To demonstrate that the treatment effect in lupus nephritis of MZR is non-inferior to that of standard therapy CTX through analyzing overall remission rate after treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
Total Remission rate
Time frame: 52 weeks
Complete Remission rate
Time frame: 52 weeks
Partial Remission rate
Time frame: 52 weeks
Changes of Overall Remission rate
Time frame: 8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks
Changes of Complete Remission rate
Time frame: 8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks
Changes of partial remission rate
Time frame: 8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks
Treatment failure rate
Time frame: 52 weeks
Changes and percentage change of 24 hours urine protein and serum albumin from the baseline
Time frame: 8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks
Changes of and percentage change of SCr, eGFR and BUN from the baseline
Time frame: 8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks
Changes of immunological test (C3, Anti-DNA antibody, ANA, Anti-Sm antibody and Anti-phospholipid antibody) from baseline
Time frame: 20 weeks and 52 weeks
Changes of SLE-DAI score from baseline
Time frame: 20 weeks and 52 weeks
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Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
The Third Affiliated Hospital of the Third Military Medical University (Daping Hospital)
Chongqing, Chongqing Municipality, China
The first Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
...and 16 more locations
Progression to End-Stage Renal Disease or Doubling of SCr through the study.
Time frame: 52 weeks