is Within the Target Range of 10.0 - 12.0 Grams Per Deciliter (g/dL)
Time frame: Weeks 29 to 36

Results and safety

Results posted to the registry on 30 Jul 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Peginesatide	532	366
Epoetin Alfa	271	202

Primary outcome: Mean Change in Hemoglobin Between Baseline and the Evaluation Period

Time frame: Baseline and Weeks 29-36. Mean (Standard Deviation). Unit: g/dL

Measure	Peginesatide n = 524	Epoetin Alfa n = 269
Baseline [N=524, 269]	11.30 (0.523)	11.32 (0.493)
Evaluation Period [N=445, 248]	11.06 (0.932)	11.25 (0.846)
Change from Baseline [N=445, 248]	-0.24 (0.956)	-0.09 (0.922)

Peginesatide vs Epoetin Alfa: Least Squares Mean Difference: -0.15 (95% CI -0.30 to -0.01), ANOVA

Population analysed: Full Analysis Population: All randomized participants who received at least one dose of study medication

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Peginesatide	304 of 524 (58%)	445 of 524 (84.9%)	Not reported
Epoetin Alfa	168 of 269 (62.5%)	235 of 269 (87.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23343061Fishbane S, Schiller B, Locatelli F, Covic AC, Provenzano R, Wiecek A, Levin NW, Kaplan M, Macdougall IC, Francisco C, Mayo MR, Polu KR, Duliege AM, Besarab A; EMERALD Study Groups. Peginesatide in patients with anemia undergoing hemodialysis. N Engl J Med. 2013 Jan 24;368(4):307-19. doi: 10.1056/NEJMoa1203165.
Derived from this study: PubMed 23343062Macdougall IC, Provenzano R, Sharma A, Spinowitz BS, Schmidt RJ, Pergola PE, Zabaneh RI, Tong-Starksen S, Mayo MR, Tang H, Polu KR, Duliege AM, Fishbane S; PEARL Study Groups. Peginesatide for anemia in patients with chronic kidney disease not receiving dialysis. N Engl J Med. 2013 Jan 24;368(4):320-32. doi: 10.1056/NEJMoa1203166.

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End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Vice President, Clinical Development study director

Affymax

89 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing peginesatide and Epoetin Alfa in people with Chronic Renal Failure and Chronic Kidney Disease, run by Affymax at 89 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 3 inclusion and 9 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 12 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 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 30 Jul 2012). 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 Change in Hemoglobin Between Baseline and the Evaluation Period (time frame: Baseline and Weeks 29-36). 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 NCT00597753, 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 12 Feb 2013.