A Prospective Observational Registry of Patients Treated With LUPKYNIS® (Voclosporin) in the US
- Registration Number
- NCT05337124
- Lead Sponsor
- Aurinia Pharmaceuticals Inc.
- Brief Summary
This registry is an observational study designed to assess the utilization and effectiveness of LUPKYNIS in adult patients with lupus nephritis (LN) in the United States (US).
- Detailed Description
This registry is an observational study designed to assess the utilization and effectiveness of LUPKYNIS in patients with lupus nephritis (LN) in the United States (US). This registry is intended to benefit and support interests of patients, clinicians, regulatory bodies, payers, and industry by obtaining longitudinal data on LUPKYNIS.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- Lupus nephritis (LN) confirmed by biopsy
- Initiating or have initiated treatment with commercial LUPKYNIS as per US approved Prescribing Information (PI)
- Written informed consent
- Off-label use (Use of LUPKYNIS outside of the FDA-approved US Prescribing Information)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Lupkynis Treatment Group LUPKYNIS -
- Primary Outcome Measures
Name Time Method LUPKYNIS utilization patterns 12 months (1 year) to 60 months (5 years) The proportion of patients that had their first Urine Protein Creatinine Ratio (UPCR) \>0.5 mg within 6 months of initiating LUPKYNIS.
Effectiveness of LUPKYNIS 12 months (1 year) to 60 months (5 years) The proportion of patients that achieve Urine Protein Creatinine Ratio (UPCR) \<=0.5 mg after initiating LUPKYNIS by race, ethnicity, and previous LN treatment.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Site 00-05
🇺🇸S. Gate, California, United States