Trials / Completed
CompletedNCT03822507
Study of KHK7580 in Subjects With Secondary Hyperparathyroidism in Asia
A Phase 3, Randomized, Double-Blind, Intra-Subject Dose-Adjustment, Parallel-Group Study of KHK7580 and Cinacalcet Hydrochloride in Subjects With Secondary Hyperparathyroidism Receiving Hemodialysis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 404 (actual)
- Sponsor
- Kyowa Kirin Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and the safety of KHK7580 orally administered once daily for 52 weeks compared to cinacalcet hydrochloride as an active control in subjects with secondary hyperparathyroidism receiving hemodialysis in China, Korea, Hong Kong and Taiwan.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KHK7580 | oral administration |
| DRUG | Cinacalcet Hydrochloride | oral administration |
Timeline
- Start date
- 2019-04-09
- Primary completion
- 2021-09-23
- Completion
- 2021-09-23
- First posted
- 2019-01-30
- Last updated
- 2022-04-25
Locations
34 sites across 4 countries: China, Hong Kong, South Korea, Taiwan
Source: ClinicalTrials.gov record NCT03822507. Inclusion in this directory is not an endorsement.