Clinical trial NCT02833857: A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Haemodialysis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Kidney Disease, Secondary Hyperparathyroidism
Keywords: Secondary Hyperparathyroidism, chronic kidney disease, hemodialysis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2016-07-14
Enrollment: 11
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Common Treatment-emergent Adverse Events
timeFrame: 30 days
measure: Change From Baseline in Serum Corrected Calcium Concentration Over Time
timeFrame: Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)
measure: Change From Baseline in Serum Phosphorus Concentration at End of Study
timeFrame: Baseline and day 30 (end of study)
measure: Change From Baseline in Serum Potassium Concentration at End of Study
timeFrame: Baseline and day 30 (end of study)
measure: Change From Baseline in Intact Parathyroid Hormone (iPTH) Levels Over Time
timeFrame: Baseline and day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)
measure: Change From Baseline in Heart Rate at End of Study
timeFrame: Baseline and day 30 (end of study)
measure: Change From Baseline in Temperature at End of Study
timeFrame: Baseline and day 30 (end of study)
measure: Change From Baseline in Blood Pressure at End of Study
timeFrame: Baseline and day 30 (end of study)
measure: Change From Baseline in PR Interval at End of Study
timeFrame: Baseline and day 30 (end of study)
measure: Change From Baseline in QRS Interval at End of Study
timeFrame: Baseline and day 30 (end of study)
measure: Change From Baseline in QT Interval at End of Study
timeFrame: Baseline and day 30 (end of study)
measure: Change From Baseline in Corrected (Bazett) QT Interval at End of Study
timeFrame: Baseline and day 30 (end of study)
measure: Change From Baseline in Corrected (Fridericia) QT Interval at End of Study
timeFrame: Baseline and day 30 (end of study)
Secondary outcomes:
measure: Change From Baseline in Serum Total Calcium Concentration
timeFrame: Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)
measure: Change From Baseline in Serum Ionized Calcium Concentration
timeFrame: Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)
measure: Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide
timeFrame: 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose
measure: Time to Maximum Concentration (Tmax) of Etelcalcetide
timeFrame: 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose
measure: Area Under the Plasma Etelcalcetide Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast)
timeFrame: 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose
measure: Area Under the Plasma Etelcalcetide Concentration-Time Curve From Time Zero Infinity (AUCinf)
timeFrame: 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose
measure: Terminal Half-life (T1/2,z) of Etelcalcetide
timeFrame: 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose
measure: Number of Participants Who Developed Anti-etelcalcetide Binding Antibodies
timeFrame: Baseline and day 30
measure: Number of Participants With Treatment-emergent Adverse Events
timeFrame: 30 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Louisville
country: United States
facility: Research Site
state: Kentucky
city: Kansas City
country: United States
facility: Research Site
state: Missouri
city: Bruxelles
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Köln
country: Germany
facility: Research Site
city: Marburg
country: Germany
facility: Research Site
city: Vilinus
country: Lithuania
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.