membranous nephropathy
Conditions
Interventions
Control group:The control group was given tacrolimus monotherapy plus the basic treatment plan. Tacrolimus capsules were started at 0.05 mg/kg/d, taken orally twice a day, with a maximum dose of 6 mg/
for those who responded to the treatment, it was continued for 12 months, then gradually reduced over the next 6 months, and discontinued at 18 months.
trial group:The experimental group was given Ma Fu Yishen granule + basic treatment plan. Experimental group took Chinese medicine compound granules orally, once in the morning and once in the evening
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) Age 18-80 male or female; (2) Meet the diagnostic criteria for primary membranous nephropathy in Western medicine; (3) Kidney function meets the criteria for chronic kidney disease stage 2 or higher i.e. estimated glomerular filtration rate (eGFR) according to the CKD-EPI formula is =60 mL/min/1.73m2; (4) According to the 2021 KDIGO guidelines the risk stratification assessment for membranous nephropathy is classified as moderate risk with best supportive treatment for 3 months or more before enrollment and 24-hour urine protein excretion of =3.5g and urine protein reduction of =50%; or if the patient has already received full-course best supportive treatment in the past and 24-hour urine protein excretion still meets the above criteria the patient may be enrolled upon confirmation by the investigator; (5) The patient voluntarily participates in this study and signs an informed consent form.
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 |
|---|---|
| Clinical remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| estimated glomerular filtration rate;creatinine;Total cholesterol;TCM Symptom Score;albumin;Cytokine;Clinical remission rate;triglyceride;Anti-PLA2R; | — |
Countries
China
Contacts
Public ContactBaoli Liu
Beijing traditional Chinese medicine hospital affiliated to Capital Medical University
Outcome results
None listed