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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05337124
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Aurinia Pharmaceuticals Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Aurinia Study Director
Principal Investigator Affiliation Aurinia Pharmaceuticals Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Lupus Nephritis
Additional Details

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.

Arms & Interventions

Arms

: Lupkynis Treatment Group

Interventions

Drug: - LUPKYNIS

LUPKYNIS treatment per the approved US Prescribing Information

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Site 00-05, S. Gate, California

Status

Recruiting

Address

Site 00-05

S. Gate, California, 90280