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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
25mg twice a day, orally administrated
1g/m², every 4 weeks, intravenous
2mg/kg·d, once a day, orally administrated
RenJi Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGShanghai Tongji Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGrenal remission rate
Time frame: Week 52
Renal remission rate
Time frame: Week 24
Renal flare rate
Time frame: Week 52
Number of participants with treatment-related adverse events
adverse events are assessed by CTCAE v4.0
Time frame: Week 52
SLEDAI-2K score
SLE SLE disease activity index (2000)
Time frame: Week 52
BILAG score
British Isles lupus assessment group score
Time frame: Week 52
PGA
Patient general assessment
Time frame: Week
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.