membranous nephropathy
Conditions
Interventions
Sponsors
Xinqiao Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The patient was definitely diagnosed with type 2 DM, according to the 2019 American diabetes association standard a. At the same time, the pathological diagnosis of the renal biopsy was membranous nephropathy b, and the typical pathological features of MN were the deposition of renal subepithelial immune complex and the thickening of glomerular capillary loops. Pathological staging: I period, glomerular basement membrane (GBM) basic normal, no obvious thickening foot process widely, "convergence" GBM lateral epithelial exploits piece of electron-dense deposit; II period, GBM diffuse thickening of glomerular epithelial cells under the most orderly electron dense deposit, between them has GBM reactive hyperplasia of spikes; III period, in the glomerular basement membrane hyperplasia of the electron dense GBM surround, mesangial matrix hyperplasia, some began to be absorbed and not consistent with the size, shape, density of electron-dense and bright area; IV period, electron-dense dissolve absorption of the different parts of the deposit, the basement membrane is an irregular insect that eats the sample; V period: basic normal glomerular morphology. Other secondary renal diseases were excluded. (a: according to the Standards of Medical Care in Diabetes 2019, Diabetes Care 2019 Jan; B: according to the diagnostic criteria of the international society of nephrology/Pathology for Membranous Nephropathy, Fogo AB, Lusco MA, Najafian b, Alpers CE. AJKD Atlas of Renal Pathology: Nephropathy. Am J Kidney Dis 2015; 66: e15); 2. The patient volunteered and agreed to participate in the study (signed informed consent); 3. Patients can understand the study procedures and follow them throughout the study period; 4. Over 18-80 years old; 5. Primary MN confirmed by renal biopsy; 6. EGFR >= 45ml/ min / 1.73m2 was measured during the screening period (within 30 days after the informed consent was signed); 7. During the screening period, the albuminuria ration of > 4 g/day (no reduction of > 50% in the last 6 months) was accompanied by hypoproteinemia <= 35g/L.
Exclusion criteria
Exclusion criteria: 1. HIV infection; 2. Moderate or severe liver disease (AST and ALT > 2.5 times the upper limit range and total bilirubin > 1.5 times the upper limit range); 3. The patient participates in any other study and has been studied and/or received or has received another study drug or intervention (within the first month prior to signing the informed consent); 4. Known or suspected of rituxan, ring spore, tacrolimus, corticosteroids, cyclophosphamide or any of its ingredients (and any other drugs from the same drug treatment group (namely neural phosphatase inhibitor of calmodulin, specificity monoclonal antibody hypersensitivity, history of allergies and/or immunogenicity reaction antibody or alkylating agent); 5. Treatment with corticosteroids within the first three months of screening, or with other immunosuppressive agents within the first six months of screening, and rituximab or any other biologic agent within two years of screening; 6. Patients who did not respond to previous immunosuppressive agents; 7. Women who were positive for a pregnancy test during screening or lactation or who planned to become pregnant within 24 months, or who were unwilling to use contraceptive methods throughout the study period; 8. Current dependence on drug or alcohol use.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete remission;partical remisison;No remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of recurrent patients; | — |
Countries
China
Contacts
Public ContactJinghong Zhao
Xinqiao Hospital
Outcome results
None listed