Lupus Nephritis
Conditions
Keywords
lupus, nephritis, iguratimod
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.
Interventions
DRUGIguratimod
25mg twice a day, orally administrated
DRUGCyclophosphamide
1g/m², every 4 weeks, intravenous
DRUGAzathioprine
2mg/kg·d, once a day, orally administrated
DRUGSteroids
Prednisone, methylprednisolone or prednisonlone, once a day, orally administrated. Steroids should be 1mg/kg·d in the beginning four weeks, then tapered 5-10mg/d every two weeks till 30mg/d, then tapered 2.5-5mg/d every two weeks. After 24 weeks of follow-up, a patient should receive steroids no more than 10mg/d. Patients may receive temporal high dose of steroids (1mg/kg·d) because of symptoms outside of kidney, for no more than two weeks. All the dosage of steroids above is calculated by prednisone.
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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 * 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
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 |
| Renal remission rate | Week 24 | — |
| BILAG score | Week 52 | British Isles lupus assessment group score |
| PGA | Week | Patient general assessment |
| SLEDAI-2K score | Week 52 | SLE SLE disease activity index (2000) |
Countries
China
Contacts
Primary ContactChunde Bao, MD
Backup ContactQingran Yan, MD
Outcome results
None listed