Trials / Completed
CompletedNCT03801980
Phase 3 Study of SK-1403
Phase 3 Study of SK-1403 ; Double-blinded Parallel Group in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 153 (actual)
- Sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the efficacy and safety of treatment with SK-1403 for 24 weeks in patients with secondary hyperparathyroidism on maintenance hemodialysis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SK-1403 | Patients receive SK-1403 three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (24 weeks), with individual dose adjustment. |
| DRUG | Placebo | Patients receive Placebo three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (24 weeks), with individual dose adjustment. |
Timeline
- Start date
- 2019-01-21
- Primary completion
- 2019-12-17
- Completion
- 2019-12-21
- First posted
- 2019-01-14
- Last updated
- 2020-03-09
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT03801980. Inclusion in this directory is not an endorsement.