The Iguratimod Effect on Lupus Nephritis (IGeLU)

• Status: Unknown status
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RenJi Hospital
• Treatments: Azathioprine; Cyclophosphamide

Criteria

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