RecruitingRecruiting
LUPKYNIS Drug-use Results Survey
NCT07053891 · Otsuka Pharmaceutical Co., Ltd.
In plain English
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About this study
The purpose of this study is to survey the safety of LUPKYNIS in patients with lupus nephritis under actual use conditions. In addition, information on efficacy will be collected.
Eligibility criteria
Inclusion Criteria:
* Patients who are newly starting administration of LUPKYNIS for lupus nephritis
Exclusion Criteria:
\-
Study design
Enrollment target: 400 participants
Age groups: child, adult, older_adult
Timeline
Starts: 2025-09-17
Estimated completion: 2032-06-30
Last updated: 2025-09-19
Interventions
Drug: Voclosporin (LUPKYNIS)
Primary outcomes
- • Safety Information (Number of Adverse Event) (3 years from the initiation of LUPKYNIS treatment)
- • Safety Information (Types of Special Situations and the Number of Corresponding Cases) (3 years from the initiation of LUPKYNIS treatment)
- • Safety Information (Number of off-Label Use) (3 years from the initiation of LUPKYNIS treatment)
Sponsor
Otsuka Pharmaceutical Co., Ltd. · industry
Contacts & investigators
ContactPharmacovigilance Department Otsuka Pharmaceutical Co., Ltd · contact · komaniwa.satoshi@otsuka.jp · +81-6-6943-7722
All locations (1)
Pharmacovigilance DepartmentRecruiting
Osaka, Osaka, Japan