LUPKYNIS US Registry Trial
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 22-005028
NCT ID: NCT05337124
Sponsor Protocol Number: AUR-VCS-2021-03
About this study
This observational study is a registry designed to assess the utilization and effectiveness of LUPKYNIS in adult patients with lupus nephritis (LN) in the United States (US).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Male or female age 18 or older.
- LN confirmed by biopsy within 24 months prior to enrollment. Biopsy results older than 24 months may be considered after review and approval by a medical monitor to confirm eligibility prior to enrollment.
- Initiating or have initiated treatment with commercial LUPKYNIS as per the US approved Prescribing Information (PI) within the 12 months prior to consent. In cases where LUPKYNIS treatment was initiated greater than 12 months prior to consent and/or there was an interruption in treatment, a medical monitor will review on a case-by-case basis to determine eligibility.
- The following baseline data obtained prior to LUPKYNIS treatment initiation must be available:
- blood pressure;
- renal laboratory assessments including:
- urinary protein quantification as shown by UPCR, UACR, 24-hour urine test, urinalysis or urine dipstick test;
- serum creatinine and/or eGFR;
- Have access to US healthcare insurance;
- Ability to understand and provide written informed consent.
Exclusion Criteria:
- Off-label use (Use of LUPKYNIS outside of the FDA-approved US Prescribing Information).
Eligibility last updated 8/8/23. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available