💬In plain words
What the trial is, and whether it could suit you
1. Study Design This is a single-center, prospective, randomized, controlled, exploratory clinical trial. The study is designed to evaluate and compare the efficacy and safety of two biologic-based induction regimens against standard of care (SOC) and a triple-combination regimen in patients with active proliferative lupus nephritis (LN).
2. Study Objectives Primary Objective: To compare the 6-month complete renal response (CRR) rate among patients receiving biologic-based induction therapy, SOC induction therapy, and triple-combination induction therapy.
Secondary Objectives: To compare the rates of partial renal response (PRR) and overall renal response (ORR) at monthly intervals up to Month 6; to assess the time to achieve CRR/PRR; to evaluate changes in clinical and immunological parameters from baseline; and to compare the safety profiles of the three treatment regimens.
3. Key
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* 1.Signed written informed consent form. 2.Age 14-65 years (inclusive), any gender. 3.Meets the American College of Rheumatology (ACR) SLE diagnostic criteria (1997).
4.All patients have biopsy-confirmed class III/IV ± V LN within the past six months.
5.SLE-DAI score \> 6. 6.Urine protein quantification \> 1.0 g/d.
Exclusion Criteria:
* 1.Estimated glomerular filtration rate (eGFR) ≥45 ml/min/1.73 m². 2.Patients who have received renal replacement therapy, plasma exchange, immunoadsorption, or high-dose intravenous immunoglobulin (100g) within the past 2 months.
3.Patients with concomitant critical organ damage or lupus crisis (e.g., pulmonary hemorrhage, encephalopathy, heart failure) deemed unsuitable for clinical trial participation by the investigator.
4.Hematological abnormalities: White blood cells \<3000/μL, absolute neutrophil count \<1500/μL, or lymphocytes \<800/μL, platelet count \<50,000/μL (unless due to SLE activity).
5.Liver function abnormalities: ALT, AST, or bilirubin levels exceeding 2 times the upper limit of normal.
6.Known allergy or contraindication to any component of belimumab and/or telitacicept.
7.Active infection or intravenous antibiotic use within 1 month prior to enrollment.
8.Pregnant or breastfeeding women. 9.Current or within the past 3 months: Active hepatitis B, hepatitis C, tuberculosis, cytomegalovirus pneumonia, active fungal infection, syphilis infection, or HIV infection; active peptic ulcer; history of drug abuse or alcoholism; severe malnutrition (BMI \<16 kg/m²).
10.Other conditions: Severe cardiovascular disease potentially life-threatening; chronic obstructive pulmonary disease, or asthma/allergic diseases requiring long-term oral steroid treatment; malignant hypertension; history of malignancy within the past 5 years (except for completely treated basal cell or squamous cell skin cancer or cervical intraepithelial neoplasia).
11.Other situations deemed unsuitable for enrollment by the investigator.
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