Survey of LUPKYNIS (voclosporin) use in lupus nephritis
Official title: LUPKYNIS Drug-use Results Survey
Run by Otsuka Pharmaceutical Co., Ltd. · NCT07053891 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 15 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Otsuka Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Osaka) |
| Status | Recruiting |
| Started | September 17, 2025 |
| Main results expected | June 30, 2031 |
| Study ends | June 30, 2032 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT07053891 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with lupus nephritis who are newly starting LUPKYNIS (voclosporin).
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who are newly starting administration of LUPKYNIS for lupus nephritis Exclusion Criteria: \-
Where it's running
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Pharmacovigilance Department
Osaka, Japan Recruiting
Study contacts
- Study coordinator: Pharmacovigilance Department Otsuka Pharmaceutical Co., Ltd
- Email: komaniwa.satoshi@otsuka.jp
- Phone: +81-6-6943-7722
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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LUPKYNIS in combination with belimumab, obinutuzumab, or anifrolumab for lupus nephritis
This trial tests whether adding LUPKYNIS to other biologics (belimumab, obinutuzumab, or anifrolumab) plus a mycophenolic acid analog and a steroid can rapidly improve kidney health in adults with biopsy-proven lupus nephritis.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.