LUPKYNIS US Registry Trial

Overview

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.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Vikas Majithia, M.B.B.S., M.P.H.

Closed for enrollment

Contact information:

Vikas Majithia M.B.B.S., M.P.H.

(904) 953-2101

Majithia.Vikas@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20545771

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