A Single-dose Study in Paediatric Subjects Aged 2 to Less Than 18 Years With (sHPT) Receiving Haemodialysis
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Endocrine |
| Therapuetic Areas: | Endocrinology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 2 - 17 |
| Updated: | 12/29/2018 |
| Start Date: | March 14, 2017 |
| End Date: | October 31, 2018 |
An Open-label, Single-dose Study to Evaluate Etelcalcetide (AMG 416) in Paediatric Subjects Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Maintenance Haemodialysis
This is a multicenter, open-label study to evaluate the safety and pharmacokinetics in
pediatric subjects with secondary hyperparathyroidism receiving a single dose of AMG 416 at
the end of hemodialysis.
pediatric subjects with secondary hyperparathyroidism receiving a single dose of AMG 416 at
the end of hemodialysis.
A Single-dose Study to Evaluate the Safety and Pharmacokinetics in Paediatric Subjects Aged 2
to less than 18 Years with (sHPT) Receiving Maintenance Haemodialysis
to less than 18 Years with (sHPT) Receiving Maintenance Haemodialysis
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 mediation list
- ECG measurements within specified range.
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