membranous nephropathy
Conditions
Interventions
trial group:Patients in the trial group were given Mafuyishen Granules orally one bag/time twice a day once in the morning and once in the evening after meals.
Control group:Tacrolimus capsules 0.05-0.1mg/kg/d were taken orally twice (12 hours apart). Tacrolimus capsules were given from a small dose (0.05mg/kg/d) (the maximum dose was 6mg/d), and then the do
Sponsors
Beijing traditional Chinese medicine hospital affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) 18-80 years old male or female; (2) Primary (idiopathic) membranous nephropathy was diagnosed by renal biopsy; (3) The renal function is in accordance with chronic kidney disease stage 3a and above that is the glomerular filtration rate (EGFR) estimated by CKD-EPI formula is = 45 ml/min/1.73 m2; (4) According to the guideline of 2021 KDIGO those whose risk of membranous nephropathy is classified as medium risk still meet the diagnostic criteria of nephrotic syndrome after the best supportive treatment for 3 months or more before entering the group or their urine protein is still > 4g after 24 hours of laboratory tests and the decrease of urine protein is = 50%; Or those who have gone through the best supportive treatment in the past and the 24-hour urine protein still meets the above standards can be enrolled after being confirmed by the researchers; According to the guideline of 2021 KDIGO those who are classified as high risk of membranous nephropathy can be directly enrolled in the group; (5) Patients voluntarily participate in this study and sign informed consent.
Exclusion criteria
Exclusion criteria: (1) Progressive membranous nephropathy (defined as: progressive decline of renal function and eGFR decreased by more than 30% during two follow-up periods (3 months); Or renal biopsy showed necrotizing capillary inflammation and > 50% new moon formation). (2) Patients with other kidney diseases such as IgA nephropathy hypertensive benign arteriolar nephrosclerosis diabetic nephropathy etc. (3) Have received any of the following therapeutic drugs for membranous nephropathy: 1) Have received immunosuppressants such as prednisone (or equivalent drugs) mycophenolate mofetil tacrolimus cyclosporine azathioprine tripterygium wilfordii and hydroxychloroquine (including but not limited to immunosuppressants such as chemical drugs Chinese patent medicines or Chinese herbal medicines except alkylating agents and immunosuppressants against CD20 and B-cell clearance drugs) within 3 months before screening; 2) Patients were treated with alkylating agents (such as cyclophosphamide and chlorambucil) within 6 months before screening; 3) Have received any anti-CD20 therapy or any drugs with B cell clearance within 9 months before screening; (4) Other indexes of rheumatic immune diseases are abnormal; (5) Persistent bacterial or viral infection such as active hepatitis B; (6) Abnormal liver function with alanine aminotransferase (ALT) exceeding the upper limit of normal by more than 5 times (only at the time of enrollment screening); (7) Patients with a history of malignant tumor HIV infection mental illness acute central nervous system diseases and severe gastrointestinal diseases; (8) Combined with life-threatening complications such as severe infection; (9) Patients with cardiovascular diseases (such as coronary heart disease) arrhythmia cerebrovascular diseases (such as cerebral hemorrhage and cerebral infarction) or serious organ diseases and dysfunction (including but not limited to cor pulmonale cardiac insufficiency hepatic insufficiency etc.) or diabetes; (10) those who are known to be allergic to the components of the Chinese medicine used; (11) Pregnant and lactating women for women of childbearing age who have not undergone sterilization: do not agree to use appropriate methods of contraception such as oral contraceptives intrauterine devices or barrier contraception combined with spermicide during the treatment period and at least 12 months after the last administration of the research drug; (12) researcher who are undergoing other clinical trial; (13) Other circumstances that the researcher thinks are not suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24 hours urinary total protein; | — |
Secondary
| Measure | Time frame |
|---|---|
| albumin;Anti-PLA2R;creatinine;TCM Symptom Score;estimated glomerular filtration rate;Low-density lipoprotein;Total cholesterol;triglyceride; | — |
Countries
China
Contacts
Public ContactBaoli Liu
Beijing traditional Chinese medicine hospital affiliated to Capital Medical University
Outcome results
None listed