Paediatric Study with Etelcalcetide in Secondary Hyperparathyroidism
Research type
Research Study
Full 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
IRAS ID
209718
Contact name
Rukshana Shroff
Contact email
Sponsor organisation
Amgen Ltd
Eudract number
2015-005051-28
Duration of Study in the UK
1 years, 6 months, 31 days
Research summary
The purpose of this study is to find out more about etelcalcetide in children with secondary hyperparathyroidism (sHPT).
This study will see if etelcalcetide at half of the adult starting dose is safe and well tolerated in children and whether it causes any side effects. It will look at how much etelacalcetide is in the blood and how it effects the blood tests (eg, calcium and parathyroid hormone (PTH) levels).
A total of about 10 children are expected to participate in this study. This study will take place in approximately 16 centres in Belgium, Germany, Lithuania, Poland, UK and US.
Participants will be in this study for about 6 weeks, which includes a 2 week screening period and 4 weeks on study.
Participants will receive the investigational product 1 time after haemodialysis. Subsequent visits will be conducted to collect blood to determine the amount of investigational product in the blood over time, determine the effects of the investigational product, perform safety laboratory tests and determine the presence of antibodies.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
16/EE/0362
Date of REC Opinion
9 Nov 2016
REC opinion
Further Information Favourable Opinion