Lupus Nephritis
Conditions
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.
Interventions
DRUGLUPKYNIS
LUPKYNIS treatment per the approved US Prescribing Information
Sponsors
United BioSource, LLC
Aurinia Pharmaceuticals Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed