Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis
NCT ID: NCT00597753
Last Updated: 2013-02-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
803 participants
INTERVENTIONAL
2007-09-30
2010-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Peginesatide
peginesatide
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 alfa
Epoetin Alfa
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.
Interventions
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peginesatide
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 Alfa
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. On intravenous epoetin alfa maintenance therapy continuously prescribed for a minimum of 8 weeks prior to randomization.
3. Four consecutive hemoglobin values with a mean ≥ 10.0 and ≤ 12.0 g/dL during the screening period
Exclusion Criteria
2. Known intolerance to any erythropoiesis stimulating agent (ESA) or pegylated molecule or to all parenteral iron supplementation products.
3. Known bleeding or coagulation disorder.
4. Known hematologic disease or cause of anemia other than renal disease
5. Poorly controlled hypertension
6. Evidence of active malignancy within one year prior to randomization.
7. Temporary (untunneled) dialysis access catheter.
8. A scheduled kidney transplant
9. A scheduled surgery that may be expected to lead to significant blood loss.
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Affymax
INDUSTRY
Responsible Party
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Principal Investigators
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Vice President, Clinical Development
Role: STUDY_DIRECTOR
Affymax
Locations
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Research Facility
Paragould, Arkansas, United States
Research Facility
Fairfield, California, United States
Research Facility
Granada Hills, California, United States
Research Facility
Los Alamitos, California, United States
Research Facility
Los Angeles, California, United States
Research Facility
Los Angeles, California, United States
Research Facility
Los Angeles, California, United States
Research Facility
Lynwood, California, United States
Research Facility
Monterey Park, California, United States
Research Facility
Mountain View, California, United States
Research Facility
Paramount, California, United States
Research Facilities (2)
San Diego, California, United States
Research Facility
San Dimas, California, United States
Research Facility
Whittier, California, United States
Research Facility
Denver, Colorado, United States
Research Facility
Middlebury, Connecticut, United States
Research Facility
Hudson, Florida, United States
Research Facility
Ocala, Florida, United States
Research Facility
Orlando, Florida, United States
Research Facility
Orlando, Florida, United States
Research Facility
Pembroke Pines, Florida, United States
Research Facility
Augusta, Georgia, United States
Research Facility
Augusta, Georgia, United States
Research Facility
Decatur, Georgia, United States
Research Facility
Marietta, Georgia, United States
Research Facility
Honolulu, Hawaii, United States
Research Facility
Boise, Idaho, United States
Research Facility
Chicago, Illinois, United States
Research Facility
Evergreen Park, Illinois, United States
Research Facility
Gurnee, Illinois, United States
Research Facility
Peoria, Illinois, United States
Research Facility
Evansville, Indiana, United States
Research Facility
Wichita, Kansas, United States
Research Facility
Lexington, Kentucky, United States
Research Facility
Baton Rouge, Louisiana, United States
Research Facility
Lafayette, Louisiana, United States
Research Facility
New Orleans, Louisiana, United States
Research Facility
Shreveport, Louisiana, United States
Research Facility
Bethesda, Maryland, United States
Research Facility
Rockville, Maryland, United States
Research Facility
Fall River, Massachusetts, United States
Research Facility
Worcester, Massachusetts, United States
Research Facility
Dearborn, Michigan, United States
Research Facility
Kalamazoo, Michigan, United States
Research Facility
Columbus, Mississippi, United States
Research Facility
Tupelo, Mississippi, United States
Research Facility
St Louis, Missouri, United States
Research Facility
Las Vegas, Nevada, United States
Research Facility
Eatontown, New Jersey, United States
Research Facility
Brooklyn, New York, United States
Research Facility
New York, New York, United States
Research Facility
The Bronx, New York, United States
Research Facility
The Bronx, New York, United States
Research Facility
Williamsville, New York, United States
Research Facility
Yonkers, New York, United States
Research Facility
Durham, North Carolina, United States
Research Facility
Raleigh, North Carolina, United States
Research Facility
Canton, Ohio, United States
Research Facility
Cincinnati, Ohio, United States
Research Facility
Columbus, Ohio, United States
Research Facility
Roseburg, Oregon, United States
Research Facility
Allentown, Pennsylvania, United States
Research Facility
Philadelphia, Pennsylvania, United States
Research Facility
Philadelphia, Pennsylvania, United States
Research Facility
Pittsburgh, Pennsylvania, United States
Research Facilities (2)
Greenville, South Carolina, United States
Research Facility
Sumter, South Carolina, United States
Research Facility
Dyersburg, Tennessee, United States
Research Facility
Knoxville, Tennessee, United States
Research Facility
Nashville, Tennessee, United States
Research Facility
Arlington, Texas, United States
Research Facility
Fort Worth, Texas, United States
Research Facility
Fort Worth, Texas, United States
Research Facility
Fort Worth, Texas, United States
Research Facility
Grand Prairie, Texas, United States
Research Facilities (2)
Houston, Texas, United States
Research Facility
Houston, Texas, United States
Research Facility
McAllen, Texas, United States
Research Facility
San Antonio, Texas, United States
Research Facility
San Antonio, Texas, United States
Research Facility
Tyler, Texas, United States
Research Facility
Alexandria, Virginia, United States
Research Facility
Chesapeake, Virginia, United States
Research Facility
Fairfax, Virginia, United States
Research Facility
Mechanicsville, Virginia, United States
Research Facilities (2)
Norfolk, Virginia, United States
Research Facility
Morgantown, West Virginia, United States
Research Facility
Appleton, Wisconsin, United States
Research Facility
Oshkosh, Wisconsin, United States
Countries
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References
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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.
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.
Other Identifiers
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AFX01-12
Identifier Type: -
Identifier Source: org_study_id
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