Evaluation of Two Epoetin Alfa Dosing Strategies in Subjects With Chronic Kidney Disease Receiving Hemodialysis
NCT ID: NCT02253654
Last Updated: 2017-05-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
216 participants
INTERVENTIONAL
2015-04-01
2016-05-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Epoetin alfa Alternative Titration
Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
Epoetin alfa
Administered intravenously (IV) three times a week (TIW) by appropriately trained healthcare professionals during hemodialysis.
Epoetin alfa USPI Titration
Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
Epoetin alfa
Administered intravenously (IV) three times a week (TIW) by appropriately trained healthcare professionals during hemodialysis.
Interventions
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Epoetin alfa
Administered intravenously (IV) three times a week (TIW) by appropriately trained healthcare professionals during hemodialysis.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18 or older
* Prescribed hemodialysis three times a week (TIW) for ≥ 12 weeks prior to randomization
* Prescribed IV administration of epoetin alfa TIW for ≥ 12 weeks prior to randomization
* Prescribed ≥ 3000 Units/week (ie, ≥ 1000 Units/administration) and \< 90,000 Units/week (ie, \< 30,000 Units/administration) of epoetin alfa during the 4 weeks prior to randomization
* Received ≥ 4 doses of epoetin alfa during the 2 weeks prior to randomization
* Hemoglobin concentration ≤ 11.0 g/dL, per the most recent local laboratory value obtained during the 2 weeks prior to randomization
* Hemoglobin concentration ≤ 11.0 g/dL, at the screening visit, using the hemoglobin point of care device provided by Amgen
* Iron replete, defined as a transferrin saturation (TSAT) ≥ 20% and a ferritin ≥ 100 ng/mL, per the most recent local laboratory value obtained during the 4 weeks prior to randomization
Exclusion Criteria
* Other investigational procedures while participating in this study are excluded
* Systemic hematologic disease (eg, sickle cell anemia, myelodysplastic syndrome, hematologic malignancy)
* Current or prior malignancy within 5 years of randomization, with the exception of non-melanoma skin cancers, cervical or breast ductal carcinoma in situ
* Treatment for any malignancy (eg, radiation, chemotherapy, hormone therapy or biologics) within 5 years of randomization, with the exception of locally excised non-melanoma skin cancers, cervical or breast ductal carcinoma in situ
* Subject is currently pregnant or planning to become pregnant during treatment and for 30 days after the end of treatment
* Subject is currently breast feeding or planning on breast feeding during treatment and for 30 days after the end of treatment
* Females of reproductive potential who are not willing to use an acceptable method of effective contraception during treatment and for at least 30 days after the end of treatment
* Currently receiving IV antibiotics
* Currently receiving systemic immunosuppressive therapy known to cause anemia, including treatment for active hepatitis (eg, azathioprine, mycophenolate mofetil, ≥ 10 mg prednisone \[or equivalent\]/day, interferon)
* Known human immunodeficiency virus (HIV) positive
* Known neutralizing anti-erythropoietic protein antibodies
* Known sensitivity to epoetin alfa
* Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, planned vacations where away from dialysis unit for more than 2 weeks) to the best of the subject and investigator's knowledge
* History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
* Previously entered this study
* Occurrence of any of the following within 8 weeks prior to randomization:
* Seizure
* Clinically relevant active bleeding (eg, gastrointestinal bleed)
* RBC transfusion
* Any hospitalization or observational stay \> 24 hours
* Uncontrolled hypertension, per the investigator within the 4 weeks prior to randomization
* Expected or scheduled solid organ transplant(eg, kidney) within 40 weeks after randomization
* Expected or scheduled to change dialysis modality (eg, peritoneal dialysis, home hemodialysis) within 40 weeks after randomization
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Cerritos, California, United States
Research Site
Glendale, California, United States
Research Site
Los Angeles, California, United States
Research Site
Los Angeles, California, United States
Research Site
Montebello, California, United States
Research Site
Riverside, California, United States
Research Site
San Diego, California, United States
Research Site
Simi Valley, California, United States
Research Site
Vacaville, California, United States
Research Site
Whittier, California, United States
Research Site
Miami, Florida, United States
Research Site
Miami Gardens, Florida, United States
Research Site
Pembroke Pines, Florida, United States
Research Site
Macon, Georgia, United States
Research Site
Statesboro, Georgia, United States
Research Site
Merrillville, Indiana, United States
Research Site
Michigan City, Indiana, United States
Research Site
Detroit, Michigan, United States
Research Site
Pontiac, Michigan, United States
Research Site
Roseville, Michigan, United States
Research Site
Kansas City, Missouri, United States
Research Site
Lincoln, Nebraska, United States
Research Site
Astoria, New York, United States
Research Site
Brooklyn, New York, United States
Research Site
Rosedale, New York, United States
Research Site
The Bronx, New York, United States
Research Site
Carrboro, North Carolina, United States
Research Site
Wilmington, North Carolina, United States
Research Site
Meadville, Pennsylvania, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Houston, Texas, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Burlington, Vermont, United States
Research Site
Hampton, Virginia, United States
Research Site
Norfolk, Virginia, United States
Research Site
Toa Baja, , Puerto Rico
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20110208
Identifier Type: -
Identifier Source: org_study_id
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