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

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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).

Conditions:

Lupus Nephritis

Study Start (Actual) 2022-03-25

Primary Completion (Estimated) 2026-11-15

Study Completion (Estimated) 2030-06-01

Enrollment (Estimated) 300

Study Type OBSERVATIONAL

Phase N/A

Locations:

📍 S. Gate, California, United States

Eligibility Criteria

Description

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)

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted2022-03-22
First Submitted that Met QC Criteria2022-04-13
First Posted2022-04-20

Study Record Updates

Last Update Submitted that Met QC Criteria2024-05-22
Last Update Posted2024-05-23
Last Verified2024-05