A Study of Rituximab in Frontline Therapy for Glomerulonephritis
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| cohort A pathologically confirmed membranous nephropathy |
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| cohort B pathologically confirmed minimal change disease (MCD) or primary focal segmental glomerulosclerosis (FSGS) |
Outcome Measures
Primary Outcome Measures
- Remission Status [12 months]
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.
- Remission Status [8 weeks]
The number of subjects who achieve complete remission or partial remission in MCD/FSGS cohort at 8 weeks after treatment with Rituximab.
Secondary Outcome Measures
- Remission Status [6 months]
The number of subjects who achieve complete remission or partial remission in MN cohort at 6 months after treatment with Rituximab.
- Remission Status [16 weeks]
The number of subjects who achieve complete remission or partial remission in MCD/FSGS cohort at 16 weeks after treatment with Rituximab.
- Relapse [12 months]
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
- Incidence of adverse events (AEs) [12 months]
Will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Primary MN, MCD/FSGS patients confirmed by biopsy
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Consistent with nephrotic syndrome ( urinary protein>3.5g/d and serum albumin< 30g/L), and the researchers consider that immunosuppressive therapy is needed
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Estimated glomerular filtration rate ( eGFR≥60 ml/min/1.73m2 )
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Patients providing written informed consent before initiation of any study-related activities
Exclusion Criteria:
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Previous treatment of rituximab
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active bacteria, fungi, tuberculosis, viral infection
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Secondary MN, MCD, FSGS ( such as active hepatitis, systemic lupus erythematosus, drugs, malignant tumors, genetic or diabetic nephropathy, etc. )
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Severe cardiac insufficiency, cardiac function in NYHA grade III above
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Severe hypertension ( blood pressure>180/110 mmHg ) that cannot be controlled by drug treatment
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Pregnant or lactating female patients
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Uncontrolled concurrent diseases, including but not limited to：
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HIV infected ( HIV antibody positive )
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HBV or HCV infection
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Evidence of severe or uncontrolled systemic diseases ( such as severe mental, neurological, epilepsy or dementia )
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Those currently undergoing clinical trials of other drugs
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Other patients considered unsuitable for inclusion by the researchers
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Changhai Hospital | Shanghai | China | ||
| 2 | Renji Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | China | ||
| 3 | Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | China | ||
| 4 | Shanghai 6th People's Hospital | Shanghai | China | ||
| 5 | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | China |
Sponsors and Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
- Principal Investigator: GENGRU JIANG, doctor, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- XH-22-011