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An Open-label, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Etelcalcetide (AMG 416) in Paediatric Subjects Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Maintenance Haemodialysis
This is a study to evaluate the safety and pharmacokinetics in pediatric patients with secondary hyperparathyroidism receiving a single dose of etelcalcetide at the end of hemodialysis.
Age
2 - 17 years
Sex
ALL
Healthy Volunteers
No
Research Site
Los Angeles, California, United States
Research Site
Louisville, Kentucky, United States
Research Site
Kansas City, Missouri, United States
Research Site
Brussels, Belgium
Research Site
Ghent, Belgium
Research Site
Leuven, Belgium
Research Site
Cologne, Germany
Research Site
Hanover, Germany
Research Site
Heidelberg, Germany
Research Site
Marburg, Germany
Start Date
March 14, 2017
Primary Completion Date
October 31, 2018
Completion Date
October 31, 2018
Last Updated
July 10, 2019
11
ACTUAL participants
Etelcalcetide
DRUG
Lead Sponsor
Amgen
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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