A Study of Rituximab in Frontline Therapy for Glomerulonephritis

Shanghai Jiao Tong University

Status

Enrolling

Conditions

Glomerulonephritis

Study type

Observational

Funder types

Other

Identifiers

NCT05761938

XH-22-011

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Primary MN, MCD/FSGS patients confirmed by biopsy
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

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：
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