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

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ClinicalTrials.gov Identifier: NCT02833857
Recruitment Status : Completed
First Posted : July 14, 2016
Results First Posted : July 10, 2019
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
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: Etelcalcetide
Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Drug: Etelcalcetide
A single IV-bolus dose of 0.035 mg/kg etelcalcetide into the venous line of the dialysis circuit at the end of a hemodialysis session.
Other Names:
  • AMG 416
  • Parsabiv




Primary Outcome Measures :
  1. Common Treatment-emergent Adverse Events [ Time Frame: 30 days ]

    A treatment-emergent adverse event is any adverse event (AE) that begins or worsens after the initial dose of study drug (etelcalcetide) and up to 30 days after the last dose.

    Common adverse events were defined as adverse events occurring in at least 2 participants.

    The Medical Dictionary for Regulatory Activities (MedDRA) version 21.0 was used for coding all adverse events.


  2. Change From Baseline in Serum Corrected Calcium Concentration Over Time [ Time Frame: Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study) ]
    When albumin was less than 4.0 mg/dL, the calcium concentration was corrected according to the formula: cCa (mmol/L) = measured total serum calcium (mmol/L) + 0.02 (40 - serum albumin [g/L]).

  3. Change From Baseline in Serum Phosphorus Concentration at End of Study [ Time Frame: Baseline and day 30 (end of study) ]
  4. Change From Baseline in Serum Potassium Concentration at End of Study [ Time Frame: Baseline and day 30 (end of study) ]
  5. Change From Baseline in Intact Parathyroid Hormone (iPTH) Levels Over Time [ Time Frame: Baseline and day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study) ]
  6. Change From Baseline in Heart Rate at End of Study [ Time Frame: Baseline and day 30 (end of study) ]
  7. Change From Baseline in Temperature at End of Study [ Time Frame: Baseline and day 30 (end of study) ]
  8. Change From Baseline in Blood Pressure at End of Study [ Time Frame: Baseline and day 30 (end of study) ]
  9. Change From Baseline in PR Interval at End of Study [ Time Frame: Baseline and day 30 (end of study) ]
  10. Change From Baseline in QRS Interval at End of Study [ Time Frame: Baseline and day 30 (end of study) ]
  11. Change From Baseline in QT Interval at End of Study [ Time Frame: Baseline and day 30 (end of study) ]
  12. Change From Baseline in Corrected (Bazett) QT Interval at End of Study [ Time Frame: Baseline and day 30 (end of study) ]
  13. Change From Baseline in Corrected (Fridericia) QT Interval at End of Study [ Time Frame: Baseline and day 30 (end of study) ]

Secondary Outcome Measures :
  1. Change From Baseline in Serum Total Calcium Concentration [ Time Frame: Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study) ]
  2. Change From Baseline in Serum Ionized Calcium Concentration [ Time Frame: Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study) ]
  3. Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide [ Time Frame: 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose ]
    Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL.

  4. Time to Maximum Concentration (Tmax) of Etelcalcetide [ Time Frame: 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose ]
    Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL.

  5. Area Under the Plasma Etelcalcetide Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) [ Time Frame: 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose ]

    Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL.

    Area under the curve for plasma etelcalcetide from time zero to the last quantifiable concentration (AUClast) was estimated using the linear trapezoidal method.


  6. Area Under the Plasma Etelcalcetide Concentration-Time Curve From Time Zero Infinity (AUCinf) [ Time Frame: 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose ]

    Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL.

    Area under the concentration-time curve from time zero to infinite time (AUCinf) was estimated using the linear trapezoidal method.


  7. Terminal Half-life (T1/2,z) of Etelcalcetide [ Time Frame: 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose ]

    Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL.

    Terminal half life of plasma etelcalcetide (t1/2,z) was calculated as t1/2,z = ln(2)/λz, where λz is the first-order terminal rate constant estimated by linear regression of the terminal log-linear phase.


  8. Number of Participants Who Developed Anti-etelcalcetide Binding Antibodies [ Time Frame: Baseline and day 30 ]

    Samples were collected predose and at end of study (day 30) and tested for anti etelcalcetide binding antibodies using a validated immunoassay.

    Developing antibody binding was defined as participants who were binding antibody positive postbaseline with a negative result at baseline.


  9. Number of Participants With Treatment-emergent Adverse Events [ Time Frame: 30 days ]
    A treatment-emergent adverse event is any adverse event that begins or worsens after the initial dose of study drug (etelcalcetide) and up to 30 days after the last dose. The severity of each adverse event was graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 1 = Mild (asymptomatic or mild symptoms), Grade 2 = Moderate (minimal, local or noninvasive intervention indicated), Grade 3 = Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated, Grade 4 = Life-threatening consequences; urgent intervention indicated, and Grade 5 = Death related to AE.



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

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 medication list
  • Electrocardiograph (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 ClinicalTrials.gov identifier (NCT number): NCT02833857


Locations
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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
Belgium
Research Site
Bruxelles, Belgium, 1020
Research Site
Gent, Belgium, 9000
Research Site
Leuven, Belgium, 3000
Germany
Research Site
Hannover, Germany, 30625
Research Site
Heidelberg, Germany, 69120
Research Site
Köln, Germany, 50937
Research Site
Marburg, Germany, 35043
Lithuania
Research Site
Vilinus, Lithuania, 08406
Poland
Research Site
Krakow, Poland, 30-663
United Kingdom
Research Site
London, United Kingdom, WC1N 3JH
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
  Study Documents (Full-Text)

Documents provided by Amgen:
Study Protocol  [PDF] February 18, 2016
Statistical Analysis Plan  [PDF] June 9, 2016


Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02833857     History of Changes
Other Study ID Numbers: 20140336
2015-005051-28 ( EudraCT Number )
First Posted: July 14, 2016    Key Record Dates
Results First Posted: July 10, 2019
Last Update Posted: July 10, 2019
Last Verified: April 2019
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.
URL: https://www.amgen.com/datasharing

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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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Neoplasm Metastasis
Kidney Diseases
Renal Insufficiency, Chronic
Hyperparathyroidism
Hyperparathyroidism, Secondary
Urologic Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases