Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis
EMERALD 2
AFX01-14: 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
2 other identifiers
interventional
823
9 countries
84
Brief Summary
The purpose of this 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 Oct 2007
84 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
October 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
CompletedMarch 8, 2013
March 1, 2013
1.8 years
January 10, 2008
April 26, 2012
March 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 to 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
ACTIVE COMPARATORInterventions
Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study. 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.
Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta 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 IV epoetin alfa or beta 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 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 (84)
Research Facility
Phoenix, Arizona, 85012, United States
Research Facility
Hot Springs, Arkansas, 71901, United States
Research Facility
McGehee, Arkansas, 71654, United States
Research Facility
Pine Bluff, Arkansas, 71603, United States
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Bakersfield, California, 93309, United States
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Glendale, California, 91205, United States
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Los Angeles, California, 90033, United States
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Los Angeles, California, 90048, United States
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Los Angeles, California, 90073, United States
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Riverside, California, 92505, United States
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Simi Valley, California, 93065, United States
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Whittier, California, 90602, United States
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Yuba City, California, 95991, United States
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Westminster, Colorado, 80031, United States
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Lauderdale Lakes, Florida, 33313, United States
Research Facility
Miami, Florida, 33173, United States
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Pinecrest, Florida, 33156, United States
Research Facility
Flossmoor, Illinois, 60422, United States
Research Facility
Hines, Illinois, 60141, United States
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Louisville, Kentucky, 40202, United States
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Rockville, Maryland, 20850, United States
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Springfield, Massachusetts, 01107, United States
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Detroit, Michigan, 48202, United States
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Detroit, Michigan, 48236, United States
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Brookhaven, Mississippi, 39601, United States
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Brooklyn, New York, 11238, United States
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Flushing, New York, 11355, United States
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The Bronx, New York, 10461, United States
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Asheville, North Carolina, 28801, United States
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Toledo, Ohio, 43606, United States
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Oklahoma City, Oklahoma, 73116, United States
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Erie, Pennsylvania, 16507, United States
Research Facility
Philadelphia, Pennsylvania, 19141, United States
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Providence, Rhode Island, 02904, United States
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Orangeburg, South Carolina, 29118, United States
Research Facility
Arlington, Texas, 76015, United States
Research Facility
Houston, Texas, 77099, United States
Research Facility
San Antonio, Texas, 78215, United States
Research Facility
Fairfax, Virginia, 22033, United States
Research Facility
Burgas, 8000, Bulgaria
Research Facility
Pazardzhik, 4400, Bulgaria
Research Facility
Pleven, 5800, Bulgaria
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Plovdiv, 4000, Bulgaria
Research Facility
Plovdiv, 4003, Bulgaria
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Rousse, 7002, Bulgaria
Research Facility
Sofia, 1309, Bulgaria
Research Facilities (2)
Sofia, 1431, Bulgaria
Research Facility
Sofia, 1527, Bulgaria
Research Facility
Sofia, 1606, Bulgaria
Research Facility
Varna, 9010, Bulgaria
Research Facility
Veliko Tarnovo, 5000, Bulgaria
Research Facility
Amiens, 80054, France
Research Facility
Bordeaux, 33000, France
Research Facility
Montpellier, 34295, France
Research Facility
Vannes, 56017, France
Research Facilities (2)
Bremen, 28359, Germany
Research Facility
Franfurt, 60528, Germany
Research Facility
Hamburg, 22297, Germany
Research Facility
Kaiserslautern, 67655, Germany
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Como, 22100, Italy
Research Facility
Cremona, 26100, Italy
Research Facility
Lecco, 23900, Italy
Research Facility
Modena, 41100, Italy
Research Facility
Prato, 59100, Italy
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Ciechanów, 06-400, Poland
Research Facility
Katowice, 40-027, Poland
Research Facility
Pabianice, 95-200, Poland
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Włocławek, 87-800, Poland
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Bucharest, 014461, Romania
Research Facility
Bucharest, 050098, Romania
Research Facility
Iași, 700503, Romania
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Alicante, 03010, Spain
Research Facility
Barcelona, 08025, Spain
Research Facility
Barcelona, 08902, Spain
Research Facility
Barcelona, 08907, Spain
Research Facility
Ciudad Real, 13005, Spain
Research Facility
Madrid, 28041, Spain
Research Facility
Madrid, 28922, Spain
Research Facility
Santander, 39008, Spain
Research Facility
Carshalton, SM5 1AA, United Kingdom
Research Facility
London, E1 1BB, United Kingdom
Research Facility
London, SE5 9RS, United Kingdom
Research Facility
London, SW17 0QT, United Kingdom
Research Facility
Swansea, SA6 6NL, United Kingdom
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
October 1, 2007
Primary Completion
July 1, 2009
Study Completion
January 1, 2010
Last Updated
March 8, 2013
Results First Posted
July 30, 2012
Record last verified: 2013-03