Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis
EMERALD 1
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
1 other identifier
interventional
803
1 country
89
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2007
89 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 10, 2008
CompletedFirst Posted
Study publicly available on registry
January 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedResults Posted
Study results publicly available
July 30, 2012
CompletedFebruary 12, 2013
February 1, 2013
1.8 years
January 10, 2008
April 26, 2012
February 6, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline and Weeks 29-36
Secondary Outcomes (2)
Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods
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)
Weeks 29 to 36
Study Arms (2)
Peginesatide
EXPERIMENTALEpoetin alfa
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- Temporary (untunneled) dialysis access catheter.
- A scheduled kidney transplant
- A scheduled surgery that may be expected to lead to significant blood loss.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (89)
Research Facility
Paragould, Arkansas, 72450, United States
Research Facility
Fairfield, California, 94533, United States
Research Facility
Granada Hills, California, 91344, United States
Research Facility
Los Alamitos, California, 90720, United States
Research Facility
Los Angeles, California, 90022, United States
Research Facility
Los Angeles, California, 90033, United States
Research Facility
Los Angeles, California, 90095, United States
Research Facility
Lynwood, California, 90262, United States
Research Facility
Monterey Park, California, 91754, United States
Research Facility
Mountain View, California, 94041, United States
Research Facility
Paramount, California, 90723, United States
Research Facilities (2)
San Diego, California, 92123, United States
Research Facility
San Dimas, California, 91773, United States
Research Facility
Whittier, California, 90603, United States
Research Facility
Denver, Colorado, 80230, United States
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Middlebury, Connecticut, 06762, United States
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Hudson, Florida, 34667, United States
Research Facility
Ocala, Florida, 34471, United States
Research Facility
Orlando, Florida, 32804, United States
Research Facility
Orlando, Florida, 32806, United States
Research Facility
Pembroke Pines, Florida, 33028, United States
Research Facility
Augusta, Georgia, 30901, United States
Research Facility
Augusta, Georgia, 30912, United States
Research Facility
Decatur, Georgia, 30030, United States
Research Facility
Marietta, Georgia, 30060, United States
Research Facility
Honolulu, Hawaii, 96817, United States
Research Facility
Boise, Idaho, 83706, United States
Research Facility
Chicago, Illinois, 60661, United States
Research Facility
Evergreen Park, Illinois, 60805, United States
Research Facility
Gurnee, Illinois, 60031, United States
Research Facility
Peoria, Illinois, 61603, United States
Research Facility
Evansville, Indiana, 47714, United States
Research Facility
Wichita, Kansas, 67214, United States
Research Facility
Lexington, Kentucky, 40513, United States
Research Facility
Baton Rouge, Louisiana, 70809, United States
Research Facility
Lafayette, Louisiana, 70506, United States
Research Facility
New Orleans, Louisiana, 70112, United States
Research Facility
Shreveport, Louisiana, 71101, United States
Research Facility
Bethesda, Maryland, 20817, United States
Research Facility
Rockville, Maryland, 20852, United States
Research Facility
Fall River, Massachusetts, 02720, United States
Research Facility
Worcester, Massachusetts, 01605, United States
Research Facility
Dearborn, Michigan, 48195, United States
Research Facility
Kalamazoo, Michigan, 49007, United States
Research Facility
Columbus, Mississippi, 39705, United States
Research Facility
Tupelo, Mississippi, 38801, United States
Research Facility
St Louis, Missouri, 63110, United States
Research Facility
Las Vegas, Nevada, 89106, United States
Research Facility
Eatontown, New Jersey, 07724, United States
Research Facility
Brooklyn, New York, 11212, United States
Research Facility
New York, New York, 10128, United States
Research Facility
The Bronx, New York, 10461, United States
Research Facility
The Bronx, New York, 10467, United States
Research Facility
Williamsville, New York, 14221, United States
Research Facility
Yonkers, New York, 10710, United States
Research Facility
Durham, North Carolina, 27704, United States
Research Facility
Raleigh, North Carolina, 27609, United States
Research Facility
Canton, Ohio, 44718, United States
Research Facility
Cincinnati, Ohio, 45267, United States
Research Facility
Columbus, Ohio, 43210, United States
Research Facility
Roseburg, Oregon, 97471, United States
Research Facility
Allentown, Pennsylvania, 18103, United States
Research Facility
Philadelphia, Pennsylvania, 19106, United States
Research Facility
Philadelphia, Pennsylvania, 19144, United States
Research Facility
Pittsburgh, Pennsylvania, 15224, United States
Research Facilities (2)
Greenville, South Carolina, 29605, United States
Research Facility
Sumter, South Carolina, 29150, United States
Research Facility
Dyersburg, Tennessee, 38024, United States
Research Facility
Knoxville, Tennessee, 37923, United States
Research Facility
Nashville, Tennessee, 37205, United States
Research Facility
Arlington, Texas, 76011, United States
Research Facility
Fort Worth, Texas, 76105, United States
Research Facility
Fort Worth, Texas, 76106, United States
Research Facility
Fort Worth, Texas, 76133, United States
Research Facility
Grand Prairie, Texas, 75050, United States
Research Facilities (2)
Houston, Texas, 77054, United States
Research Facility
Houston, Texas, 77091, United States
Research Facility
McAllen, Texas, 78503, United States
Research Facility
San Antonio, Texas, 78205, United States
Research Facility
San Antonio, Texas, 78229, United States
Research Facility
Tyler, Texas, 75701, United States
Research Facility
Alexandria, Virginia, 22304, United States
Research Facility
Chesapeake, Virginia, 23320, United States
Research Facility
Fairfax, Virginia, 22030, United States
Research Facility
Mechanicsville, Virginia, 23116, United States
Research Facilities (2)
Norfolk, Virginia, 23507, United States
Research Facility
Morgantown, West Virginia, 26506, United States
Research Facility
Appleton, Wisconsin, 54956, United States
Research Facility
Oshkosh, Wisconsin, 54904, United States
Related Publications (2)
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.
PMID: 23343061RESULTMacdougall 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.
PMID: 23343062DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President, Clinical Development
- Organization
- Affymax
Study Officials
- STUDY DIRECTOR
Vice President, Clinical Development
Affymax
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2008
First Posted
January 18, 2008
Study Start
September 1, 2007
Primary Completion
July 1, 2009
Study Completion
January 1, 2010
Last Updated
February 12, 2013
Results First Posted
July 30, 2012
Record last verified: 2013-02