ClinicaliQ Trial Snapshot
- A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis — Recruiting • Phase III • Respiratory / COPD / Asthma • NCT03969329.
- 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.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
- : * 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…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.