Elderly ANCA-associated glomerulonephritis
Conditions
Interventions
Study group:Obinutuzumab beta Combined with Glucocorticoids
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.According to the Chapel Hill Consensus Conference (CHCC) nomenclature system for vasculitides, newly diagnosed or relapsed ANCA-associated vasculitis (AAV) includes the following major subtypes: microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA). 2.Active renal involvement due to AAV, evidenced by renal biopsy showing necrotizing/pauci-immune crescentic glomerulonephritis, or RBC casts, or hematuria (>=10 RBC/HPF), with or without elevated serum creatinine. 3.positive for MPO-ANCA or PR3-ANCA. 4.Aged 65 years or older; 5.Able to live independently, has sufficient cognitive ability, and can understand and comply with the study protocol.
Exclusion criteria
Exclusion criteria: 1.Prior treatment with any of the following: a. Treatment with a B-cell depleting agent (e.g., rituximab, obinutuzumab, belimumab, etc.) within 12 months prior to screening; or treatment within 6 months prior to screening with documented evidence of peripheral B-cell recovery (CD19+ B-cells > 10 cells/µL or above the lower limit of normal); b. Use of alemtuzumab, anti-thymocyte globulin (ATG), or receipt of hematopoietic stem cell transplantation within 12 months prior to screening; c. Treatment with intravenous immunoglobulin (IVIg) or plasma exchange (PE) within 4 weeks prior to screening; d. Use of any biologic agent targeting cytokines or other targets (e.g., infliximab, adalimumab, tocilizumab, ustekinumab, etc.) within 4 weeks (or 5 half-lives, whichever is longer) prior to screening; e. Treatment with remission-induction doses of immunosuppressive agents, including but not limited to cyclophosphamide, mycophenolate mofetil (MMF), calcineurin inhibitors, and methotrexate, for more than 2 weeks prior to screening. 2.Concomitant major or uncontrolled diseases not attributable to AAV. 3.Patients with another multi-system autoimmune disease, including but not limited to systemic lupus erythematosus, anti-GBM disease, or cryoglobulinemic vasculitis, will be excluded. 4.Hepatitis B, hepatitis C, HIV infection, or active tuberculosis infection; 5.Diagnosis of malignancy within the past 5 years, except for treated basal cell carcinoma of the skin, adequately resected squamous cell carcinoma of the skin, colonic polyps, or carcinoma in situ of the cervix; 6.Active infection requiring intravenous antimicrobial therapy; 7.Known hypersensitivity to obinutuzumabß; 8.Vaccination with a live vaccine within the past month; 9.History of drug or alcohol abuse/dependence within 52 weeks prior to enrollment; 10.Laboratory exclusion criteria: bone marrow suppression (defined as total white blood cell count 2.5 times the upper limit of normal, unless attributable to vasculitis; hypogammaglobulinemia with IgG < 3 g/L; 11.eGFR < 15 mL/min persisting for more than 3 months; 12.urrent participation in another clinical trial; 13.Any concomitant disease that is anticipated to require treatment with systemic oral glucocorticoids, immunosuppressive agents, biologic agents, plasma exchange, or intravenous immunoglobulin during the study period; 14.Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate at 24w; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Remission time;Recurrence;ESRD;eGFR at 24w;Patrial remission rate at 24w;death; | — |
Countries
China
Contacts
Public ContactChen Limeng
Peking Union Medical College Hospital
Outcome results
None listed