Health Trials

A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis

ConditionSecondary Hyperparathyroidism
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-17
SponsorAmgen

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrhythmia's, history of symptomatic ventricular dysrhythmias Torsades de Pointes 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 enrollment.

Trial design

Design model

Single group

Treatments tested in this trial

  • Etelcalcetide

    Drug

    Etelcalcetide has been shown to be safe and efficacious in treating adult CKD patients with SHPT by simultaneously controlling iPTH, calcium (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.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: EtelcalcetideExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percent Change From Baseline in iPTH at Weeks 20 to 26

To evaluate the efficacy of etelcalcetide in reducing the iPTH level in children ages equal to or greater than 2 to less than 18 years with SHPT receiving maintenance hemodialysis.

Time frame
Week 20 to 26

Secondary outcomes

1

Number of Participants Who Achieve a >30% Reduction From Baseline in Mean iPTH

To evaluate the efficacy of etelcalcetide.

Time frame
Week 20 to 26
2

Percent Change From Baseline in Corrected Total Serum Ca and Serum Phosphorus

To characterize change in laboratory markers of chronic kidney disease.

Time frame
Week 20 to 26
3

Proportion of Participants Achieving Corrected Serum Ca Levels Less Than 8.0 mg/dL (2.0 mmol/L)

To characterize the safety of etelcalcetide treatment based on laboratory values.

Time frame
During the treatment period (up to 31 weeks)
4

Proportion of Participants with Hypocalcemia

To characterize the safety of etelcalcetide treatment based on laboratory values. Hypocalcemia is defined as corrected serum calcium levels less than 8.4 mg/dL.

Time frame
During the treatment period (up to 31 weeks)

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Childrens Hospital, Affiliate of Vilnius University Hospital Santaros KlinikosTerminated08406, VilinusLithuaniaLithuania

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amgen

Lead sponsor

Source ClinicalTrials.gov
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