lupus nephritis
Conditions
Interventions
Belimumab (BLM) group:None
Telitacicept(TACI) group:None
Sponsors
The First Affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Patients with active SLE must meet at least four of the eleven criteria established by the American College of Rheumatology in the 1997 revised classification for SLE at the time of diagnosis. (2) Participants must be aged between 18 and 65 years old, with no restrictions on gender or gender ratio. (3) Inpatients or outpatients with good compliance, all of whom have signed informed consent forms. (4) A SLEDAI (Systemic Lupus Erythematosus Disease Activity Index) score of >= 8 during the screening period. The clinical symptoms related to SLEDAI (excluding low complement and/or anti-ds-DNA antibodies) should have a score of >= 6 when scores for low complement and/or anti-ds-DNA antibodies exsisting. (5) Positive results in serological tests for autoantibodies, defined as a positive ANA (Antinuclear Antibody) and/or anti-ds-DNA antibody result based on the reference range set by the research center laboratory. Borderline results will not be accepted; (6) All patients must have a kidney biopsy performed within the last six months confirming the diagnosis of either type III or IV (only A and A/C), with or without concomitant type V, or pure type V active lupus nephritis.
Exclusion criteria
Exclusion criteria: (1) Renal diseases: Active non-lupus nephritis renal inflammation; (2) Active hepatitis or history of severe liver disease or illness. For hepatitis B: Exclude patients with positive HBsAg (Hepatitis B Surface Antigen). Patients with negative HBsAg but positive HBcAb (Hepatitis B Core Antibody) need to undergo HBV-DNA testing to clarify their condition: if HBV-DNA is positive, the patient is excluded and cannot participate in the study; if HBV-DNA is negative, the patient may participate in the study. For hepatitis C: Exclude patients with positive hepatitis C antibody; (3) Immunodeficiency, uncontrolled severe infection, and active or recurrent gastrointestinal ulcers; (4) Pregnant women, lactating women, and male or female subjects who plan to conceive during the trial period; (5) Allergic reactions: History of allergy to human-derived biologics; (6) Individuals who received live vaccines within 28 days prior to using the biologic agent; (7) Participation in any clinical trial within 28 days before using the biologic agent or within five times the half-life of the investigational drug used in a previous clinical trial (whichever is longer); (8) Use of B-cell targeted therapy drugs (such as rituximab or epratuzumab) or tumor necrosis factor inhibitors, interleukin receptor blockers within 12 months before using the biologic agent; (9) Use of intravenous immunoglobulin (IVIG), prednisone >= 100 mg/day or equivalent corticosteroid treatment for >= 14 days, or undergoing plasmapheresis within 28 days before using the biologic agent; (10) Use of interleukin-2, thalidomide within 28 days before using the biologic agent; (11) Active infection during the screening period (e.g., herpes zoster, HIV infection, active tuberculosis, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Renal response rate ; | — |
Secondary
| Measure | Time frame |
|---|---|
| SRI4 response rate;Complete renal response rate;Percentage of subjects with >= 25% reduction in glucocorticoids dose from baseline;urine protein ;Proportion of patients with prednisone dose <= 7.5 mg/ day;serum creatinine;SLE disease activity index (SLEDAI-2k) score; | — |
Countries
China
Contacts
Public ContactHanyou Mo
The First Affiliated Hospital of Guangxi Medical University
Outcome results
None listed