A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Haemodialysis

• Status: Completed
• Trial end date: 2018-10-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a study to evaluate the safety and pharmacokinetics in pediatric patients with secondary hyperparathyroidism receiving a single dose of etelcalcetide at the end of hemodialysis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen

Criteria

Inclusion Criteria:

• Subject's parent has provided informed consent and subject has provided assent

• Children Age 2 to less than 18 years

• Diagnosed with chronic kidney disease

• Diagnosed with secondary hyperparathyroidism receiving hemodialysis,

• Weighing at least 7 kg

• Laboratory results within specified range.

Exclusion Criteria:

• Currently receiving treatment in another investigation device or drug study

• Subject has received cinacalcet therapy within 30 days

• History of prolongation QT interval

• Subject is taking any medications that are on the QT prolongation medication list

• Electrocardiograph (ECG) measurements within specified range.