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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Etelcalcetide
DrugEtelcalcetide has been shown to be safe and efficacious in treating adult CKD patients with SHPT by simultaneously controlling iPTH, Ca, and phosphorus and has recently been approved for use in adult patients with SHPT treated with hemodialysis in both the United States and Europe
Standard of Care
Other interventionStandard of care, which can include therapy with vitamin D sterols, Ca supplementation, and/or phosphate binders
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: EtelcalcetideExperimental treatment 2 interventions
Group B: Standard of CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Participants Achieving a ≥ 30% Reduction from Baseline in Mean iPTH During the Efficacy Assessment Period (EAP)
Achievement of at least a 30% reduction from baseline in mean iPTH during the EAP (defined as weeks 20 through 27).
Time frame
Baseline and Weeks 20-272
Percentage Change from Baseline in Mean iPTH During the EAP
Percent Change from Baseline in Mean iPTH During EAP (defined as weeks 20 through 27).
Time frame
Baseline and Weeks 20-27Secondary outcomes
1
Maximum Serum Concentration (Cmax) of Etelcalcetide
Cmax will be collected and reported for the etelcalcetide arm only.
Time frame
10-30 minutes post dose on Day 1 and 10-30 minutes post dose on Weeks 5, 9, 13, 17, and 212
Minimum Serum Concentration (Cmin) of Etelcalcetide
Cmin will be collected and reported for the etelcalcetide arm only.
Time frame
10-30 minutes post dose on Day 1 and 10-30 minutes post dose on Weeks 5, 9, 13, 17, and 213
Number of Participants who Experienced Adverse Events (AEs)
To characterize the safety of etelcalcetide treatment based on adverse events. Nature, frequency, severity, and relationship to treatment of all adverse events, including those of special interest reported during the trial.
Time frame
Day 1 to 30 days after last dose of etelcalcetide (up to approximately 30 weeks)4
Frequency of Hypocalcemia
Occurrence of hypocalcemia at any point in time, assessed by serum chemistry.
Time frame
Up to approximately 30 Weeks Source ClinicalTrials.gov