Iguratimod as Treatment for Refractory Lupus Nephritis

Study Overview
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Brief Summary
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This study is to evaluate the efficacy and safety of a novel chemical synthetic agent iguratimod as treatment of refractory lupus nephritis. All subjects should have at least one failed immunosuppressive treatment and suffer active nephritis at the screening stage. The study period is 52 week. All the subject will receive therapy of iguratimod combined with steroids.

Official Title
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Evaluation of Clinical Efficacy and Immunologic Response After Iguratimod Therapy in Refractory Lupus Nephritis

Conditions
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Lupus Nephritis

Intervention / Treatment
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* Drug: Iguratimod


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Active lupus nephritis: Fulfill ACR classification criteria (2009) for SLE Proteinuria ≥1g/24h at screening stage experience at least one failed therapy within one year before screening, including but not limit to cyclophosphamide, methotrexate, azathioprine, mycophenolate mofetil, cyclosporin, tacrolimus and leflunomide. The regime can be monotherapy or combination. Any regime should be at least applied for six months. 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iguratimod treating group<br>Iguratimod 25mg twice a day, oral administrated. | Drug: Iguratimod<br>* Iguratimod 25mg twice a day, oral administrated.<br>* Other names: T-614;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal remission rate |  | Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal remission rate |  | Week 24 | 
| Renal flare rate |  | Week 52 | 
| Number of participants with treatment-related adverse events | Adverse events are assessed by CTCAE v4.0 | Week 52 | 
| Systemic Lupus Erythematosus Disease Activity Index inSafety of Estrogens in Lupus Erythematosus National Assessment (SELENA-SLEDAI) |  | Week 52 | 
| British Isles Lupus Activity Group (BILAG) score |  | Week 52 | 
| PGA | Patient general assessment | Week 52 | 
| Quality of life | Measured by HAQ | Week 52 |