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Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient.
Status
Recruiting
Phase
PHASE3
NCT ID
NCT03969329

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.

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