Etelcalcetide for Secondary Hyperparathyroidism in Children

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

Recruiting Phase 3 Interventional Study
Secondary Hyperparathyroidism
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
2 – 17
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
Amgen · Industry
Who this trial is looking for

This trial is looking for children aged 2 to under 18 who have secondary hyperparathyroidism and are on hemodialysis. Participants will receive etelcalcetide to see how well it works and its safety in treating their condition.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am aged between 2 to 18 years old.
  • I have chronic kidney disease with secondary hyperparathyroidism.
  • I am currently undergoing hemodialysis.
  • I weigh at least 7 kg.
  • I have a mean iPTH level greater than 300 pg/mL.
  • My serum corrected calcium level is at least 9.0 mg/dL.
  • I have been stable on my current medications related to my condition.

You may not be able to join if

  • I have a history of certain heart problems.
  • I am scheduled for a kidney transplant or parathyroid surgery during the trial.
  • I have had certain types of cancer recently.
  • I have significant heart rhythm issues.
  • I have taken etelcalcetide or cinacalcet within the last 6 months.
  • I have had a new or worsening seizure disorder in the past 3 months.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

Check Your Eligibility
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.

Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
Inclusion Criteria: * 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 activiti…
Contacts

Amgen Call Center

866-572-6436

medinfo@amgen.com

CONTACT