LUPKYNIS US Registry Trial

Overview

Información sobre este estudio

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).

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Jacksonville, Fla.

Investigador principal de Mayo Clinic

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

Cerrado para la inscripción

Contact information:

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

(904) 953-2101

Majithia.Vikas@mayo.edu

More information

Publicaciones

Publications are currently not available
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CLS-20545771

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