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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05863936
Other study ID # NJCT-2023
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date April 1, 2023
Est. completion date December 31, 2024

Study information

Verified date May 2023
Source Nanjing University School of Medicine
Contact Jiong Zhang, PhD
Phone 86-25-80862860
Email jiongzhang@live.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Methylprednisolone Injectable Suspension
Methylprednisolone pulse therapy, total dose from 1500mg to 3000mg.
Belimumab Injection
Belimumab at a dose of 10mg per kilogram at weeks 2, 4, and 6, and every 4 weeks for 24 weeks.
Immunosuppressive Agents
Mycophenolate Mofetil, oral, 1.0-1.5g per day; Tacrolimus, oral, 2-4mg per day.

Locations

Country Name City State
China Jiong Zhang Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Nanjing University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

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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