An Efficacy and Safety Study of Epoetin Alfa for Initiation and Maintenance Treatment of Patients With Anemia Associated With Chronic Kidney Disease
A Randomized, Open Label, Multicenter Study of Epoetin Alfa Comparing Two Extended-Dosing Regimens, Once-Weekly and Every-Two-Weeks, With the Three-Times-Weekly Dosing Regimen for Initiation and Maintenance Treatment in Anemic Subjects With Chronic Kidney Disease
2 other identifiers
interventional
375
2 countries
62
Brief Summary
The purpose of this study is to demonstrate that once weekly and once every-2-weeks treatment with epoetin alfa, in patients with anemia associated with chronic kidney disease, is not less effective than the approved treatment with epoetin alfa that is given 3 times weekly with respect to changes in hemoglobin.
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 Sep 2006
62 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 26, 2007
CompletedFirst Posted
Study publicly available on registry
February 27, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedResults Posted
Study results publicly available
February 8, 2010
CompletedMay 7, 2014
April 1, 2014
1.4 years
February 26, 2007
February 23, 2009
April 22, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Hb Concentration (g/dL) From Baseline to the Average of the Last 8 Weeks of Treatment Through Week 22
The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included in calculating the average Hb during the last 8 weeks of treatment through Week 22.
From baseline through Week 22
Secondary Outcomes (1)
Participants With an Increase of ≥1 g/dL in Hb Concentration From Baseline by Week 9
From baseline to Week 9
Other Outcomes (5)
Participants Who Exceeded a Hb Concentration of 11.9 g/dL During First 22 Weeks of Treatment
From baseline to Week 22
Maximum Hb Concentration (g/dL) During First 22 Weeks of Treatment
From baseline to Week 22
Participants Who Met or Exceeded Hb Rate of Rise >=1.0 g/dL/2 Weeks During First 22 Weeks of Treatment
From baseline to Week 22
- +2 more other outcomes
Study Arms (3)
TIW: Epoetin alfa 3 injections Weekly/Once Weekly
EXPERIMENTALParticipants will be administered with epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
QW: Epoetin alfa once weekly
EXPERIMENTALParticipants will be administered with epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU).
Q2W: Epoetin alfa once every two weeks
EXPERIMENTALParticipants will be administered with epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU).
Interventions
Epoetin alfa will be administered as a SC injections at initial dose of 50 IU/kg (3 times weekly for 22 weeks) and at initial dose of 10000 IU (once weekly for 22 weeks)
Epoetin alfa will be administered as a SC injection at initial dose of 10000 IU (once weekly for 44 weeks).
Epoetin alfa will be administered as a SC injection at initial dose of 20000 IU (once every 2 weeks for 44 weeks).
Eligibility Criteria
You may qualify if:
- Meet the diagnostic criteria for chronic kidney disease, defined as a glomerular filtration rate (GFR) more than or equal to 15 mL/min per 1.73 m2 and less than 60 mL/min per 1.73 m2 (Stages 3 and 4) as calculated by the central laboratory
- Require support of an erythropoietin receptor agonist
You may not qualify if:
- Uncontrolled hypertension
- Serum ferritin level less than 50 ng/mL
- Serum iron overload
- Severe congestive heart failure
- Active infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (62)
Unknown Facility
Glendale, Arizona, United States
Unknown Facility
Tempe, Arizona, United States
Unknown Facility
Chula Vista, California, United States
Unknown Facility
Long Beach, California, United States
Unknown Facility
Los Angeles, California, United States
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Lynwood, California, United States
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Riverside, California, United States
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San Diego, California, United States
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Visalia, California, United States
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Whittier, California, United States
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Yuba City, California, United States
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Colorado Springs, Colorado, United States
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Lakewood, Colorado, United States
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Thornton, Colorado, United States
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Lauderdale Lakes, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Palm Beach Gardens, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Zephyrhills, Florida, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Carrollton, Georgia, United States
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Macon, Georgia, United States
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Statesboro, Georgia, United States
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Chicago, Illinois, United States
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Peoria, Illinois, United States
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
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Methuen, Massachusetts, United States
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Plymouth, Massachusetts, United States
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Flint, Michigan, United States
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Hackensack, New Jersey, United States
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Old Bridge, New Jersey, United States
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Vineland, New Jersey, United States
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Albuquerque, New Mexico, United States
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Great Neck, New York, United States
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New Hartford, New York, United States
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New York, New York, United States
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Springfield Gardens, New York, United States
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Charlotte, North Carolina, United States
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Greenville, North Carolina, United States
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Maumee, Ohio, United States
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Doylestown, Pennsylvania, United States
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Easton, Pennsylvania, United States
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Erie, Pennsylvania, United States
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Lancaster, Pennsylvania, United States
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Wynnewood, Pennsylvania, United States
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Bamberg, South Carolina, United States
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Orangeburg, South Carolina, United States
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Sumter, South Carolina, United States
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Dyersburg, Tennessee, United States
Unknown Facility
Arlington, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Chesapeake, Virginia, United States
Unknown Facility
Fairfax, Virginia, United States
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Hampton, Virginia, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Tacoma, Washington, United States
Unknown Facility
Caguas, Puerto Rico
Related Publications (1)
Pergola PE, Gartenberg G, Fu M, Wolfson M, Rao S, Bowers P. A randomized controlled study of weekly and biweekly dosing of epoetin alfa in CKD Patients with anemia. Clin J Am Soc Nephrol. 2009 Nov;4(11):1731-40. doi: 10.2215/CJN.03470509. Epub 2009 Sep 17.
PMID: 19808215DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr Director of Clinical Research
- Organization
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research and Development, L.L C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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
February 26, 2007
First Posted
February 27, 2007
Study Start
September 1, 2006
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
May 7, 2014
Results First Posted
February 8, 2010
Record last verified: 2014-04