Safety and Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis
PEARL 2
AFX01-13: A Phase 3, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Peginesatide for the Correction of Anemia in Patients With Chronic Renal Failure (CRF) Not on Dialysis and Not on Erythropoiesis Stimulating Agent (ESA) Treatment
2 other identifiers
interventional
493
10 countries
64
Brief Summary
The purpose of this study was to evaluate the safety and efficacy of peginesatide for the treatment of anemia in participants with chronic kidney disease, who are not on dialysis and not on erythropoiesis stimulating agent (ESA) treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2007
64 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
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 10, 2008
CompletedFirst Posted
Study publicly available on registry
January 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
July 30, 2012
CompletedFebruary 12, 2013
February 1, 2013
1.7 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 three hemoglobin values: the two 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 25 through 36.
Baseline and Weeks 25-36
Secondary Outcomes (2)
Proportion of Participants Who Received Red Blood Cell (RBC) Transfusions During the Correction and Evaluation Periods
Weeks 0 to 36
Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods
Weeks 0 to 36
Study Arms (3)
Peginesatide 0.025 mg/kg
EXPERIMENTALPeginesatide 0.04 mg/kg
EXPERIMENTALDarbepoetin alfa
ACTIVE COMPARATORInterventions
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).
Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
Eligibility Criteria
You may qualify if:
- Chronic renal failure with an estimated glomerular filtration rate \< 60 milliliters per minute per 1.73 m\^2 and not expected to begin dialysis for at least 12 weeks.
- Two consecutive hemoglobin values ≥ 8.0 g/dL and \< 11.0 g/dL within 4 weeks prior to randomization.
You may not qualify if:
- Females who are pregnant or breast-feeding.
- Treatment with an ESA in the 12 weeks prior to randomization.
- Known intolerance to any ESA, parenteral iron supplementation, or pegylated molecule.
- Prior chronic hemodialysis or chronic peritoneal dialysis treatment.
- 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
- A scheduled kidney transplant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (64)
Research Facility
Phoenix, Arizona, 85012, United States
Research Facility
Fayetteville, Arkansas, 72703, United States
Research Facility
Fountain Valley, California, 92708, United States
Research Facility
Fullerton, California, 92835, United States
Research Facility
Granada Hills, California, 91344, United States
Research Facility
Los Angeles, California, 90022, United States
Research Facility
San Diego, California, 92123, United States
Research Facility
Whittier, California, 90603, United States
Research Facility
Lauderdale Lakes, Florida, 33313, United States
Research Facility
Pembroke Pines, Florida, 33028, United States
Research Facility
Pinecrest, Florida, 33156, United States
Research Facility
Canton, Georgia, 30114, United States
Research Facility
Columbus, Georgia, 31904, United States
Research Facility
Marietta, Georgia, 30060, United States
Research Facility
Caldwell, Idaho, 83605, United States
Research Facility
Meridian, Idaho, 83642, United States
Research Facility
Chicago, Illinois, 60611, United States
Research Facility
Mishawaka, Indiana, 46545, United States
Research Facility
Ames, Iowa, 50010, United States
Research Facility
Baton Rouge, Louisiana, 70809, United States
Research Facility
Lafayette, Louisiana, 70506, United States
Research Facility
Rockville, Maryland, 20852, United States
Research Facility
Springfield, Massachusetts, 01107, United States
Research Facility
Detroit, Michigan, 48202, United States
Research Facility
Detroit, Michigan, 48236, United States
Research Facility
Flint, Michigan, 48504, United States
Research Facility
Petoskey, Michigan, 49770, United States
Research Facility
Troy, Michigan, 48098, United States
Research Facility
Washington, Missouri, 63090, United States
Research Facility
Flushing, New York, 11355, United States
Research Facility
Williamsville, New York, 14221, United States
Research Facility
Asheville, North Carolina, 28801, United States
Research Facility
Columbus, Ohio, 43210, United States
Research Facility
Bend, Oregon, 97701, United States
Research Facility
Arlington, Texas, 76015, United States
Research Facility
Houston, Texas, 77004, United States
Research Facility
San Antonio, Texas, 78229, United States
Research Facility
Burlington, Vermont, 05401, United States
Research Facility
Fairfax, Virginia, 22030, United States
Research Facility
Tacoma, Washington, 98405, United States
Research Facility
Morgantown, West Virginia, 26506, United States
Research Facility
Neenah, Wisconsin, 54956, United States
Research Facility
Sofia, 1431, Bulgaria
Research Facility
Sofia, 1606, Bulgaria
Research Facility
Varna, 9000, Bulgaria
Research Facility
Veliko Tarnovo, 5000, Bulgaria
Research Facility
Prague, 14021, Czechia
Research Facility
Tábor, 39003, Czechia
Research Facility
Zdar, 591 01, Czechia
Research Facility
Demmin, 17109, Germany
Research Facility
Balatonfüred, 8230, Hungary
Research Facility
Kistarcsa, 2143, Hungary
Research Facility
Szigetvár, 7900, Hungary
Research Facility
Lecco, 23900, Italy
Research Facility
Pavia, 27100, Italy
Research Facility
Bialystok, 15 540, Poland
Research Facility
Gdansk, 80 952, Poland
Research Facility
Katowice, 40 027, Poland
Research Facility
Zamość, 22 400, Poland
Research Facility
Ponce, 00717-0634, Puerto Rico
Research Facility
Iași, 700 503, Romania
Research Facility
Oradea, 410469, Romania
Research Facility
Timișoara, 300 736, Romania
Research Facility
London, SE5 9RS, United Kingdom
Related Publications (2)
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.
PMID: 23343062RESULTFishbane 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: 23343061DERIVED
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 21, 2008
Study Start
November 1, 2007
Primary Completion
July 1, 2009
Study Completion
December 1, 2009
Last Updated
February 12, 2013
Results First Posted
July 30, 2012
Record last verified: 2013-02