This study included patients with glomerulonephritis who planned to receive rituximab treatment, and observed the efficacy and safety of rituximab in different glomerulonephritis in the real world. According to the pathological types of glomerulonephritis, they were divided into two cohorts : membranous nephropathy ( MN ) group or minimal change disease / focal segmental glomerulosclerosis ( MCD / FSGS ) group.
A total of 100 patients with glomerulonephritis who planned to receive rituximab treatment were enrolled in the study. According to the pathological types of glomerulonephritis, they were divided into MN cohort and MCD / FSGS cohort, with 50 patients in each cohort. All eligible patients who meet the inclusion and exclusion criteria will be invited to participate in this study.
Study Type
OBSERVATIONAL
Enrollment
100
Changhai Hospital
Shanghai, China
NOT_YET_RECRUITINGRenji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
NOT_YET_RECRUITINGRuijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
NOT_YET_RECRUITINGRemission Status
The number of subjects who achieve complete remission or partial remission in MN cohort at 12 months after treatment with Rituximab. CR was defined as urinary protein quantitative\<0.3g and Albutein\>35g/L in 24 hours. PR was defined as urinary protein quantitative\>0.3g,but\<3.5g or urinary protein decreased by 50% compared with the baseline level and the renal function was stable ( serum creatinine increased by\<20% compared with the baseline level ) in 24 hours.
Time frame: 12 months
Remission Status
The number of subjects who achieve complete remission or partial remission in MCD/FSGS cohort at 8 weeks after treatment with Rituximab.
Time frame: 8 weeks
Remission Status
The number of subjects who achieve complete remission or partial remission in MN cohort at 6 months after treatment with Rituximab.
Time frame: 6 months
Remission Status
The number of subjects who achieve complete remission or partial remission in MCD/FSGS cohort at 16 weeks after treatment with Rituximab.
Time frame: 16 weeks
Relapse
The number of subjects who relapse within 12 months in MCD/FSGS cohort. A relapse is defined as reappearance of Urine Protein Creatinine Ratio (based on 24-hour urine collection) \> 3.5 after complete or partial remission
Time frame: 12 months
Incidence of adverse events (AEs)
Will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
Time frame: 12 months
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Shanghai 6th People's Hospital
Shanghai, China
NOT_YET_RECRUITINGXinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
RECRUITING