Trial of Belimumab Combined With Multi-target Induction Therapy in Lupus Nephritis

Launched by NANJING UNIVERSITY SCHOOL OF MEDICINE · May 8, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating the combination of a medication called belimumab with a multi-target therapy for patients suffering from severe lupus nephritis, a serious kidney condition linked to lupus. The main goals of the study are to see how effective this combination treatment is at helping patients achieve complete or partial remission from their symptoms over a 24-week period, as well as to assess the safety of the treatment. Patients in the trial will receive a high-dose steroid treatment followed by belimumab, while another group will only receive the multi-target therapy for comparison.

To be eligible for this trial, participants must be diagnosed with active lupus nephritis and meet certain health criteria, such as having specific levels of protein in their urine and kidney function within a certain range. The trial is open to all adults aged between 18 and 75 who have not recently received certain other treatments or have specific medical conditions that could complicate their care. Participants can expect to receive close monitoring and support throughout the study, helping researchers learn more about how to effectively treat this challenging condition.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Active LN in accordance with the American College of Rheumatology (ACR) diagnostic criteria for SLE (1997), SLE-DAI\>10 points (except type Ⅴ LN).
• • Patients with active lupus nephritis (type Ⅲ, Ⅳ, Ⅴ, Ⅴ+Ⅲ, Ⅴ+Ⅳ) 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.