drugset / Trial / NCT03969329
A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis
NaSingle-groupOpen-labelTreatment
Summary
Assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in pediatric participants between ≥ 2 to \< 18 years of age, with chronic kidney disease (CKD) on hemodialysis.
Timeline
- Start
- 2019-12-20
- Primary completion
- 2027-06-30
- Completion
- 2027-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Etelcalcetide | Other / unclassified | 0.035 mg/kg | — |
| Subject | Etelcalcetide | Other / unclassified | 0.07 mg/kg | — |
| Subject | Etelcalcetide | Other / unclassified | 0.21 mg/kg | — |
| Subject | Etelcalcetide | Other / unclassified | 2.5 mg | — |
| Subject | Etelcalcetide | Other / unclassified | 5 mg | — |
| Subject | Etelcalcetide | Other / unclassified | 15 mg | — |