Belimumab In Prevention of LN

Launched by RENJI HOSPITAL · Oct 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called belimumab can help prevent kidney problems in patients with systemic lupus erythematosus (SLE), which is an autoimmune disease that can affect various parts of the body, especially the kidneys. The goal is to see if giving belimumab to people who are at high risk of developing lupus nephritis (a serious kidney condition) can reduce their chances of developing this problem over the next two years. Patients eligible for this trial must be at least 18 years old, meet specific criteria for SLE, and have a greater than 50% risk of developing lupus nephritis according to a prediction model.

Participants will need to be on stable medications for their lupus and be willing to follow the study guidelines, including using contraception during the trial. They will be monitored closely to see how well belimumab works in preventing kidney issues. It's important to know that patients with previous kidney problems or certain other health conditions will not be eligible for this study. This trial is not yet recruiting participants, but it aims to provide valuable insights into how to better manage the health of those with SLE and protect their kidneys.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged ≥ 18 years old;
• • Meet the 1997 revised American College of Rheumatology criteria for Systemic Lupus Erythematosus;
• • 2-year risk of developing new-onset lupus nephritis higher than 50% (50%\~100%) based on our AI-constructed prediction model.
• • Patients received a stable SOC regimen with fixed doses of prednisone (0-40mg/day), and/or hydroxychloroquine, and/or immunosuppressive agents (azathioprine, mycophenolate, methotrexate, ciclosporin, tacrolimus, leflunomide) for at least 30 days before the study.
• • Be willing to join the trial and sign the written informed consent.
• • Contraception is required during the study.
• Exclusion Criteria:
• • -- Patients with previous kidney involvement were excluded;
• Definition of previous kidney involvement:
• • Kidney biopsy confirmed; or
• * Active urinary sediment defined as any one of the following:
• • A. \>5 RBC/hpf in the absence of menses and infection; B. \>5 White blood cell per high powered field (WBC/hpf) in the absence of infection; or Cellular casts limited to RBC or WBC casts.
• • C. 24-hour urine protein \> 0.5g
• • Severe active lupus such as neuropsychiatric lupus or cardiac involvement were excluded from the trial;
• • Pregnancy or lactation;
• • Previous treatment with any B-lymphocyte-targeted drug (including rituximab), intravenous cyclophosphamide within 6 months of enrolment, and intravenous Ig or prednisone (\>100 mg/day) within 3 months.
• • Hepatic (ALT or AST \> 2 times upper normal limits) or renal dysfunction (creatinine clearance rate \< 60 ml/min).
• • Have a history of a primary immunodeficiency
• • Have a significant IgG deficiency (IgG level \< 400 mg/dL)
• • Have an IgA deficiency (IgA level \< 10 mg/dL)
• * Infection history:
• • Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria)
• • Hospitalization for treatment of infection within 60 days of Day 0.
• • Use of parenteral (IV or IM) antibiotics (anti-bacterial, antiviral, anti-Fungal, or anti-parasitic agents) within 60 days of Day 0
• • Serologic evidence of current or past Hepatitis B (HB) infection based on the results of testing for HBsAg and HBcAb
• • Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies
• • Have a historically positive HIV test or test positive at screening for HIV
• • Have any other clinically significant abnormal laboratory value in the opinion of the investigator
• • Have any intercurrent significant medical or psychiatric illness that the investigator considers would make the candidate unsuitable for the study
• • Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 365 days prior to Day 0
• • Excluded Concomitant Medications
• * Anti-B-cell therapy:
• • Wash-out of 5 therapeutic half lives after prior B-cell therapy, or until pharmacodynamic effect would be minimal (e.g., 1 year following rituximab)
• * 365 days prior to belimumab:
• • Any biologic investigational agent (e.g., abetimus sodium, anti CD40L antibody, BG9588/ IDEC 131)
• * 90 days prior to belimumab:
• • Intravenous cyclophosphamide
• • Subjects who receive CYC whose leukocyte count is \<2000/m3
• • 30 Days Prior to belimumab (or 5 half-lives, whichever is greater) o Any non-biologic investigational agent
• • Live vaccines within 30 days prior to baseline or concurrently with belimumab