What is etelcalcetide studying for secondary hyperparathyroidism in children?

Etelcalcetide is being studied to understand its effects on secondary hyperparathyroidism in children and adolescents with chronic kidney disease on hemodialysis. Researchers want to evaluate how the drug works, its safety, and how the body processes it. The study is sponsored by Amgen and focuses on improving treatment options for this condition in young patients.

Who may be eligible for this secondary hyperparathyroidism clinical trial?

Children and adolescents aged 2 to under 18 years with chronic kidney disease and secondary hyperparathyroidism undergoing hemodialysis may be eligible. Both males and females can participate. Important factors include stable use of vitamin D sterols and phosphate binders, and specific blood calcium and hormone levels. 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 to and from the study sites may vary and are usually not covered. Participants and families should plan accordingly for any transportation costs.

Actively Recruiting

Phase 3

Age: 2Years - 17Years

All Genders

ID03969329

Phase 3 Study of Etelcalcetide in Children and Adolescents Aged 2 to Under 18 Years With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis

Led by Amgen · Updated on 2026-03-23

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the use of etelcalcetide to treat secondary hyperparathyroidism SHPT in children and adolescents aged 2 to under 18 years who have chronic kidney disease CKD and are on hemodialysis. This phase 3 study aims to assess the drugs effectiveness, safety, how it is processed by the body pharmacokinetics, and how it affects the body pharmacodynamics in this pediatric population. Participants will receive etelcalcetide alongside their standard care. The treatment involves multiple doses with titration to find the right dosage. The study is open-label and single-arm, meaning all participants receive the medication and are monitored over time. The trial includes treatment periods lasting up to 31 weeks. During the study, participants will undergo regular assessments including blood tests to measure changes in parathyroid hormone levels, calcium, and phosphorus. Researchers will monitor drug levels in the blood before and after dialysis sessions, track any side effects, and evaluate safety. The main outcome is the percent change in intact parathyroid hormone from baseline between weeks 20 to 26. The total participation time varies but includes ongoing monitoring throughout the treatment period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 2Years - 17Years

All Genders

Eligibility Criteria

You may qualify if you...

Participant's legally acceptable representative has provided informed consent and the participant has given assent as per local regulations.
Male or female participants aged 2 to under 18 years at enrollment.
Targeted dry weight of at least 7 kg at screening.
Diagnosed with chronic kidney disease and secondary hyperparathyroidism undergoing hemodialysis or hemodiafiltration three or four times weekly for at least 1 month.
Mean of two consecutive intact parathyroid hormone (iPTH) values greater than 300 pg/mL during screening.
Serum corrected calcium level of 9.0 mg/dL or higher at screening.
Dialysate calcium level of at least 2.5 mEq/L for one month prior to screening and throughout the trial.
Stable doses of active vitamin D sterols, phosphate binders, and calcium supplements with no more than 50% dose changes within 2 weeks before screening and expected stability during the trial.
Secondary hyperparathyroidism not caused by vitamin D deficiency per investigator assessment.

You will not qualify if you...

History of congenital long QT syndrome, advanced heart block, ventricular tachyarrhythmias, symptomatic ventricular dysrhythmias, or prolonged QT interval conditions.
Planned or recent parathyroidectomy or kidney transplant during the trial period.
Current or recent malignancy except non-melanoma skin cancer within 5 years.
Use of medications that prolong QTc interval unless approved with monitoring.
Recent use of cinacalcet or etelcalcetide within specified timeframes before screening.
Use of herbal medicines, vitamins, or supplements within 30 days prior to enrollment without review.
Participation in another investigational drug or device trial within 30 days before enrollment.
Significant laboratory abnormalities including elevated liver enzymes or prolonged QT interval.
New or worsening seizure disorder within 3 months prior to screening.
Female participants who are pregnant, breastfeeding, or unwilling to use effective contraception during and after treatment.
Known sensitivity to etelcalcetide or its components.
Inability to complete trial visits or comply with procedures.
History of unstable chronic heart failure within 1 year prior to screening.
Anemia preventing safe blood draws.
Previous participation in this trial or prior treatment with etelcalcetide as specified.

Research Team

Amgen Call Center

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Phase 3 Study of Etelcalcetide in Children and Adolescents Aged 2 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