NCT03969329

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

Phase 3, Single-arm, Open-label, Multidose, Titration, Pharmacokinetic, Pharmacodynamic, and Safety Study of Etelcalcetide in Children and Adolescents ≥ 2 to < 18 Years of Age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Secondary Hyperparathyroidism

Interventions

Type	Name	Description
DRUG	Etelcalcetide	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.

Timeline

• Start date: 2019-12-20
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2019-05-31
• Last updated: 2026-03-23

Locations

23 sites across 12 countries: Belgium, Czechia, France, Germany, Greece, Hungary, Italy, Lithuania, Poland, Portugal, Spain, United Kingdom

Regulatory

• FDA-regulated drug study