NCT03633708

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

Phase 3, Randomized, Open-label, Controlled, Multiple Dose, Efficacy, Safety, Pharmacokinetic, and Pharmacodynamic Study of Etelcalcetide in Pediatric Subjects 28 Days to < 18 Years of Age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 0 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 3 trial of etelcalcetide in pediatric participants with secondary hyperparathyroidism (SHPT) and chronic kidney disease (CKD) on hemodialysis.

Detailed description

SHPT is a common and serious co-morbidity that develops relatively early in the course of CKD, worsens with declining kidney function, and is associated with serious complications in children on dialysis. Children on dialysis experience a wide spectrum of bone abnormalities and growth retardation, in addition to increased risk for cardiovascular morbidity and mortality that manifests early in their adulthood. Traditional therapies for SHPT (eg, vitamin D sterols) are widely used in the pediatric dialysis population, and have the potential to aggravate complications of the disease by increasing serum calcium (Ca), serum phosphorus, and serum Ca times serum phosphorus product. Etelcalcetide has been shown to be safe and efficacious in treating adult CKD patients with SHPT by simultaneously controlling intact parathyroid hormone (iPTH), 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. Although no previous trials have been conducted in pediatric patients with etelcalcetide (one single dose pharmacokinetic \[PK\] trial is currently ongoing), Amgen anticipates minimal to moderate risk with a possibility of direct benefit to the pediatric participants (age 28 days to 18 years) in this trial. The burden of complications of SHPT in the pediatric dialysis population and the limitations of current standard therapy, underscore the need for trials of etelcalcetide in these patients to address this unmet medical need and inform the pediatric nephrology community of the potential use of etelcalcetide in children on hemodialysis with critical safety and efficacy data.

Conditions

• Secondary Hyperparathyroidism
• Chronic Kidney Disease

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, 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
OTHER	Standard of Care	Standard of care, which can include therapy with vitamin D sterols, Ca supplementation, and/or phosphate binders

Timeline

• Start date: 2019-04-29
• Primary completion: 2029-01-31
• Completion: 2029-01-31
• First posted: 2018-08-16
• Last updated: 2026-02-27

Locations

43 sites across 10 countries: United States, Argentina, India, Malaysia, Russia, Singapore, South Korea, Taiwan, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study