ANCA-associated Glomerulonephritis
Conditions
Interventions
treatment group:Telitacicept 160 mg subcutaneously once weekly for 24 weeks. Glucocorticoids should be used and tapered according to the KDIGO 2024 guideline for ANCA?associated vasculitis, or based o
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. According to the 2022 EULAR/ACR guidelines, newly diagnosed or relapsed ANCA-associated vasculitis (AAV) includes microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA); 2. Concurrent active renal damage caused by AAV: renal biopsy findings consistent with necrotizing glomerulonephritis/oligoimmunocomplex crescentic glomerulonephritis; or red blood cell casts; or hematuria [=30 RBC/HPF], with or without elevated serum creatinine; 3. Baseline serum creatinine < 3.0 mg/dL (265 µmol/L); 4. MPO-ANCA or PR3-ANCA positive; 5. Age = 18 years; 6. Patients with contraindications to standard regimens, or who cannot tolerate them, or who have significant concerns regarding the side effects of conventional regimens and voluntarily refuse conventional treatment after thorough discussion; 7. Patients with independent decision-making capacity and sufficient comprehension to understand and cooperate with the study; 8. Patients or their authorized representatives who understand the study protocol, are willing to participate in the study, and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: Patients will not be eligible for inclusion in the clinical study if they meet any of the following criteria: 1. Renal involvement is expected to progress rapidly, serum creatinine is likely to exceed 3.0 mg/dL (265 µmol/L) in the short term, or a renal biopsy is consistent with crescentic glomerulonephritis, or there are severe AAV-related complications such as alveolar hemorrhage; 2. Have received any of the following treatments: a. Use of B-cell depleting agents (e.g., rituximab, obinutuzumab, belimumab, etc.) within the past 6 months; b. Use of alenumab or anti-thymocyte globulin (ATG) within the past 12 months; c. Use of infliximab, etanercept, adalimumab, or abatacept within the past 3 months; d. Use of immunosuppressants within the past 1 month, including but not limited to: cyclophosphamide, azathioprine, mycophenolate, leflunomide, tacrolimus, cyclosporine, or Tripterygium wilfordii; 3. Significant or uncontrolled diseases unrelated to AAV; 4. Presence of another multisystem autoimmune disease, including systemic lupus erythematosus, anti-GBM disease, or cryoglobulinemia; 5. Hepatitis B or C, HIV infection, or active tuberculosis; 6. Patients diagnosed with malignancy within the past 5 years, except for treated basal cell carcinoma of the skin, effectively resected squamous cell carcinoma of the skin, colorectal polyps, or cervical carcinoma in situ; 7. Active infections requiring intravenous antimicrobial therapy; 8. Patients with hypersensitivity to tecasip; 9. Patients who have received a live vaccine within the past month; 10. History of drug or alcohol abuse/dependence within 52 weeks prior to randomization; 11. Laboratory-related exclusion criteria: bone marrow suppression (manifested as a total white blood cell count 2.5 times the upper limit of normal, unless attributable to vasculitis; 12. Pregnant women, lactating women, and men or women planning to conceive during the trial; 13. Participants currently enrolled in other clinical trials; 14. eGFR < 15 mL/min for more than 3 months; 15. Any concomitant condition for which treatment with oral systemic glucocorticoids, immunosuppressants, biologics, plasma exchange, or intravenous immunoglobulin is anticipated; 16. Any other reason determined by the investigator to render the participant unsuitable for this clinical trial, in addition to those listed above.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complement remission;drug side effects; | — |
Secondary
| Measure | Time frame |
|---|---|
| Partial remission rate; Time to remission ;Change in estimated glomerular filtration rate;relapse;death;End-stage renal disease; | — |
Countries
China
Contacts
Public ContactLimeng Chen
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed