primary membranous nephropathy
Conditions
Interventions
Tacrolimus group:Tacrolimus 0.05-0.1mg/kg/d
Cyclophosphamide group:CTX 750mg/m2 ivgtt q2w for 8 weeks, then q4w for 4 weeks
Sponsors
Sichuan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) signing the written informed consent; 2) patients aged between 18~65 years old, male or female; 3) clinical diagnosis of primary nephrotic syndrome (albuminuria >3.5 g/d, serum albumin <30 g/L); 4) diagnosed as idiopathic membranous nephropathy by renal biopsy; 5) the results of pregnancy test for women of childbearing age were negative and agreed to adopt contraceptive measures; 6) serum creatinine <133umol/L.
Exclusion criteria
Exclusion criteria: 1) did not sign written informed consent or unable or unwilling to comply with the research plan approved by the researchers; 2) secondary membranous nephropathy (tumor, medicine, etc.); 3) have received hormone or other immunosuppressive drugs (cyclosporine and mycophenolate mofetil); 4) known to be allergic to tacrolimus, glucocorticoids, or any of the above drugs; 5) HBV serological index (HBsAg or / and HBeAg) positive, HCV positive or patients with abnormal liver function (2 times or more of ALT, AST or bilirubin above the upper limit of normal value, and continue to rise for 2 weeks); 6) the diagnosis was diabetes (defined as fasting blood glucose more than 7 mmol/L or diabetic symptoms + random blood sugar more than 11.1 mmol/L or 2 hours of glucose more than 11.1 mmol/L) or impaired glucose tolerance (2 hours of glucose 7.8 – 11 mmol/L); 7) there was a definite history of gastrointestinal ulcer and / or gastrointestinal bleeding within 6 months; 8) congenital or acquired immunodeficiency, or active tuberculosis and active CMV infection. Patients with severe infections need to use antibiotics intravenously; 9) patients with other serious physical or mental disorders; 10) congenital heart disease, arrhythmia, heart failure and other serious cardiovascular diseases; 11) women who are pregnant, nursing or unwilling to take contraceptive measures; 12) patients who took part in other clinical trials in the first three months; 13) the researchers judged that the patient's condition was not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate;Partial remission rate;Recurrence rate; | — |
Countries
China
Contacts
Public ContactLi Wang
Sichuan Provincial People's Hospital
Outcome results
None listed