NCT02833857

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2017

Geographic Reach
6 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 14, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

March 14, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
8 months until next milestone

Results Posted

Study results publicly available

July 10, 2019

Completed
Last Updated

July 10, 2019

Status Verified

April 1, 2019

Enrollment Period

1.6 years

First QC Date

June 9, 2016

Results QC Date

April 23, 2019

Last Update Submit

April 23, 2019

Conditions

Chronic Kidney Disease, Secondary Hyperparathyroidism

Keywords

Secondary Hyperparathyroidism, chronic kidney disease, hemodialysis

Outcome Measures

Primary Outcomes (13)

  • Common Treatment-emergent Adverse Events

    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.

    30 days

  • Change From Baseline in Serum Corrected Calcium Concentration Over Time

    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 \[g/L\]).

    Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)

  • Change From Baseline in Serum Phosphorus Concentration at End of Study

    Baseline and day 30 (end of study)

  • Change From Baseline in Serum Potassium Concentration at End of Study

    Baseline and day 30 (end of study)

  • Change From Baseline in Intact Parathyroid Hormone (iPTH) Levels Over Time

    Baseline and day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)

  • Change From Baseline in Heart Rate at End of Study

    Baseline and day 30 (end of study)

  • Change From Baseline in Temperature at End of Study

    Baseline and day 30 (end of study)

  • Change From Baseline in Blood Pressure at End of Study

    Baseline and day 30 (end of study)

  • Change From Baseline in PR Interval at End of Study

    Baseline and day 30 (end of study)

  • Change From Baseline in QRS Interval at End of Study

    Baseline and day 30 (end of study)

  • Change From Baseline in QT Interval at End of Study

    Baseline and day 30 (end of study)

  • Change From Baseline in Corrected (Bazett) QT Interval at End of Study

    Baseline and day 30 (end of study)

  • Change From Baseline in Corrected (Fridericia) QT Interval at End of Study

    Baseline and day 30 (end of study)

Secondary Outcomes (9)

  • Change From Baseline in Serum Total Calcium Concentration

    Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)

  • Change From Baseline in Serum Ionized Calcium Concentration

    Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)

  • Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide

    10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose

  • Time to Maximum Concentration (Tmax) of Etelcalcetide

    10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose

  • Area Under the Plasma Etelcalcetide Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast)

    10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose

  • +4 more secondary outcomes

Study Arms (1)

Etelcalcetide

EXPERIMENTAL

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

Interventions

EtelcalcetideDRUG

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.

Also known as: AMG 416, Parsabiv
Etelcalcetide

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Research Site

Los Angeles, California, 90095, United States

Location

Research Site

Louisville, Kentucky, 40202, United States

Location

Research Site

Kansas City, Missouri, 64108, United States

Location

Research Site

Brussels, 1020, Belgium

Location

Research Site

Ghent, 9000, Belgium

Location

Research Site

Leuven, 3000, Belgium

Location

Research Site

Cologne, 50937, Germany

Location

Research Site

Hanover, 30625, Germany

Location

Research Site

Heidelberg, 69120, Germany

Location

Research Site

Marburg, 35043, Germany

Location

Research Site

Vilinus, 08406, Lithuania

Location

Research Site

Krakow, 30-663, Poland

Location

Research Site

London, WC1N 3JH, United Kingdom

Location

Related Publications (1)

  • Sohn W, Salusky IB, Schmitt CP, Taylan C, Walle JV, Ngang J, Yan L, Kroenke M, Warady BA. Phase 1, single-dose study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of etelcalcetide in pediatric patients with secondary hyperparathyroidism receiving hemodialysis. Pediatr Nephrol. 2021 Jan;36(1):133-142. doi: 10.1007/s00467-020-04599-z. Epub 2020 Jul 9.

    PMID: 32647975DERIVED

Related Links

MeSH Terms

Conditions

Renal Insufficiency, ChronicHyperparathyroidism, Secondary

Interventions

etelcalcetide hydrochloride

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Results Point of Contact

Title
Study Director
Organization
Amgen Inc.
medinfo@amgen.com
866-572-6436

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2016

First Posted

July 14, 2016

Study Start

March 14, 2017

Primary Completion

October 31, 2018

Study Completion

October 31, 2018

Last Updated

July 10, 2019

Results First Posted

July 10, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will share

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, 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.
More information

Locations

PL(1)GB(1)US(3)DE(4)LI(1)BE(3)