Trial Summary
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.
Sponsor: Amgen
Participants: ALL
Start: 2019-12-20
Completion: 2027-06-30
Min Age: 2 Years
Max Age: 17 Years
Eligibility Criteria
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…
Data from ClinicalTrials.gov. Always verify on the primary source before clinical use.