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

Aurinia Pharmaceuticals

Status: Enrolling

Conditions: Lupus Nephritis

Treatments: Drug: LUPKYNIS

Study type: Observational

Funder types: Industry

Identifiers

NCT05337124

AUR-VCS-2021-03

Details and patient eligibility

About

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).

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

300 participants in 1 patient group

Lupkynis Treatment Group

Treatment:

Drug: LUPKYNIS