A Study of Rituximab in Frontline Therapy for Glomerulonephritis
NCT ID: NCT05761938
Last Updated: 2023-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2023-02-01
2025-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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cohort A
pathologically confirmed membranous nephropathy
No interventions assigned to this group
cohort B
pathologically confirmed minimal change disease (MCD) or primary focal segmental glomerulosclerosis (FSGS)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Consistent with nephrotic syndrome ( urinary protein\>3.5g/d and serum albumin\< 30g/L), and the researchers consider that immunosuppressive therapy is needed
* Estimated glomerular filtration rate ( eGFR≥60 ml/min/1.73m2 )
* Patients providing written informed consent before initiation of any study-related activities
Exclusion Criteria
* 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：
1. HIV infected ( HIV antibody positive )
2. HBV or HCV infection
3. Evidence of severe or uncontrolled systemic diseases ( such as severe mental, neurological, epilepsy or dementia )
* Those currently undergoing clinical trials of other drugs
* Other patients considered unsuitable for inclusion by the researchers
18 Years
80 Years
ALL
No
Sponsors
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Gengru Jiang
Director of Renal Division, Department of Internal Medicine
Principal Investigators
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GENGRU JIANG, doctor
Role: PRINCIPAL_INVESTIGATOR
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Locations
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Changhai Hospital
Shanghai, , China
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Shanghai 6th People's Hospital
Shanghai, , China
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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zhiyong guo, doctoral
Role: primary
leyi gu, doctoral
Role: primary
wen zhang, doctoral
Role: primary
niansong wang, doctoral
Role: primary
Other Identifiers
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XH-22-011
Identifier Type: -
Identifier Source: org_study_id
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