Safety & Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis
NCT ID: NCT00598273
Last Updated: 2013-02-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
490 participants
INTERVENTIONAL
2007-10-31
2010-02-28
Brief Summary
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Detailed Description
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Erythropoiesis stimulating agents 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.
Study participants received doses of peginesatide administered once every 4 weeks or darbepoetin alfa administered once every 2 weeks. Total commitment time for this study was a 4 week screening period followed by a minimum of 52 weeks of study treatment. Eligible participants were randomized in equal proportions to two peginesatide treatment regimens and one control, darbepoetin alfa, treatment regimen.
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 0.025 mg/kg
peginesatide
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
Peginesatide 0.04 mg/kg
peginesatide
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
Darbepoetin Alfa
Darbepoetin alfa
As prescribed, starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
Interventions
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peginesatide
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
peginesatide
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
Darbepoetin alfa
As prescribed, starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Two consecutive hemoglobin values ≥ 8.0 g/dL and \< 11.0 g/dL within 4 weeks prior to randomization.
Exclusion Criteria
2. Treatment with an ESA in the 12 weeks prior to randomization.
3. Known intolerance to any ESA, parenteral iron supplementation, or pegylated molecule.
4. Prior chronic hemodialysis or chronic peritoneal dialysis treatment.
5. Known bleeding or coagulation disorder.
6. Known hematologic disease or cause of anemia other than renal disease
7. Poorly controlled hypertension
8. Evidence of active malignancy within one year prior to randomization.
9. A scheduled kidney transplant
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
Montgomery, Alabama, United States
Research Facility
Tempe, Arizona, United States
Research Facility
Hot Springs, Arkansas, United States
Research Facility
Bakersfield, California, United States
Research Facility
Chula Vista, California, United States
Research Facility
Glendale, California, United States
Research Facility
Huntington Beach, California, United States
Research Facility
Los Angeles, California, United States
Research Facility
Orange, California, United States
Research Facility
Paramount, California, United States
Research Facility
Pasadena, California, United States
Research Facility
Riverside, California, United States
Research Facility
San Dimas, California, United States
Research Facility
Stanford, California, United States
Research Facility
Whittier, California, United States
Research Facility
Whittier, California, United States
Research Facility
Yuba City, California, United States
Research Facility
Thornton, Colorado, United States
Research Facility
Washington D.C., District of Columbia, United States
Research Facility
Holly Hill, Florida, United States
Research Facility
Hudson, Florida, United States
Research Facility
Miami, Florida, United States
Research Facility
Ocala, Florida, United States
Research Facility
Orlando, Florida, United States
Research Facility
Tampa, Florida, United States
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Augusta, Georgia, United States
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Honolulu, Hawaii, United States
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Chicago, Illinois, United States
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Evergreen Park, Illinois, United States
Research Facility
Hines, Illinois, United States
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Evansville, Indiana, United States
Research Facility
Lafayette, Indiana, United States
Research Facility
Wichita, Kansas, United States
Research Facility
Shreveport, Louisiana, United States
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Bethesda, Maryland, United States
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Fall River, Massachusetts, United States
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Worcester, Massachusetts, United States
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Midland, Michigan, United States
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Columbus, Mississippi, United States
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Kansas City, Missouri, United States
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Northfield, New Jersey, United States
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Toms River, New Jersey, United States
Research Facility
Binghamton, New York, United States
Research Facility
Great Neck, New York, United States
Research Facility
Mineola, New York, United States
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Charlotte, North Carolina, United States
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Oklahoma City, Oklahoma, United States
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Bend, Oregon, United States
Research Facility
Portland, Oregon, United States
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Allentown, Pennsylvania, United States
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Erie, Pennsylvania, United States
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Johnstown, Pennsylvania, United States
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Providence, Rhode Island, United States
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Orangeburg, South Carolina, United States
Research Facility
Rock Hill, South Carolina, United States
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Clarksville, Tennessee, United States
Research Facility
Knoxville, Tennessee, United States
Research Facility
Nashville, Tennessee, United States
Research Facility
Austin, Texas, United States
Research Facility
Corpus Christi, Texas, United States
Research Facility
Corsicana, Texas, United States
Research Facility
Edinburg, Texas, United States
Research Facility
Houston, Texas, United States
Research Facility
Houston, Texas, United States
Research Facility
San Antonio, Texas, United States
Research Facility
San Antonio, Texas, United States
Research Facility
Salem, Virginia, United States
Research Facility
Bluefield, West Virginia, United States
Research Facility
Caguas, , Puerto Rico
Research Facility
Ponce, , Puerto Rico
Research Facility
San Juan, , Puerto Rico
Research Facility
San Juan, , Puerto Rico
Countries
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References
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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.
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.
Other Identifiers
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AFX01-11
Identifier Type: -
Identifier Source: org_study_id
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