Aurinia Early Urinary Protein Reduction Predicts Response
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Intervention: voclosporin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: lupus nephritis; calcineurin inhibitors; voclosporin

Summary:

      An exploratory study assessing the ability of biomarkers measured at 8 weeks to predict
      clinical response over 24 and 48 weeks in subjects taking voclosporin 23.7 mg twice daily
      (BID) in combination with standard of care in patients with active lupus nephritis
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Diagnosis of systemic lupus erythematosus (SLE) according to the American College of
             Rheumatology criteria (1997; see Appendix 6).

          -  Kidney biopsy within 24 months prior to screening with a histologic diagnosis of lupus
             nephritis International Society of Nephrology/Renal Pathology Society Classes III,
             IV-S or IV-G, (A) or (A/C); or Class V, alone or in combination with Class III or IV.

          -  Laboratory evidence of active nephritis at screening, defined as: Class III, IV-S or
             Class IV-G (proteinuria ≥1000 mg/24 hours when assessed by 24 hour urine collection,
             defined by a urine protein/creatinine ratio (UPCR) of ≥1.0 mg/mg assessed in a first
             morning void urine specimen). Class V, alone or in combination with Class III or IV,
             (proteinuria ≥1,500 mg/24 hours when assessed by 24 hour urine collection, defined by
             a UPCR of ≥1.5 mg/mg assessed in a first morning void urine specimen).

        Key Exclusion Criteria:

          -  Estimated glomerular filtration rate (eGFR) as calculated by the Chronic Kidney
             Disease Epidemiology Collaboration equation of ≤45 mL/min/1.73 m2 at screening

          -  Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected
             to require dialysis during the study period.

          -  A previous kidney transplant or planned transplant within study treatment period.

          -  Malignancy within 5 years of screening, with the exception of basal and squamous cell
             carcinomas treated by complete excision. Subjects with cervical dysplasia that is
             cervical intraepithelial neoplasia 1, but have been treated with conization or loop
             electrosurgical excision procedure, and have had a normal repeat Papanicolaou smear
             test (PAP) are allowed.

          -  Lymphoproliferative disease or previous total lymphoid irradiation.

          -  Severe viral infection (such as Cytomegalovirus (CMV), Hepatitis B virus (HBV),
             Hepatitis C virus (HCV)) within 3 months of screening; or known human immunodeficiency
             virus 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 including congestive heart failure, history of cardiac
             dysrhythmia or congenital long QT syndrome. QT interval duration corrected for heart
             rate using method of Fridericia (QTcF) exceeding 480 msec in the presence of a normal
             QRS interval (<110 msec) at time of screening will result in exclusion.

          -  Liver dysfunction (aspartate aminotransferase, alanine aminotransferase, or bilirubin
             greater than 2.5 times the upper limit of normal) at screening and confirmed before
             enrollment.

          -  Chronic obstructive pulmonary disease or asthma requiring oral steroids.

          -  Bone marrow insufficiency unrelated to active systemic lupus erythematosus (SLE)
             (according to Investigator judgment) with white blood cell count <2,500/mm3; absolute
             neutrophil count <1.3 × 103/μL; thrombocytopenia (platelet count <50,000/mm3).

          -  Active bleeding disorders.

          -  Current infection requiring IV antibiotics.