Search / Trial NCT00001789

BG9588 (Anti-CD40L Antibody) to Treat Lupus Nephritis

Launched by NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES (NIAMS) · Dec 9, 2002

Trial Information

Current as of December 26, 2024

Completed

Keywords

Autoantibody Autoimmunity Inflammation Kidney Lymphocyte Proliferative Lupus Glomerulonephritis Sle Gn

ClinConnect Summary

Studies in animals and humans with lupus nephritis have demonstrated that essential role of CD40 ligand/CD40 interaction in the production of pathogenic autoantibodies. Anti-CD40L antibody treatment of mice with lupus nephritis ameliorates disease and improves survival. BG9588 is a recombinant humanized monoclonal antibody that specifically binds to CD40 ligand (CD40L) expressed on the surface of activated T lymphocytes and thereby blocks the CD40L/CD40 interaction between T and B cells that is required for the initiation for certain antibody responses. Available preclinical data indicates ...

Gender

ALL

Eligibility criteria

  • Must give written informed consent prior to any testing under this protocol.
  • Must be 18 years or older, inclusive, at the time of informed consent.
  • Must have a renal biopsy showing active WHO Class III, IV, or mixed membranous and proliferative SLE GN, within the 5 years prior to the first dose of study drug.
  • Must have proteinuria of greater than or equal to 1.0 g/day at both the Day-27 and day-13 evaluations.
  • Must fulfill any one the following four criteria, at each of the two screening visits (i.e., Day-27 and Day-13):
  • Anti-dsDNA antibody greater than 2x the upper limit of normal (ULN).
  • C3 complement less than 80 mg/dL.
  • Hematuria greater than 5 rbc/hpf.
  • Urinary granular or red blood cell casts.
  • Must not have any medical disorder, which in the opinion of the investigator, should exclude the subject from this study.
  • Must not have prior arterial or venous thrombosis, or history of recurrent abortion (3 or more), in the presence of anti-cardiolipin antibodies.
  • Must not have a chest x-ray with evidence of active infection or neoplasm within the 6 months prior to the first dose of study drug.
  • Must not have rapidly progressive glomerulonephritis, defined as a doubling of serum creatinine, within the 3 months prior to the first dose of study drug.
  • Must not have fibrinoid necrosis and/or cellular crescents affecting more than 25 percent of glomeruli in any renal biopsy performed within the 3 months prior to the first dose of study drug.
  • Must not have clinically significant findings for any of the following within the 4 weeks prior to the first dose of study drug: active psychiatric disease, serum creatinine greater than 2.0 mg/dL, prothrombin time (PT) greater than 1.3x control (in the absence of coumadin therapy; abnormal PT values due to anti-coagulation therapy are allowed if within the therapeutic range), AST or ALT levels greater than 3x normal, other major organ dysfunction, or serious local or systemic infection (e.g., pneumonia, septicemia).
  • Must not be positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HVC Ab), or HIV antibody at the Day-27 evaluation.
  • Must not have a mean CD4 count less than or equal to 300 microliters (mean of Day-27 and Day-13 results).
  • Must not have treatment with an antibody or other investigational drug within the 3 months prior to the first dose of the study drug.
  • Must not have any vaccination within the 4 weeks prior to the first dose of the study drug.
  • Must not have treatment with IV or oral cyclophosphamide within the 4 weeks prior to the first dose of the study drug.
  • Must not have treatment with any of the following medications within the 4 weeks prior to the first dose of study drug: IV methylprednisolone, cyclosporine or related compound, or oral prednisone (equivalent oral glucocorticoid) at a dose greater than 0.5 mg/kg/day.
  • Must not have initiation of treatment with ACE inhibitors within the 4 weeks prior to the first dose of study drug.
  • Must not have initiation of treatment with azathioprine, methotrexate or mycophenolate mofetil within the 4 weeks prior to the first dose of study drug.
  • Must not have treatment with any new oral or new IV antibiotic within the 2 weeks prior to the first dose of study drug. Subjects on prophylactic antibiotics are permitted to continue these during the study.
  • Female subjects, unless post-menopausal or surgically sterile, must use an adequate method of contraception.
  • Women must not be currently breast-feeding.
  • Must not have a positive pregnancy test in any evaluation prior to the first dose of study drug.
  • Must not be currently enrolled in any other study in which the subject is receiving any type of drug or non-drug therapy.
  • Must not have been previously dosed with BG9588.

About National Institute Of Arthritis And Musculoskeletal And Skin Diseases (Niams)

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is a pivotal component of the National Institutes of Health (NIH) dedicated to advancing research and knowledge in the fields of arthritis, musculoskeletal disorders, and skin diseases. NIAMS sponsors a wide range of clinical trials aimed at improving the diagnosis, treatment, and prevention of these conditions. By fostering innovative research, collaborating with healthcare professionals, and engaging with patient communities, NIAMS strives to enhance the quality of life for individuals affected by these diseases, while promoting scientific discovery and public health initiatives.

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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