Trials / Completed
CompletedNCT02833857
A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Haemodialysis
An Open-label, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Etelcalcetide (AMG 416) in Paediatric Subjects Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Maintenance Haemodialysis
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 2 Years – 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Etelcalcetide | A single IV-bolus dose of 0.035 mg/kg etelcalcetide into the venous line of the dialysis circuit at the end of a hemodialysis session. |
Timeline
- Start date
- 2017-03-14
- Primary completion
- 2018-10-31
- Completion
- 2018-10-31
- First posted
- 2016-07-14
- Last updated
- 2019-07-10
- Results posted
- 2019-07-10
Locations
13 sites across 6 countries: United States, Belgium, Germany, Lithuania, Poland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02833857. Inclusion in this directory is not an endorsement.