A Prospective Observational Registry of Patients Treated With LUPKYNIS® (Voclosporin) in the US
Overview
- Phase
- N/A
- Intervention
- LUPKYNIS
- Conditions
- Lupus Nephritis
- Sponsor
- Aurinia Pharmaceuticals Inc.
- Enrollment
- 229
- Locations
- 1
- Primary Endpoint
- Effectiveness of LUPKYNIS
- Status
- Completed
- Last Updated
- 10 months ago
Overview
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.
Investigators
Eligibility 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)
Arms & Interventions
Lupkynis Treatment Group
Intervention: LUPKYNIS
Outcomes
Primary Outcomes
Effectiveness of LUPKYNIS
Time Frame: 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.
LUPKYNIS utilization patterns
Time Frame: 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.