Warady BA, et al. - In this randomized phase 3 study, with double-blind and open-label phases, researchers tested cinacalcet as a treatment option in children with secondary hyperparathyroidism (SHPT) receiving dialysis. Patients aged 6– < 18 years were considered eligible and were randomly administered cinacalcet (starting dose ≤ 0.20 mg/kg) or placebo. A total of 43 patients (cinacalcet, n = 22; placebo, n = 21) were included in the double-blind phase. After a 14-month clinical hold, the study was terminated. Findings revealed ≥ 1 treatment-emergent adverse event in 82% of patients on cinacalcet and 86% on placebo; the most commonly documented were vomiting (32%, 24%, respectively), hypocalcemia (23%, 19%), nausea (18%, 14%), and hypertension (14%, 24%). Before the hold, the primary endpoint (≥ 30% reduction from baseline in mean intact parathyroid hormone) was achieved by 12 patients (55%) on cinacalcet and four (19%) on placebo, and 27% and 24%, respectively, achieved iPTH ≤ 300 pg/mL. For changes for total serum calcium, phosphorus, and calcium phosphorus product (Ca × P), the observed between-group differences (95% CI) in percentage were − 4% (− 9 to 1%), − 6% (− 21 to 8%), and − 10% (− 23 to 3%). Overall, even with the early termination, the effectiveness and safety of cinacalcet in children with SHPT on dialysis were consistent with adult observations.