lupus nephritis
Conditions
Interventions
Intervention group:Administer subcutaneous injection of Telitacicept 160mg once a week for 24 weeks to patients with lupus nephritis
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Age: 18 to 65 years, regardless of gender; (2) Meets the 1997 ACR SLE classification criteria; (3) At the time of enrollment: SLEDAI-2K >= 8 points.; (4) At the time of enrollment, the urinary protein creatinine ratio was greater than 1g/g; Or 24-hour urine protein>1g/24h; Or renal biopsy confirms the presence of grade III LN (focal lupus nephritis) or grade IV LN (diffuse lupus nephritis), with or without grade V (membranous lupus nephritis); (5) ANA and/or anti dsDNA antibodies were positive upon enrollment; (6) At the time of enrollment, the standard treatment regimen (SOC) has been consistently used for at least 30 days, which refers to the use of glucocorticoids, antimalarials, nonsteroidal anti-inflammatory drugs, other immunosuppressants or immunomodulators (including azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, leflunomide, tacrolimus, cyclosporine, etc.) alone/in combination.
Exclusion criteria
Exclusion criteria: 1. Received dialysis treatment within the past 6 months or eGFR<30mL/min/1.73m^2; 2. Have neurological or psychiatric disorders caused by SLE or non SLE in the past 6 months; Or there may be serious diseases of important organs such as the heart, liver, kidneys, blood, and endocrine system; 3. acute/chronic infection within 3 months; 4. Participated in any other targeted drug therapy within the past 12 months;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| T/B cell subtypes;Routine blood test;Biochemical detection;SLE related antibodies, complement, and immunoglobulin;clinical symptoms;urine routine examination; | — |
Countries
China
Contacts
Public ContactZhao Yi
West China School of Medicine, Sichuan University
Outcome results
None listed