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A Single-dose Study in Paediatric Subjects Aged 2 to Less Than 18 Years With (sHPT) Receiving Haemodialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02833857
Recruitment Status : Completed
First Posted : July 14, 2016
Last Update Posted : December 27, 2018
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease, Secondary Hyperparathyroidism Drug: Study Drug Phase 1

Detailed Description:
A Single-dose Study to Evaluate the Safety and Pharmacokinetics in Paediatric Subjects Aged 2 to less than 18 Years with (sHPT) Receiving Maintenance Haemodialysis

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: An Open-label, Single-dose Study to Evaluate Etelcalcetide (AMG 416) in Paediatric Subjects Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Maintenance Haemodialysis
Actual Study Start Date : March 14, 2017
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: Single dose of study drug
AMG 416
Drug: Study Drug
AMG 416

Primary Outcome Measures :
  1. Common Treatment emergent AEs [ Time Frame: 30 days ]
  2. Changes in Key Laboratory Tests [ Time Frame: 30 days ]
  3. Changes in ECG [ Time Frame: 30 days ]
  4. Changes in Vital Signs [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. AUC (PK parameter) [ Time Frame: 30 days ]
  2. Concentration of parathyroid hormone (PTH) (PD parameter) [ Time Frame: 30 days ]
  3. Anti-drug antibodies [ Time Frame: 30 days ]
  4. Treatment emergent AEs [ Time Frame: 30 days ]
  5. Cmax (PK parameter) [ Time Frame: 30 days ]
  6. Tmax (PK parameter) [ Time Frame: 30 days ]
  7. Serum calcium [total calcium, ionized calcium and albumin corrected calcium] over time (PD parameter) [ Time Frame: 30 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • ECG measurements within specified range.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02833857

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United States, California
Research Site
Los Angeles, California, United States, 90095
United States, Kentucky
Research Site
Louisville, Kentucky, United States, 40202
United States, Missouri
Research Site
Kansas City, Missouri, United States, 64108
Research Site
Bruxelles, Belgium, 1020
Research Site
Gent, Belgium, 9000
Research Site
Leuven, Belgium, 3000
Research Site
Hamburg, Germany, 20246
Research Site
Hannover, Germany, 30625
Research Site
Heidelberg, Germany, 69120
Research Site
Köln, Germany, 50937
Research Site
Marburg, Germany, 35043
Research Site
Vilinus, Lithuania, 08406
Research Site
Krakow, Poland, 30-663
United Kingdom
Research Site
London, United Kingdom, WC1N 3JH
Sponsors and Collaborators
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Study Director: MD Amgen

Additional Information:
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Responsible Party: Amgen Identifier: NCT02833857     History of Changes
Other Study ID Numbers: 20140336
2015-005051-28 ( EudraCT Number )
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 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.
Access Criteria: 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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amgen:
Secondary Hyperparathyroidism, chronic kidney disease, hemodialysis

Additional relevant MeSH terms:
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Kidney Diseases
Neoplasm Metastasis
Renal Insufficiency, Chronic
Hyperparathyroidism, Secondary
Urologic Diseases
Neoplastic Processes
Pathologic Processes
Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases