A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis
25 March 2026
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🅇 This trial is currently recruiting participants in the UK
Speak to your GP or specialist first. They can help you understand if you might be eligible and what taking part would involve.
🅇 This trial is currently recruiting volunteers
If you think you might be eligible, speak to your GP or specialist about this trial before applying.
Status
Recruiting
Phase
PHASE3
Participants
ALL
Age Range
2 Years – 17 Years
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.
Who Can Join?
Inclusion Criteria: * 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. * Diagnosis of SHPT with the mean of the 2 consecutive central laboratory iPTH values greater than 300 pg/mL during screening, on separate days and within 2 weeks of enrollment obtained from the central laboratory during screening. * Serum corrected…
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