membranous nephropathy
Conditions
Interventions
Experimental Group:Stage 1: 12-week treatment with Rituximab combined with low-dose steroids (prednisone 10-15 mg/day). Stage 2: 12-week treatment with Busi Yishen Granules combined with Shenling Baiz
Placebo control group:Stage 1: 12-week treatment with rituximab combined with low-dose corticosteroids (10-15 mg/d)
Stage 2: 12-week treatment with Bu Shen Yi Shen Granules combined with Shen Ling Bai Zhu Powder Capsules placebo.
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Confirmed pathological type as membranous nephropathy by kidney biopsy or anti-phospholipase A2 receptor antibody (PLA2R antibody) >50 RU/ml; 2) Urinary protein quantification >3.5 g/24h; 3) eGFR (CKD-EPI formula) =30 ml/min/1.73m²; 4) Age between 18-80 years; 5) Signed informed consent.
Exclusion criteria
Exclusion criteria: (1) Membranous nephropathy-like kidney pathological damage caused by secondary factors; (2) Extremely high-risk membranous nephropathy: manifested as life-threatening nephrotic syndrome or unexplained rapid deterioration of renal function; (3) Combined severe primary diseases of the respiratory, circulatory, or hematological systems, or mental disorders, where conventional medications are ineffective, such as severe heart failure (NYHA class IV); severe water, electrolyte, and acid-base balance disorders; (4) Primary or secondary immunodeficiency, severe impairment of immune response (e.g., serum immunoglobulin IgG 2.5 times the upper limit of normal; (10) Patients currently participating in other drug clinical trials; (11) Women who are planning pregnancy within the next six months, are pregnant, or are breastfeeding; (12) Patients deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first relapse; | — |
Secondary
| Measure | Time frame |
|---|---|
| The difference in the proportion of participants with immunological relapse between groups;The intergroup difference in the proportion of patients with clinical recurrence;The time from the initial administration of rituximab to achieving immunological remission.;The intergroup difference in the proportion of patients achieving immunological remission;The differences in the proportion of participants achieving immune response remission, clinical partial remission, and clinical complete remission;The difference in the proportion of participants achieving immunological remission, clinical partial remission, or clinical complete remission; | — |
Countries
China
Contacts
Public ContactZhang La
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed