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 participate
Age range2 Years – 17 Years
SexALL
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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 Ca value greater than or equal to 9.0 mg/dL obtained from the central laboratory during screening.
* Dialysate Ca level greater than or equal to 2.5 mEq/L for at least 1 month prior to screening and throughout the duration of the trial.
* participant receiving active vitamin D sterols must have had no more than a maximum dose change of 50% within the 2 weeks prior to screening laboratory assessments, remain stable through enrollment, and be expected to maintain stable doses for the duration of the trial, except for adjustments allowed per protocol.
* p…
What they're measuring
1
Percent Change From Baseline in iPTH at Weeks 20 to 26