What is etelcalcetide studying for secondary hyperparathyroidism in children with chronic kidney disease?

Etelcalcetide is being studied to see how it affects hormone and mineral levels in children with secondary hyperparathyroidism on hemodialysis. This trial aims to understand its safety and how well it works in the pediatric population. The research is sponsored by Amgen to address important treatment needs for these children.

Who may be eligible for this secondary hyperparathyroidism clinical trial?

Children aged 28 days to under 18 years with chronic kidney disease on hemodialysis and diagnosed with secondary hyperparathyroidism may be eligible. Both boys and girls can participate. Important factors include stable doses of related medications and no recent use of similar treatments. Please review eligibility criteria for more details.

Is there any cost to participate in this secondary hyperparathyroidism clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants can expect to receive all necessary treatments and assessments without charge.

Actively Recruiting

Phase 3

Age: 0Years - 18Years

All Genders

ID03633708

Phase 3 Study of Etelcalcetide for Children Aged 28 Days to Under 18 Years With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis

Led by Amgen · Updated on 2026-02-27

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating etelcalcetide in children with secondary hyperparathyroidism SHPT who also have chronic kidney disease CKD and are receiving hemodialysis. SHPT is a serious condition that develops early in CKD and can cause bone and growth problems as well as increased cardiovascular risks in children on dialysis. This phase 3 trial aims to provide important safety and efficacy data for etelcalcetide in pediatric patients aged 28 days to under 18 years, addressing the limitations of current treatments like vitamin D sterols. Participants are randomly assigned in a 51 ratio to receive either etelcalcetide along with standard care or standard care alone. The standard care may include treatments such as vitamin D sterols, calcium supplements, or phosphate binders. The study involves multiple doses of etelcalcetide, with assessments conducted over weeks to monitor its effects on parathyroid hormone levels and mineral balance. During the study, participants will undergo regular evaluations including blood tests to measure intact parathyroid hormone, calcium, and phosphorus levels. Researchers will also monitor safety by tracking adverse events and changes in vital signs, growth, and development stages. The primary outcome focuses on the percentage of participants achieving a significant reduction in hormone levels over weeks 20 to 27. The trial includes careful monitoring throughout treatment and up to approximately 30 weeks after the last dose.

CONDITIONS

Brief Title

A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis

Who Can Participate

Age: 0Years - 18Years

All Genders

Eligibility Criteria

You may qualify if you...

Age between 28 days and under 18 years
Dry weight of 7 kg or more at screening
Diagnosed with chronic kidney disease and secondary hyperparathyroidism undergoing hemodialysis at screening
Mean intact parathyroid hormone (iPTH) levels of 300 pg/mL or higher from two tests within 2 weeks before enrollment
Serum corrected calcium of 9.0 mg/dL or higher for participants 2 years or older, or 9.6 mg/dL or higher for those between 28 days and under 2 years
Dialysate calcium level of 2.5 mEq/L or higher for at least 4 weeks before and during the trial
Stable doses of vitamin D sterols, phosphate binders, and calcium supplements within 2 weeks before screening
Secondary hyperparathyroidism not caused by vitamin D deficiency, as assessed by the investigator

You will not qualify if you...

History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrhythmias, or other prolonged QT conditions
Planned parathyroidectomy or kidney transplant during the trial
Parathyroidectomy within 6 months before randomization
History of malignancy within 5 years, except certain skin or in situ cancers
Use of medications that may prolong QT interval unless approved with extra monitoring
Use of cinacalcet within 30 days before screening or etelcalcetide within 6 months before screening
Use of herbal medicines, vitamins, or supplements within 30 days before randomization without review and approval
Use of non-approved medications within 14 days before randomization without review and approval
Participation in another investigational drug or device trial within 30 days before enrollment
Significant lab abnormalities including liver enzymes over twice normal limits
Corrected QT interval over 500 ms or 450 to 500 ms without special approval
Clinically significant ECG abnormalities posing risk or interfering with the trial
New or worsening seizure disorder within 60 days before enrollment
Premature birth under 36 weeks gestational age for participants aged 28 days to 6 months
Female participants who are pregnant, breastfeeding, or unwilling to use effective contraception
Known sensitivity to etelcalcetide or its ingredients
Inability to complete all trial visits or comply with procedures
Other significant medical conditions judged by the investigator to pose risk or interfere with the trial
Previous participation in this trial

Research Team

Amgen Call Center

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Phase 3 Study of Etelcalcetide for Children Aged 28 Days to Under 18 Years With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria