Microscopic polyvasculitis
Conditions
Interventions
Experimental group:Oral mycophenol sodium enteric-coated tablet
control group: cyclophosphamide
Sponsors
Shanxi Medical University Second Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age>=18 years old, regardless of gender; 2. According to the definition of the 2012 Chapel Hill Consensius Conference, the clinical diagnosis is MPA, which can be initial or recurrent; 3. MPO-ANCA positive; 4. Active MPA: In the BVAS score version 3.0 (Appendix 1), there is at least one main entry, or at least three other entries, and it is clinically determined that CYC treatment is required; 5. Non life threatening MPA: MPA that does not meet exclusion criteria 2 (severe illness); 6. All subjects and their partners should have no parenting plan during the trial period until 6 months after the end of the trial, and agree to take appropriate contraceptive measures; 7. Prior to conducting any specific procedures related to this study, a written informed consent form was signed.
Exclusion criteria
Exclusion criteria: 1. Restrictive diseases: Subjects who are determined by the researchers to not require CYC treatment according to diagnostic and treatment routines; 2. Severe diseases: 1) Severe life-threatening vasculitis (including diffuse alveolar bleeding, respiratory failure, intestinal perforation or massive bleeding, cerebral vasculitis, cardiac vasculitis, etc.); 2) Rapid progressive glomerulonephritis with rapid decline in renal function: defined as a decrease of eGFR by>20% within two weeks (see Appendix 2 for the eGFR evaluation formula); 3) EGFR< 15 ML/min/1.73m2 or dialysis treatment has started; 3. For acute infectious diseases or chronic/recurrent infectious diseases (such as hepatitis B, hepatitis C and tuberculosis), HBsAg, HCV Ab, HIV Ag/Ab or Treponema pallidum antibody test results are positive; 4. Confirmed or suspected malignant tumors; 5. Any other multisystem autoimmune diseases, including eosinophilic granulomatous vasculitis, GPA, systemic lupus erythematosus, anti glomerular basement membrane disease, and cryoglobulinemia. 6. Active severe digestive system diseases (such as gastrointestinal bleeding, inflammatory bowel disease, etc.); 7. Serious, progressive or uncontrolled diseases in important organs and organs (heart, lungs, liver, brain); 8. Laboratory examination: Glutamate transaminase and/or Glutamate transaminase are more than twice the normal upper limit (judged not to be caused by vasculitis), and leukopenia or thrombocytopenia (lower than the normal lower limit); 9. MMF or EC-MPS: Oral administration for at least 2 weeks within 8 weeks; 10. CYC: Oral administration for at least 2 weeks per day within 12 weeks, or intravenous injection at least once; 11. Rituximab: Used within 12 months; 12. Pregnant or lactating women; 13. Participated in clinical trials of other drugs within three months before the first administration; 14. Known allergies or intolerance to drugs such as MMF, EC-MPS, AZA, or CYC; 15. Other diseases or conditions that the researcher deems unsuitable for participation in this experiment.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Sustained response rate of MPA at 18 months after induction of remission with oral EC-MPS; | — |
Primary
| Measure | Time frame |
|---|---|
| Complete response rate of MPA at 6 months after induction of remission with oral EC-MPS; | — |
Countries
China
Contacts
Public ContactXiaole Su
Shanxi Medical University Second Hospital
Outcome results
None listed