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

Amgen

Status and phase: Completed; Phase 1

Conditions: Chronic Kidney Disease, Secondary Hyperparathyroidism

Treatments: Drug: Etelcalcetide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02833857

20140336

2015-005051-28 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Etelcalcetide

Experimental group

Description:

Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.

Treatment:

Drug: Etelcalcetide