Trials / Completed
CompletedNCT02549391
Phase 3 Study of KHK7580
Phase 3 Study of KHK7580 (A 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 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 634 (actual)
- Sponsor
- Kyowa Kirin Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of KHK7580 orally administered once daily for 30 weeks in subjects with secondary hyperparathyroidism (SHPT) receiving hemodialysis in a randomized, double-blind, intra-subject dose-adjustment, parallel-group design with cinacalcet hydrochloride as an active control.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KHK7580 | Oral administration |
| DRUG | KRN1493 | Oral administration |
Timeline
- Start date
- 2015-09-01
- Primary completion
- 2016-11-01
- Completion
- 2016-11-01
- First posted
- 2015-09-15
- Last updated
- 2017-03-24
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT02549391. Inclusion in this directory is not an endorsement.