Safety & Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis
PEARL 1
AFX01-11: 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
1 other identifier
interventional
490
2 countries
72
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 Oct 2007
72 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 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedResults Posted
Study results publicly available
July 30, 2012
CompletedFebruary 12, 2013
February 1, 2013
1.4 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 Receive 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).
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.
Eligibility Criteria
You may qualify if:
- Chronic renal failure with an estimated glomerular filtration rate \< 60 milliliter per minute per 1.73m\^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 (72)
Research Facility
Montgomery, Alabama, 36106, United States
Research Facility
Tempe, Arizona, 85306, United States
Research Facility
Hot Springs, Arkansas, 71901, United States
Research Facility
Bakersfield, California, 93309, United States
Research Facility
Chula Vista, California, 91910, United States
Research Facility
Glendale, California, 91204, United States
Research Facility
Huntington Beach, California, 92646, United States
Research Facility
Los Angeles, California, 90095, United States
Research Facility
Orange, California, 92868, United States
Research Facility
Paramount, California, 90723, United States
Research Facility
Pasadena, California, 91106, United States
Research Facility
Riverside, California, 92505, United States
Research Facility
San Dimas, California, 91773, United States
Research Facility
Stanford, California, 94305-6203, United States
Research Facility
Whittier, California, 90603, United States
Research Facility
Whittier, California, 90606, United States
Research Facility
Yuba City, California, 95991, United States
Research Facility
Thornton, Colorado, 80031, United States
Research Facility
Washington D.C., District of Columbia, 20037, United States
Research Facility
Holly Hill, Florida, 32117, United States
Research Facility
Hudson, Florida, 34667, United States
Research Facility
Miami, Florida, 33173, United States
Research Facility
Ocala, Florida, 34471, United States
Research Facility
Orlando, Florida, 32804, United States
Research Facility
Tampa, Florida, 33614, United States
Research Facility
Augusta, Georgia, 30901, United States
Research Facility
Honolulu, Hawaii, 96817, United States
Research Facility
Chicago, Illinois, 60616, United States
Research Facility
Evergreen Park, Illinois, 60805, United States
Research Facility
Hines, Illinois, 60141, United States
Research Facility
Evansville, Indiana, 47714, United States
Research Facility
Lafayette, Indiana, 47904, United States
Research Facility
Wichita, Kansas, 67214, United States
Research Facility
Shreveport, Louisiana, 71101, United States
Research Facility
Bethesda, Maryland, 20814, United States
Research Facility
Fall River, Massachusetts, 02720, United States
Research Facility
Worcester, Massachusetts, 01608, United States
Research Facility
Midland, Michigan, 48640, United States
Research Facility
Columbus, Mississippi, 39705, United States
Research Facility
Kansas City, Missouri, 64128, United States
Research Facility
Northfield, New Jersey, 08225, United States
Research Facility
Toms River, New Jersey, 08755, United States
Research Facility
Binghamton, New York, 13903, United States
Research Facility
Great Neck, New York, 11021, United States
Research Facility
Mineola, New York, 11501, United States
Research Facility
Charlotte, North Carolina, 28208, United States
Research Facility
Oklahoma City, Oklahoma, 73116, United States
Research Facility
Bend, Oregon, 97701, United States
Research Facility
Portland, Oregon, 97210, United States
Research Facility
Allentown, Pennsylvania, 18103, United States
Research Facility
Erie, Pennsylvania, 16507, United States
Research Facility
Johnstown, Pennsylvania, 15905, United States
Research Facility
Providence, Rhode Island, 02904, United States
Research Facility
Orangeburg, South Carolina, 29118, United States
Research Facility
Rock Hill, South Carolina, 29732, United States
Research Facility
Clarksville, Tennessee, 37043, United States
Research Facility
Knoxville, Tennessee, 37923, United States
Research Facility
Nashville, Tennessee, 37205, United States
Research Facility
Austin, Texas, 78705, United States
Research Facility
Corpus Christi, Texas, 78404, United States
Research Facility
Corsicana, Texas, 75110, United States
Research Facility
Edinburg, Texas, 78539, United States
Research Facility
Houston, Texas, 77030, United States
Research Facility
Houston, Texas, 77099, United States
Research Facility
San Antonio, Texas, 78215, United States
Research Facility
San Antonio, Texas, 78229, United States
Research Facility
Salem, Virginia, 24153, United States
Research Facility
Bluefield, West Virginia, 24701, United States
Research Facility
Caguas, 00725, Puerto Rico
Research Facility
Ponce, 00716, Puerto Rico
Research Facility
San Juan, 00909, Puerto Rico
Research Facility
San Juan, 00918, Puerto Rico
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
October 1, 2007
Primary Completion
March 1, 2009
Study Completion
February 1, 2010
Last Updated
February 12, 2013
Results First Posted
July 30, 2012
Record last verified: 2013-02