A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age0-18
SponsorAmgen
About this trial
This is a phase 3 trial of etelcalcetide in pediatric participants with secondary hyperparathyroidism (SHPT) and chronic kidney disease (CKD) on hemodialysis.
Eligibility criteria
Qualifiers
Age of 28 days < 18 years.
Dry weight ≥ 7 kg during screening.
Diagnosed with CKD and SHPT undergoing hemodialysis at the time of screening.
Diagnosis of SHPT with the mean of the 2 consecutive central laboratory iPTH values ≥ 300 pg/mL (32 pmol/L) during screening, on separate days and within 2 weeks of enrolment.
Disqualifiers
History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrhythmia's or other conditions associated with prolonged QT interval.
Anticipated or scheduled parathyroidectomy during the trial period.
Anticipated or scheduled kidney transplant during the trial period.
Participant has received a parathyroidectomy within 6 months prior to randomization.
Trial design
Treatments tested in this trial
- Etelcalcetide
- Standard of Care
Treatment groups
56 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov