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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cohort A | pathologically confirmed membranous nephropathy | ||
| cohort B | pathologically confirmed minimal change disease (MCD) or primary focal segmental glomerulosclerosis (FSGS) |
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| Measure | Description | Time Frame |
|---|---|---|
| Remission 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. | 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Remission Status | The number of subjects who achieve complete remission or partial remission in MN cohort at 6 months after treatment with Rituximab. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Previous treatment of rituximab
active bacteria, fungi, tuberculosis, viral infection
Secondary MN, MCD, FSGS ( such as active hepatitis, systemic lupus erythematosus, drugs, malignant tumors, genetic or diabetic nephropathy, etc. )
Severe cardiac insufficiency, cardiac function in NYHA grade III above
Severe hypertension ( blood pressure>180/110 mmHg ) that cannot be controlled by drug treatment
Pregnant or lactating female patients
Uncontrolled concurrent diseases, including but not limited to:
Those currently undergoing clinical trials of other drugs
Other patients considered unsuitable for inclusion by the researchers
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Primary MN, MCD/FSGS patients confirmed by biopsy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| GENGRU JIANG, doctor | Contact | +86-13816238339 | jianggengru@xinhuamed.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| GENGRU JIANG, doctor | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Not yet recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| ID | Term |
|---|---|
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| 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 | 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. | 12 months |
| Renji Hospital, Shanghai Jiao Tong University School of Medicine | Not yet recruiting | Shanghai | China |
|
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Not yet recruiting | Shanghai | China |
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| Shanghai 6th People's Hospital | Not yet recruiting | Shanghai | China |
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| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | China |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |