primary membranous nephropathy
Conditions
Interventions
experimental group:rituximab +steroids
control group:rituximab + tacrolimus
Sponsors
Xijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-80; 2. PMN was confirmed by renal biopsy, or the clinical manifestations were nephrotic syndrome and strong positive PLA2R antibody (titer > 20 RU/ mL); 3. After at least three months of angiotensin converting enzyme inhibitor/angiotensin receptor blocker (ACEI/ARB) treatment with uroalbumin (blood pressure control target 3.5 g/d (at least twice within 14 days). Serum albumin = 30 mL /min/1.73 m2 (ckD-EPI method, including age, sex and serum creatinine); 4. Did not receive glucocorticoid or monocorticoid treatment within one month before enrollment; No alkylating agents or calcineurin inhibitors were taken in the first six months
Exclusion criteria
Exclusion criteria: 1. Secondary membranous nephropathy (systemic lupus erythematosus, B virus-associated nephropathy, henoch Schonlein Purpura nephritis, drug therapy, malignant tumor and other membranous nephropathy); 2. Serum immunoglobulin IgG < 4g/L at enrollment; 3. Other diseases: diabetes mellitus or impaired glucose tolerance; HBV serological index is positive. Congenital or acquired immunodeficiency; Active infection or clinical evidence of active tuberculosis or active cytomegalovirus infection; A history of peptic ulcer and/or gastrointestinal bleeding; Granulocytopenia, thrombocytopenia; Has had a malignant tumour in the past 5 years; Congenital heart disease, arrhythmia, heart failure, and other serious cardiovascular diseases; Serious mental illness; 4. Women of childbearing age are pregnant, have failed to use contraception, or are breastfeeding; Inability or unwillingness to use appropriate contraceptive methods; 5. Drug resistance history of CNI, RTX, or alkylating agents; Either the response to CNI, RTX, or alkylating agents, that is, complete or partial remission of proteinuria, but recurrence within three to six months; 6. Participated in other clinical trials within three months prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete remission;partial remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| treatment failure;relapse; | — |
Countries
China
Contacts
Public ContactLijie He
Xijing Hospital
Outcome results
None listed