nephrotic syndrome
Conditions
Interventions
low dose:Rituximab
Sponsors
Jiangsu Province People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18-75 years(including 18 and 75 years), regardless of gender and nationality; 2.It is consistent with refractory nephrotic syndrome. The pathological type is minimal change nephropathy (MCD), focal stage glomerulosclerosis (FSGS) or IgA nephropathy; According to the pathological type, the first-line treatment (hormone and (or) immunosuppressant) has not achieved complete remission for at least 3 months; Related definitions: a) hormone therapy resistance: it is defined as nephrotic syndrome that has not achieved complete remission (CR) or partial remission (PR) after 8 weeks of treatment with sufficient prednisone (1mg/kg per day, maximum dose 60mg/ day; or 2mg/kg every other day, maximum dose 120mg/ other day) (sufficient hormone shall not be less than 6 weeks); b) Hormone dependence: relapse occurred for 2 consecutive times during hormone therapy or within 2 weeks after stopping hormone therapy; c) Recurrent recurrence: 3 recurrences within any 12 months, or 2 recurrences within 6 months; 3.Refractory membranous nephropathy (MN) or newly diagnosed membranous nephropathy which the risk assessment is at medium and high risk for renal dysfunction. 4.Laboratory examination meets the following conditions: 24h urinary protein >= 3.5g, and serum albumin = 30 ml/min / 1.73 m2; Cd19+b lymphocyte count is greater than 5 / mm3, neutrophil count >=1.5 x 10^9 /l and platelet count >= 75 x 10^9 /l patients; 5.The patient signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. eGFR <30 ml/min/1.73 m2; 2. The onset of nephrotic syndrome in infants and children; 3. Abnormal liver function, alanine aminotransferase or aspartate aminotransferase 2 times higher than the upper limit of normal value; 4. Potential hepatitis B or HIV positive, systemic lupus erythematosus, amyloidosis, allergic purpura; 5. Secondary nephrotic syndrome; 6. More than one infection (sepsis, sinusitis, bronchitis, pneumonia, febrile infection, herpes zoster, respiratory tract infection, fungal infection, infection of unknown etiology) occurred in the past month; 7. Current or previous anti tuberculosis treatment; 8. Severe impairment of immune response (such as hypoimmunoglobulinemia, severe decrease of CD4 or CD8 cell count); 9. Severe cardiovascular and cerebrovascular complications such as myocardial infarction, heart failure and cerebral hemorrhage occurred in the past six months; 10. Patients with neutrophil count less than 1.5 x 10^9 / L and / or platelet count less than 75 x 10^9 / l had CD19 + B lymphocyte count less than 5 / mm3; 11. Immunosuppressants (cytotoxic drugs, Tripterygium wilfordii preparations, etc.) can not be stopped temporarily; 12. Pregnancy or lactation; 13. Allergic to active ingredients or any excipients in the prescription.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of complications; | — |
Countries
China
Contacts
Public ContactXing Changying
Jiangsu Province People's Hospital
Outcome results
None listed