The Iguratimod Effect on Lupus Nephritis (IGeLU)
The Iguratimod Effect on Lupus Nephritis (IGeLU)
This study is a 52-week, randomized, open, active-controlled trial of patients with active
 diffused lupus nephritis, to assess the efficacy and safety of a novel chemical synthetic
 agent iguratimod. The subjects will randomly receive iguratimod or cyclophosphamide followed
 with azathioprine, both combined with steroids.
Inclusion Criteria:

 -  Active lupus nephritis:

 -  Fulfill ACR classification criteria (2009) for SLE

 -  Proteinuria ≥1g/24h at screening

 -  Nephritis of class III, IV, V, III+IV or IV+V, confirmed by renal pathology
 within 90 days prior to screening

 -  Body weight ≥40kg

 -  SLE-2K score ≥8

 -  Agreement of contraception

 -  Informed consent obtained

 Exclusion Criteria:

 -  Active severe SLE-driven renal disease or unstable renal disease at screening

 -  Active severe or unstable neuropsychiatric SLE

 -  Clinically significant active infection including ongoing and chronic infections

 -  History of receiving cyclophosphamide, azathioprine, tacrolimus , mycophenolate moetil
 or rituximab treatment with 90 days prior to screening

 -  History of human immunodeficiency virus (HIV)

 -  Confirmed Positive tests for hepatitis B or positive test for hepatitis C

 -  Active tuberculosis

 -  Live or attenuated vaccine within 4 weeks prior to screening

 -  Subjects with significant hematologic abnormalities

 -  Abnormal liver function test at screening (ALT, AST or total bilirubin over 2 fold of
 upper normal level

 -  History of peptic ulcer or GI bleeding; treatment with warfarin or other
 anticoagulants within last 14 days