A Prospective Observational Registry of Patients Treated With LUPKYNIS® (Voclosporin) in the US

Aurinia Pharmaceuticals Inc.229 enrolled

Overview

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).

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.

Study Type

OBSERVATIONAL

Enrollment

229

Conditions

Lupus Nephritis

Interventions

LUPKYNISDRUG

LUPKYNIS treatment per the approved US Prescribing Information

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Site 00-05

South Gate, California, United States

Outcomes

Primary Outcomes

LUPKYNIS utilization patterns

The proportion of patients that had their first Urine Protein Creatinine Ratio (UPCR) \>0.5 mg within 6 months of initiating LUPKYNIS.

Time frame: 12 months (1 year) to 60 months (5 years)

Effectiveness of LUPKYNIS

The proportion of patients that achieve Urine Protein Creatinine Ratio (UPCR) \<=0.5 mg after initiating LUPKYNIS by race, ethnicity, and previous LN treatment.

Time frame: 12 months (1 year) to 60 months (5 years)

Data from ClinicalTrials.gov

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