Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide
NCT ID: NCT01932970
Last Updated: 2018-10-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
158 participants
INTERVENTIONAL
2013-08-12
2017-02-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Etelcalcetide
Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
Etelcalcetide
Etelcalcetide is provided as a sterile lyophilized powder to be reconstituted with sterile water for injection.
Interventions
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Etelcalcetide
Etelcalcetide is provided as a sterile lyophilized powder to be reconstituted with sterile water for injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject must be receiving maintenance hemodialysis 3 times weekly for at least 8 weeks.
* Subject must have SHPT as defined by having a mean of 3 consecutive central laboratory screening predialysis serum parathyroid hormone (PTH) values ≥ 200 pg/mL, with measurements obtained from 3 different calendar weeks in the 4-week screening period while receiving cinacalcet.
* Subject must have a mean of 3 consecutive central laboratory screening predialysis serum corrected calcium (cCa) values ≥ 7.5 mg/dL, with measurements obtained from 3 different calendar weeks in the 4-week screening period while receiving cinacalcet.
* Subject must be on a stable dose of cinacalcet before screening (defined as no dose change within the 4 weeks prior to screening).
Exclusion Criteria
* Subject has received AMG 416 in a prior clinical trial of AMG 416 (also known as KAI-4169).
* Subject has known sensitivity to any of the products or components of AMG 416 to be administered during dosing.
* Subject is unwilling to use effective contraception during the study, and for women, up to a period of up to 3 months after the last dose of AMG 416.
* Subject is pregnant or nursing.
* Anticipated or scheduled parathyroidectomy during the study period.
* Subject has received a parathyroidectomy within 6 months prior to dosing.
18 Years
100 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
Alhambra, California, United States
Research Site
Azusa, California, United States
Research Site
Bakersfield, California, United States
Research Site
Chula Vista, California, United States
Research Site
La Mesa, California, United States
Research Site
Los Angeles, California, United States
Research Site
Lynwood, California, United States
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Riverside, California, United States
Research Site
Whittier, California, United States
Research Site
Arvada, Colorado, United States
Research Site
North Haven, Connecticut, United States
Research Site
Coral Springs, Florida, United States
Research Site
Hollywood, Florida, United States
Research Site
Miami, Florida, United States
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Pembroke Pines, Florida, United States
Research Site
Pinecrest, Florida, United States
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Tampa, Florida, United States
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Augusta, Georgia, United States
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Evergreen Park, Illinois, United States
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Michigan City, Indiana, United States
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Baton Rouge, Louisiana, United States
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Lafayette, Louisiana, United States
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Columbus, Mississippi, United States
Research Site
Gulfport, Mississippi, United States
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Farmington, Missouri, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Portsmouth, New Hampshire, United States
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Eatontown, New Jersey, United States
Research Site
College Point, New York, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Orangeburg, South Carolina, United States
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Arlington, Texas, United States
Research Site
Greenville, Texas, United States
Research Site
Houston, Texas, United States
Research Site
McAllen, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Fairfax, Virginia, United States
Research Site
Hampton, Virginia, United States
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2013-000964-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
KAI-4169
Identifier Type: OTHER
Identifier Source: secondary_id
20120359
Identifier Type: -
Identifier Source: org_study_id
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