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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iguratimod treating group | Experimental | Iguratimod 25mg twice a day, oral administrated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iguratimod | Drug | Iguratimod 25mg twice a day, oral administrated. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Renal remission rate | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Renal remission rate | Week 24 | |
| Renal flare rate | Week 52 | |
| Number of participants with treatment-related adverse events |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RenJi Hospital | Shanghai | Shanghai Municipality | 200001 | China |
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| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C519076 | iguratimod |
| C077313 | T 614 |
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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 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |