A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis
ConditionSecondary Hyperparathyroidism
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-17
SponsorAmgen
About this trial
Assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in pediatric participants between ≥ 2 to \< 18 years of age, with chronic kidney disease (CKD) on hemodialysis.
Eligibility criteria
Qualifiers
Participant's legally acceptable representative has provided informed consent when the participant is legally too young to provide informed consent and the participant has provided written assent based on local regulations and/or guidelines prior to any trial-specific activities/procedures being initiated.
Male or female participants greater than or equal to 2 to less than 18 years of age at the time of enrollment.
Targeted dry weight greater than or equal to 7 kg at the time of screening Week -1.
Diagnosed with CKD and SHPT undergoing hemodialysis/hemodiafiltration TIW or four times a week (QIW) at the time of screening greater than or equal to 1 month.
Disqualifiers
History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrhythmia's, history of symptomatic ventricular dysrhythmias Torsades de Pointes or other conditions associated with prolonged QT interval.
Anticipated or scheduled parathyroidectomy during the trial period.
Anticipated or scheduled kidney transplant during the trial period.
Participant has received a parathyroidectomy within 6 months prior to enrollment.
Trial design
Treatments tested in this trial
- Etelcalcetide
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov