Lupus Nephritis
Conditions
Brief summary
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.
Interventions
DRUGIguratimod
Iguratimod 25mg twice a day, oral administrated.
Sponsors
RenJi Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Renal remission rate | Week 52 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal flare rate | Week 52 | — |
| Number of participants with treatment-related adverse events | Week 52 | Adverse events are assessed by CTCAE v4.0 |
| Systemic Lupus Erythematosus Disease Activity Index inSafety of Estrogens in Lupus Erythematosus National Assessment (SELENA-SLEDAI) | Week 52 | — |
| Renal remission rate | Week 24 | — |
| PGA | Week 52 | Patient general assessment |
| Quality of life | Week 52 | Measured by HAQ |
| British Isles Lupus Activity Group (BILAG) score | Week 52 | — |
Countries
China
Outcome results
None listed