Trials / Completed
CompletedNCT03299244
Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)
A Multicenter, Multiple-dose, Active-controlled, Double-blind, Double-dummy Study to Compare the Therapeutic Efficacy and Safety of Oral Doses of Cinacalcet Hydrochloride With Intravenous Doses of Etelcalcetide (AMG 416) in Asian Hemodialysis Subjects With Secondary Hyperparathyroidism
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 637 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Etelcalcetide | Administered intravenously three times per week. |
| DRUG | Cinacalcet | Cinacalcet administered orally once a day. |
Timeline
- Start date
- 2018-05-15
- Primary completion
- 2020-04-08
- Completion
- 2020-04-08
- First posted
- 2017-10-03
- Last updated
- 2021-04-30
- Results posted
- 2021-04-30
Locations
90 sites across 6 countries: China, Hong Kong, India, Malaysia, South Korea, Taiwan
Source: ClinicalTrials.gov record NCT03299244. Inclusion in this directory is not an endorsement.