Aurinia Renal Response in Active Lupus With Voclosporin
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Intervention: Voclosporin; Placebo Oral Capsule
Intervention description: calcineurin inhibitor; matching placebo capsule
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 358.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: lupus nephritis; calcineurin inhibitors; voclosporin

Summary:

      The purpose of this study is to assess the efficacy of voclosporin compared with placebo in
      achieving renal response after 52 weeks of therapy in subjects with active lupus nephritis.
    

Eligibility criteria:

        Key Inclusion Criteria:

        - Subjects with evidence of active nephritis, defined as follows:

          -  Kidney biopsy result within 2 years prior to screening indicating Class III, IV-S,
             IV-G (alone or in combination with Class V), or Class V LN with a doubling or greater
             increase of UPCR within the last 6 months to a minimum of ≥1.5 mg/mg for Class III/IV
             or to a minimum of ≥2 mg/mg for Class V at screening. Biopsy results over 6 months
             prior to screening must be reviewed with a medical monitor to confirm eligibility.

        OR

          -  Kidney biopsy result within 6 months prior to screening indicating Class III, IV-S or
             IV-G (alone or in combination with Class V) LN with a UPCR of ≥1.5 mg/mg at screening.

        OR

          -  Kidney biopsy result within 6 months prior to screening indicating Class V LN and a
             UPCR of ≥2 mg/mg at screening.

               -  Women of childbearing potential must have a negative serum pregnancy test at
                  screening and a negative urine pregnancy test at baseline.

        Exclusion Criteria:

          -  Estimated glomerular filtration rate (eGFR) of ≤45 mL/minute at screening.

          -  Current or medical history of:

               -  Congenital or acquired immunodeficiency.

               -  In the opinion of the Investigator, clinically significant drug or alcohol abuse
                  within 2 years prior to screening.

               -  Malignancy within 5 years of screening, with the exception of basal and squamous
                  cell carcinomas treated by complete excision.

               -  Lymphoproliferative disease or previous total lymphoid irradiation.

               -  Severe viral infection or known HIV infection.

               -  Active tuberculosis (TB), or known history of TB/evidence of old TB if not taking
                  prophylaxis with isoniazid.

          -  Other known clinically significant active medical conditions, such as:

               -  Severe cardiovascular disease, liver dysfunction or chronic obstructive pulmonary
                  disease or asthma requiring oral steroids or any other overlapping autoimmune
                  condition for which the condition or the treatment of the condition may affect
                  the study assessments or outcomes.