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

Completed · Phase 1

Conditions studied: Chronic Kidney Disease, Secondary Hyperparathyroidism

In brief

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.

Key facts

Study ID: NCT02833857
Run by: Amgen
People needed: 11
Starts: 2017-03-14
Expected to finish: 2018-10-31
Last updated by the study team: 2019-07-10

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Research Site — Los Angeles, California, United States
Research Site — Louisville, Kentucky, United States
Research Site — Kansas City, Missouri, United States
Research Site — Brussels, Belgium
Research Site — Ghent, Belgium
Research Site — Leuven, Belgium
Research Site — Cologne, Germany
Research Site — Hanover, Germany
Research Site — Heidelberg, Germany
Research Site — Marburg, Germany
Research Site — Vilinus, Lithuania
Research Site — Krakow, Poland
Research Site — London, United Kingdom

Full record on ClinicalTrials.gov

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