Membranous Nephropathy
Conditions
Interventions
MFSD Group:MAFU Granules + basic treatment
CsA Group:cyclosporine + basic treatment
Sponsors
Beijing Hospital of TCM, Capital Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 to 75 years old; 2. It meets the diagnostic criteria for idiopathic membranous nephropathy in western medicine (4th edition of Nephrology), and the specific contents are shown in the above diagnostic criteria; 3. Patients who have signed informed consent; 4. With normal renal function, the estimated glomerular filtration rate (eGFR) is taken as the evaluation standard of renal function, i.e., eGFR > 90 mL/min 1.73 m2 (CKD-Epi formula); 5. The following conditions were met: (1) The 24-hour urinary protein quantity was greater than 3.5g after two consecutive reviews; (2) The serum albumin was less than 30 g/L, and (3) the serum PLA2R antibody titer was greater than 50 RU/ml. The enrolled subjects needed to meet the conditions (1) (2), or (1) (3), or (1) (2) (3); (Note: Condition 5 limited the participants in this study to be the risk and part of the high-risk population for membranous nephropathy as defined by the KDIGO guidelines. The specific criteria of KDIGO are shown in the table below). 6. Patients with membranous nephropathy whose syndrome differentiation in traditional Chinese medicine was Yin rather than Yang. 7. Those who have not taken or have stopped taking hormones and immunosuppressants for three months (Note: hormones refer to various oral or intravenous steroid glucocorticoids; Immunosuppressive agents refer to various immunosuppressive drugs that have been clinically used for the treatment of membranous nephropathy, including but not limited to: benzobutanoate, cyclophosphamide, calcineurin inhibitor tacrolimus and cyclosporine A, rapamycin target protein inhibitor sirolimus, cell proliferation inhibitor mycophenolate mofetil, azathioprine, immunosuppressive Chinese patent medicine tripterygium glycosides, kunxian capsule, and biological agents, such as CD20 monoclonal antibody (rituximab), B cell activation factor (BAFF) monoclonal antibody, etc.
Exclusion criteria
Exclusion criteria: 1. Progressive membranous nephropathy (defined as progressive decline in renal function with a decrease of eGFR of more than 30% during two follow-up periods (3 months); Or renal biopsy show necrotizing capillary inflammation and > 50% neomoon formation). 2. Patients with other kidney diseases, such as IgA nephropathy, hypertensive benign arteriolar nephrosclerosis, and diabetic nephropathy; 3. Those who had taken or were taking hormones or immunosuppressants in the recent (3 months), or those who violated the protocol of this study; 4. Patients with abnormal indicators of other rheumatic immune diseases; 5. Persistent bacterial or viral infection, such as active hepatitis B and persistent abnormal liver function; 6. Anyone with a history of malignant tumor, HIV infection, mental illness, acute central nervous system diseases and serious gastrointestinal diseases; 7. combined with life-threatening complications such as severe infection, 8. Patients with cardiovascular diseases (such as coronary heart disease), arrhythmia, cerebrovascular diseases (such as cerebral hemorrhage and cerebral infarction), or with severe organ diseases and dysfunction (including but not limited to pulmonary heart disease, cardiac insufficiency, and hepatic insufficiency); 9. Those who are known to be allergic to the components of the applied traditional Chinese medicine granules; 10. Pregnant or lactating women, or athletes; 11. Other clinical trial studies are being conducted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24h UP; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum PLA2R1 antibody;TCM Symptom Score;Serum Albumin;KDQOL-SFTM 1.3 Score; | — |
Countries
China
Contacts
Public ContactHongliang Rui
Beijing Hospital of TCM
Outcome results
None listed