Belen De Escobar

Researchers are evaluating etelcalcetide in children with secondary hyperparathyroidism SHPT who also have chronic kidney disease CKD and are receiving hemodialysis. SHPT is a serious condition that develops early in CKD and can cause bone and growth problems as well as increased cardiovascular risks in children on dialysis. This phase 3 trial aims to provide important safety and efficacy data for etelcalcetide in pediatric patients aged 28 days to under 18 years, addressing the limitations of current treatments like vitamin D sterols. Participants are randomly assigned in a 51 ratio to receive either etelcalcetide along with standard care or standard care alone. The standard care may include treatments such as vitamin D sterols, calcium supplements, or phosphate binders. The study involves multiple doses of etelcalcetide, with assessments conducted over weeks to monitor its effects on parathyroid hormone levels and mineral balance. During the study, participants will undergo regular evaluations including blood tests to measure intact parathyroid hormone, calcium, and phosphorus levels. Researchers will also monitor safety by tracking adverse events and changes in vital signs, growth, and development stages. The primary outcome focuses on the percentage of participants achieving a significant reduction in hormone levels over weeks 20 to 27. The trial includes careful monitoring throughout treatment and up to approximately 30 weeks after the last dose.