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Compares treatment options for Systemic Lupus Erythematosus (SLE)
Official title The Efficacy and Safety of Biologics (Belimumab/ Telitacicept) Induction Therapy in Proliferative Lupus Nephritis Patients for 6 Months Compared With Mycophenolate Mofetil Treatment
ClinicalTrials.gov ID: NCT07340463
What this study is testing
What is Glucocorticoids?
Glucocorticoids is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for systemic lupus erythematosus (sle).
Also referred to as Corticosteroids.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 1. Study Design This is a single-center, prospective, randomized, controlled, exploratory clinical trial.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 65
You may be able to join if
- 1.Signed written informed consent form. 2.Age 14-65 years (inclusive), any gender. 3.Meets the American College of Rheumatology (ACR) SLE diagnostic...
- 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.
You likely can't join if
- 1.Estimated glomerular filtration rate (eGFR) ≥45 ml/min/1.73 m². 2.Patients who have received renal replacement therapy, plasma exchange...
- 3.Patients with concomitant critical organ damage or lupus crisis (e.g., pulmonary hemorrhage, encephalopathy, heart failure) deemed unsuitable for...
- 4.Hematological abnormalities: White blood cells \<3000/μL, absolute neutrophil count \<1500/μL, or lymphocytes \<800/μL, platelet count \<50,000/μL...
- 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.
See the full eligibility 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.
- 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...
- 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...
- 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...
- 11.Other situations deemed unsuitable for enrollment by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.