Survey of LUPKYNIS (voclosporin) use in lupus nephritis
LUPKYNIS Drug-use Results Survey
This survey will collect safety and effectiveness information about LUPKYNIS (voclosporin) in people who are newly starting treatment for lupus nephritis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | Otsuka Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Osaka, Osaka) |
| Trial ID | NCT07053891 on ClinicalTrials.gov |
What this trial studies
This is an observational post‑marketing survey enrolling patients who are newly starting LUPKYNIS for lupus nephritis to capture safety and efficacy information in routine care. Data will be collected by Otsuka's Pharmacovigilance Department and may include patient questionnaires, adverse event reports, and medical record review during regular follow‑up. No experimental interventions are assigned and treating clinicians make all therapeutic decisions. The aim is to document real‑world tolerability and treatment outcomes outside of controlled clinical trials.
Who should consider this trial
Good fit: Ideal candidates are patients with lupus nephritis who are newly starting LUPKYNIS (voclosporin).
Not a fit: Patients who are not starting LUPKYNIS or who have conditions other than lupus nephritis are unlikely to receive direct benefit from this survey.
Why it matters
Potential benefit: If successful, the survey could improve understanding of LUPKYNIS safety and help clinicians and patients make better-informed treatment decisions for lupus nephritis.
How similar studies have performed: Randomized clinical trials have shown that voclosporin can improve renal response rates in lupus nephritis, but long‑term real‑world safety data remain more limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who are newly starting administration of LUPKYNIS for lupus nephritis Exclusion Criteria: \-
Where this trial is running
Osaka, Osaka
- Pharmacovigilance Department — Osaka, Osaka, Japan (Recruiting)
Study contacts
- Study coordinator: Pharmacovigilance Department Otsuka Pharmaceutical Co., Ltd
- Email: komaniwa.satoshi@otsuka.jp
- Phone: +81-6-6943-7722
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.