Trials / Completed
CompletedNCT03626948
SK-1403 Long-term Treatment Study; Long-term Study in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis
SK-1403 Long-term Treatment Study - Long-term Study in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis -
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 157 (actual)
- Sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the safety and efficacy of treatment with SK-1403 for 52 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 (52 weeks), with individual dose adjustment. |
Timeline
- Start date
- 2018-09-13
- Primary completion
- 2020-02-04
- Completion
- 2020-02-05
- First posted
- 2018-08-13
- Last updated
- 2020-03-09
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT03626948. Inclusion in this directory is not an endorsement.