Trials / Completed
CompletedNCT03226171
Dose Adjustment Trial of SK-1403 in Hemodialysis Patients With Secondary Hyperparathyroidism
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 58 (actual)
- Sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years – 79 Years
- Healthy volunteers
- Not accepted
Summary
This study is conducted to assess the efficacy and safety of SK-1403 in Hemodialysis Patients with Secondary Hyperparathyroidism. In the first treatment period, the efficacy of SK-1403 is assessed after 18 weeks of treatment with SK-1403 individually dose-adjusted . Safety is also assessed during this period. Patients who completed the first treatment period proceed to the second treatment period and receive the treatment with SK-1403 for 34 weeks. Efficacy and safety of SK-1403 are also assessed during this period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dose-adjusted SK-1403 | SK-1403 is to be administered to patients for the whole treatment periods (52 weeks), with individual dose adjustment |
Timeline
- Start date
- 2017-06-20
- Primary completion
- 2018-09-11
- Completion
- 2018-09-11
- First posted
- 2017-07-21
- Last updated
- 2019-03-15
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT03226171. Inclusion in this directory is not an endorsement.