nephrotic syndrome
Conditions
Interventions
Experimental group:Rituximab administration with a one-week interval
Control group:Rituximab administration with a six-month interval
Sponsors
Liuzhou Hospital of Guangzhou Women and Children’s Medical Center
Eligibility
Sex/Gender
All
Age
2 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Aged 2 to 18 years; 2. patients diagnosed with frequent relapsing or steroid-dependent primary nephrotic syndrome, in accordance with the 2016 Evidence-Based Guidelines of Pediatric Steroid-Sensitive, Relapsing/Dependent Nephrotic Syndrome ; 3. Without prior use of other immunosuppressants such as CTX, MMF, TAC, or biological agents like RTX; 4.patients in complete remission (urinary protein negative for more than one week); 5.The steroid dose maintaining complete remission is controlled at = 90 ml/min/1.73 m²; 7.The children and their family voluntarily participate and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Secondary nephrotic syndrome, such as lupus nephritis, IgA nephropathy, Henoch-Schönlein purpura nephritis, hepatitis B, hepatitis C-related nephropathy; 2. A history of steroid-resistance; 3.White blood cell count < 3 × 10?/L, hemoglobin < 90 g/L, or platelet count < 100 × 10?/L; 4. Combined with chronic infections, such as tuberculosis, hepatitis B, hepatitis C, or HIV infection; 5. Combined with acute infectious conditions, such as upper respiratory tract infections; 6. Receive a live vaccine within 4 weeks prior to randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| sustained complete remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| sustained complete remission time;sustained complete remission;Total peripheral blood B cell count;Memory B cell count;Blood concentration of RTX; | — |
Countries
China
Contacts
Public ContactCai xiaoyi
Liuzhou Hospital of Guangzhou Women and Children’s Medical Center
Outcome results
None listed