A Single-dose Study in Paediatric Subjects Aged 2 to Less Than 18 Years With (sHPT) Receiving Haemodialysis
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This is a multicenter, open-label study to evaluate the safety and pharmacokinetics in pediatric subjects with secondary hyperparathyroidism receiving a single dose of AMG 416 at the end of hemodialysis.
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Ages Eligible for Study:
2 Years to 17 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subject's parent has provided informed consent and subject has provided assent
Children Age 2 to less than 18 years
Diagnosed with chronic kidney disease
Diagnosed with secondary hyperparathyroidism receiving hemodialysis,
Weighing at least 7 kg
Laboratory results within specified range.
Currently receiving treatment in another investigation device or drug study
Subject has received cinacalcet therapy within 30 days
History of prolongation QT interval
Subject is taking any medications that are on the QT prolongation mediation list
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.