Safety, Tolerability and Efficacy of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism
NCT ID: NCT01254565
Last Updated: 2017-04-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
87 participants
INTERVENTIONAL
2011-02-20
2011-08-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Etelcalcetide
Participants received etelcalcetide administered by intravenous injection at the end of each hemodialysis session three times a week (TIW). The starting dose level was 5 mg; dose escalation was to proceed to 10 and 20 mg pending safety review of the prior cohort.
Etelcalcetide
Administered intravenously (IV) at the end of hemodialysis
Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW).
Placebo
Administered intravenously at the end of hemodialysis
Interventions
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Etelcalcetide
Administered intravenously (IV) at the end of hemodialysis
Placebo
Administered intravenously at the end of hemodialysis
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Intact parathyroid hormone (PTH) at least 350 pg/mL.
* Corrected calcium at least 9.0 mg/dL.
* Hemoglobin at least 9.0 g/dL.
* Adequate hemodialysis three times per week.
* Excepting chronic renal failure, subject is judged to be in stable medical condition based on medical history, physical examination, and routine laboratory tests.
Exclusion Criteria
* History of angina pectoris or congestive heart failure
* History of myocardial infarction, coronary angioplasty, or coronary artery bypass grafting within the past 6 months.
* History of or treatment for seizure disorder.
* Recent (3 months) parathyroidectomy.
* Serum transaminases (alanine aminotransferase, aspartate aminotransferase) greater than two times the upper limit of normal at screening.
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
Locations
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Azusa, California, United States
Costa Mesa, California, United States
Lynwood, California, United States
Riverside, California, United States
San Diego, California, United States
Denver, Colorado, United States
Macon, Georgia, United States
Shreveport, Louisiana, United States
Brooklyn Center, Minnesota, United States
Philadelphia, Pennsylvania, United States
Houston, Texas, United States
Houston, Texas, United States
Chesapeake, Virginia, United States
Countries
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Other Identifiers
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20120330
Identifier Type: OTHER
Identifier Source: secondary_id
KAI-4169-003
Identifier Type: -
Identifier Source: org_study_id
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