Registry of patients treated with LUPKYNIS for lupus nephritis in the US
A Prospective Observational Registry of Patients Treated With LUPKYNIS® (Voclosporin) in the US
This study is gathering information on how well LUPKYNIS works for adults with lupus nephritis in the US who are starting or have already started treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aurinia Pharmaceuticals Inc. Industry-sponsored |
| Locations | 1 site (S. Gate, California) |
| Trial ID | NCT05337124 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to gather data on the use and effectiveness of LUPKYNIS in adult patients diagnosed with lupus nephritis in the United States. By collecting longitudinal data, the study seeks to support the interests of patients, healthcare providers, regulatory agencies, and the pharmaceutical industry. Participants will be those who are initiating or have started treatment with LUPKYNIS, ensuring adherence to FDA-approved guidelines. The registry will not include patients using LUPKYNIS off-label.
Who should consider this trial
Good fit: Ideal candidates for this registry are adults with a confirmed diagnosis of lupus nephritis who are beginning treatment with LUPKYNIS.
Not a fit: Patients who are using LUPKYNIS off-label or do not have a confirmed diagnosis of lupus nephritis will not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the real-world effectiveness of LUPKYNIS, potentially improving treatment strategies for lupus nephritis.
How similar studies have performed: While this registry approach is common in observational studies, the specific focus on LUPKYNIS for lupus nephritis provides a novel perspective on its real-world application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Lupus nephritis (LN) confirmed by biopsy * Initiating or have initiated treatment with commercial LUPKYNIS as per US approved Prescribing Information (PI) * Written informed consent Exclusion Criteria: - Off-label use (Use of LUPKYNIS outside of the FDA-approved US Prescribing Information)
Where this trial is running
S. Gate, California
- Site 00-05 — S. Gate, California, United States (Recruiting)
Study contacts
- Study coordinator: Aurinia Study Director
- Email: clinicaltrials@auriniapharma.com
- Phone: 1-480-720-0394
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.