Safety Issues Clinical Trial
— BEAMOfficial title:
Clinical Trial of Belimumab Combined With Multi-target Induction Therapy in Adult Patients With Severe Lupus Nephritis
The goal of this single-center, prospective clinical trial is to test the safety and efficacy of belimumab combined with multi-target therapy in the treatment of severe lupus nephritis. The main questions it aims to answer are: lupus nephritis complete remission rate at week 24, and the partial remission rate and safety assessments. Patients with severe lupus nephritis will be enrolled and received pulse methylprednisolone at a dose of 1.5 to 3.0g, followed by intravenous belimumab at a dose of 10mg per kilogram at weeks 2, 4, and 6, and every 4 weeks thereafter. Multitarget therapy will be also administered during the induction phase. Induction therapy will last for 24 weeks. Patients with severe lupus nephritis who only received multi-target therapy during the same period will be enrolled as the control group.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | December 31, 2024 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 65 Years |
Eligibility | Inclusion Criteria: - Active LN in accordance with the American College of Rheumatology (ACR) diagnostic criteria for SLE (1997), SLE-DAI>10 points (except type ? LN). - Patients with active lupus nephritis (type ?, ?, ?, ?+?, ?+?) diagnosed by light microscopy, immunofluorescence microscopy, and electron microscopy according to the ISN/RPS2003 lupus nephritis classification criteria, with pathological chronicity index (CI) less than 3 points and no TMA like changes in interstitial vessels. - Proteinuria =1.5g/24h, with or without active urinary sediment (urinary sediment red blood cell count >100/ul, or white blood cell count >5 /HP, or red blood cell cast, excluding urinary tract infection). - Serum creatinine <3.0mg/dL or eGFR<30 ml/min/1.73m^2 (CKD-EPI formula). - Received methylprednisolone pulse therapy within 2 weeks before enrollment, cumulative dose 1.5-3.0g). Exclusion Criteria: - Required renal replacement therapy or received renal replacement therapy within 3 months. - Abnormal liver function with elevated ALT, AST or bilirubin more than 2 times the upper limit of normal. - Abnormal glucose metabolism, defined as fasting blood glucose concentration =7.0mmol/L and/or 2-hour postprandial blood glucose concentration >11.1mmol/L. - Mycophenolate mofetil, cyclophosphamide, tacrolimus, cyclosporine A, and high-dose intravenous immunoglobulin (IVIG) were used in the past 12 weeks; It did not include oral hormones, azathioprine or tripterygium wilfordii polyglycosides, or intravenous low-dose MP (less than 80mg/ day), or short-term use of cyclosporine A<2 weeks, or leflunomide <4 weeks. - Known allergy to or contraindication to MMF, tacrolimus, or belimumab; Patients with active infection or intravenous antibiotic use within 1 month before admission. - Current or past 3 months: active hepatitis B, hepatitis C, tuberculosis, cytomegalovirus pneumonia, active fungal infection, syphilis infection or HIV infection, etc.; Active peptic ulcer; A history of drug use and alcohol abuse; Severe malnutrition (BMI<16 kg/m^2). - Other active diseases, such as severe life-threatening cardiovascular diseases; Chronic obstructive pulmonary disease, or asthma requiring treatment with oral steroids; Bone marrow suppression caused by SLE activity was excluded: WBC<3000/ul, absolute neutrophil count <1300/ul, and platelet count < 50 000/ul. Patients with active SLE who received double plasma filtration, plasma exchange or high-dose gamma globulin therapy within 4 weeks. - Patients with malignant hypertension. - Women who have fertility requirements, refuse contraception or are lactating. - Other investigators considered that they were not suitable for enrollment and may have rapid disease progression or severe disease complications. |
Country | Name | City | State |
---|---|---|---|
China | Jiong Zhang | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Nanjing University School of Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients with a cumulative complete response at week 24 of treatment. | Complete response will be defined as below:
urinary protein less than 0.4g/24h no active urinary sediment serum albumin more than 3.5g/dl and normal SCr. |
24 weeks | |
Secondary | The proportion of patients with partial response and non-response to treatment. | Partial response will be defined as a decrease of more than 50% of the baseline value of urinary protein and less than 3.5g/24h of urinary protein, a decrease of more than 50% of the baseline value of urinary sediment red blood cell count, and a normal or an increase of less than 30% of serum creatinine | 24 weeks | |
Secondary | Overall response rate at 24 weeks. | These will include complete remission and partial remission | 24 weeks | |
Secondary | Improvement of clinical indicators. | Clinical improvement of the disease was assessed using systemic lupus erythematosus disease activity index. | 24 weeks | |
Secondary | The changes of B cells. | The changes of CD20 number in peripheral blood will be observed and investigated. | 24 weeks |
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