The Iguratimod Effect on Lupus Nephritis (IGeLU)
Phase 2
- Conditions
- Lupus Nephritis
- Interventions
- Registration Number
- NCT02936375
- Lead Sponsor
- RenJi Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cyc+AZA Azathioprine Patients will receive cyclophosphamide in the first half of study (usually to 24 weeks), followed with azathioprine till the end of follow-up. Patients will also receive steroids as combinational therapy, as well as auxiliary treatment (such as vitamin D, gastrointestinal agents, blood pressure medications, if any) Iguratimod Steroids Patients will receive iguratimod over the whole follow-up, combined with steroids, as well as auxiliary treatment (such as vitamin D, gastrointestinal agents, blood pressure medications, if any) Cyc+AZA Steroids Patients will receive cyclophosphamide in the first half of study (usually to 24 weeks), followed with azathioprine till the end of follow-up. Patients will also receive steroids as combinational therapy, as well as auxiliary treatment (such as vitamin D, gastrointestinal agents, blood pressure medications, if any) Iguratimod Iguratimod Patients will receive iguratimod over the whole follow-up, combined with steroids, as well as auxiliary treatment (such as vitamin D, gastrointestinal agents, blood pressure medications, if any) Cyc+AZA Cyclophosphamide Patients will receive cyclophosphamide in the first half of study (usually to 24 weeks), followed with azathioprine till the end of follow-up. Patients will also receive steroids as combinational therapy, as well as auxiliary treatment (such as vitamin D, gastrointestinal agents, blood pressure medications, if any)
- Primary Outcome Measures
Name Time Method renal remission rate Week 52
- Secondary Outcome Measures
Name Time Method Renal remission rate Week 24 BILAG score Week 52 British Isles lupus assessment group score
PGA Week Patient general assessment
Renal flare rate Week 52 Number of participants with treatment-related adverse events Week 52 adverse events are assessed by CTCAE v4.0
SLEDAI-2K score Week 52 SLE SLE disease activity index (2000)
Trial Locations
- Locations (2)
RenJi Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai Tongji Hospital, Tongji University School of Medicine
🇨🇳Shanghai, Shanghai, China