drugset / Trial / NCT03299244

Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)

NCT03299244

Phase 3 Completed 637 enrolled Amgen
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

EvaluationDrugModalityDoseRoute
Comparator Cinacalcet Other / unclassified 25 mg Oral
Subject Etelcalcetide Other / unclassified 5 mg Intravenous