Belen De Escobar

Researchers are evaluating etelcalcetide in children aged 28 days to under 18 years who have secondary hyperparathyroidism (SHPT) and chronic kidney disease (CKD) while on hemodialysis. SHPT is a serious condition that develops early in CKD and worsens as kidney function declines, leading to bone problems, growth issues, and higher cardiovascular risks in children on dialysis. Current treatments like vitamin D sterols can sometimes worsen complications, so this phase 3 trial aims to assess etelcalcetide's safety and effectiveness in this pediatric population, building on its approval and use in adults with SHPT on hemodialysis. The study compares etelcalcetide treatment to standard care, which may include vitamin D sterols, calcium supplements, and phosphate binders. Etelcalcetide is given as a drug to control intact parathyroid hormone (iPTH), calcium, and phosphorus levels. The trial is randomized, open-label, and controlled, with multiple dosing to evaluate efficacy, safety, and related pharmacokinetics and pharmacodynamics. Participants continue on their hemodialysis regimen with stable dialysate calcium levels throughout the trial. Participants will have screenings and assessments including laboratory tests for iPTH, calcium, and phosphorus levels, as well as ECG monitoring and other safety evaluations. The primary outcomes measure the percentage of participants achieving at least a 30% reduction in mean iPTH from baseline during weeks 20 to 27. The study monitors participants closely for adverse effects and treatment response over the trial period to gather critical pediatric data on etelcalcetide's use in this vulnerable group.