drugset / Trial / NCT03299244
Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The primary objective is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum intact parathyroid hormone (PTH) levels by \> 30% from baseline among participants with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.
Timeline
- Start
- 2018-05-15
- Primary completion
- 2020-04-08
- Completion
- 2020-04-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cinacalcet | Other / unclassified | 25 mg | Oral |
| Subject | Etelcalcetide | Other / unclassified | 5 mg | Intravenous |