Open-label Study to Assess the Long-term Safety and Efficacy of Etelcalcetide (Also Known as AMG 416 or KAI-4169) in Patients With Secondary Hyperparathyroidism
NCT ID: NCT01576146
Last Updated: 2017-04-13
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
30 participants
INTERVENTIONAL
2012-03-31
2014-05-01
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 received a bolus IV injection of etelcalcetide 3 times a week (TIW) at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range.
Etelcalcetide
Administered as an intravenous bolus three times a week at the end of each hemodialysis session at dosages up to a maximum of 15 mg.
Interventions
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Etelcalcetide
Administered as an intravenous bolus three times a week at the end of each hemodialysis session at dosages up to a maximum of 15 mg.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject completed the 12 week treatment phase in the parent study study 20120331 ( KAI-4169-005; NCT01414114).
Exclusion Criteria
18 Years
ALL
No
Sponsors
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KAI Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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M D
Role: STUDY_DIRECTOR
Amgen
Other Identifiers
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20120334
Identifier Type: OTHER
Identifier Source: secondary_id
KAI-4169-005-01
Identifier Type: -
Identifier Source: org_study_id
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