Membranous nephropathy
Conditions
Interventions
Group B:Cyclophosphamide combined with glucocorticoids
Group C:Low-dose Cyclophosphamide, glucocorticoid combined with rituximab
Group A:Rituximab
Sponsors
Shanghai Dongfang Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years (including 18 years old and 75 years old), regardless of gender and nationality; 2. Pathological diagnosis of primary membranous nephropathy; 3. eGFR>=30ml/min/1.73m^2; 4. PMN patients whose risk assessment of renal function progression meets at least 2 of the following criteria are defined as high-risk stage primary membranous nephropathy: (1) Serum creatinine >=133 µmol/L or eGFR decreased by 25% within 3-6 months; (2) 24-hour urine protein is greater than 8g or supportive treatment has been used, but nephrotic syndrome persists for more than 3-6 months; (3) Severe nephrotic syndrome such as serum albumin 250mg/d; (5) Anti-PLA2R antibody positive >=150RU/mL; 5. Patients with CD19+B lymphocyte count greater than 5/mm^3, neutrophil count >=1.5 x 10^9/L and platelet count >=75 x 10^9/L; 6. The patient signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Onset of nephrotic syndrome in infants; 2. Abnormal liver function, alanine aminotransferase or aspartate aminotransferase exceeding 2 times the upper limit of normal; 3. Clinically proven chronic active liver disease with cirrhosis or hepatitis B and C or HIV can detect viral replication; 4. History of active systemic infection or serious infection within the past 1 month; 5. During acute or chronic tuberculosis infection (positive tuberculin test, suspected tuberculosis foci on chest X-ray); 6. Severely impaired immune response (eg, hypoimmunoglobulinemia, severely decreased CD4 or CD8 cell counts); 7. Serious cardiovascular and cerebrovascular complications such as myocardial infarction, heart failure, and cerebral hemorrhage occurred within the past 3 months; 8. Laboratory tests that meet the following criteria need to be excluded: Hemoglobin 2.5 x upper limit of normal ; 9. Patients who have used immunosuppressive therapy in the past (including tripterygium preparations, etc.); 10. Pregnant or breastfeeding patients; 11. Patients with diabetes; 12. Accompanying or previous malignancy, remove fully treated skin basal or squamous cell carcinoma neck protocarcinoma; 13. A history of mental illness, which may interfere with participation in this research; 14. Those who are allergic to the active ingredients or any excipients in the prescription; 15. Other investigators judge that they are not suitable to be selected as investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| urine protein quantitative;renal function;serum albumin; | — |
Countries
China
Contacts
Public ContactLiu Na
Shanghai Dongfang Hospital
Outcome results
None listed