Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001789
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
BG9588 Anti-CD40L Antibody to Treat Lupus Nephritis
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
An Open-Label Multiple-Dose Study to Evaluate the Efficacy Safety and Pharmacokinetics of BG9588 Anti-CD40L Antibody in Subjects With Proliferative Lupus Glomerulonephritis SLE-GN
Status:
COMPLETED
Status Verified Date:
1999-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate whether the experimental drug BG9588 can be used to treat lupus nephritis more effectively and with less toxicity than standard treatments including cyclophosphamide Cytoxan azothioprine Imuran and prednisone
The bodys immune system naturally produces antibodies to fight foreign substances like bacteria and viruses In autoimmune diseases like lupus however the body makes antibodies that attack its own tissues causing inflammation and organ damage Lupus antibodies attack and damage kidney cells BG9588 can interfere with the production of these antibodies and therefore may lessen kidney damage in people with lupus nephritis
This study will look at how BG9588 enters and leaves the blood and body tissue over time adverse effects of the drug and whether treatment with BG9588 can result in less kidney damage than other therapies
Study patients will be receive a 30-minute infusion of BG9588 into a vein every two weeks for three doses and then once every 28 days for four doses Patients steroid dosage may be tapered individual adjustments will be made as required
Patients screened for the study will undergo a physical examination medical history various blood and urine tests as well as complete a quality of life questionnaire Results of a previous kidney biopsy and chest X ray are also required Many of these tests will be repeated throughout the study
In a previous animal study BG9588 treatment of mice with lupus nephritis improved their disease and survival
The bodys immune system naturally produces antibodies to fight foreign substances like bacteria and viruses In autoimmune diseases like lupus however the body makes antibodies that attack its own tissues causing inflammation and organ damage Lupus antibodies attack and damage kidney cells BG9588 can interfere with the production of these antibodies and therefore may lessen kidney damage in people with lupus nephritis
This study will look at how BG9588 enters and leaves the blood and body tissue over time adverse effects of the drug and whether treatment with BG9588 can result in less kidney damage than other therapies
Study patients will be receive a 30-minute infusion of BG9588 into a vein every two weeks for three doses and then once every 28 days for four doses Patients steroid dosage may be tapered individual adjustments will be made as required
Patients screened for the study will undergo a physical examination medical history various blood and urine tests as well as complete a quality of life questionnaire Results of a previous kidney biopsy and chest X ray are also required Many of these tests will be repeated throughout the study
In a previous animal study BG9588 treatment of mice with lupus nephritis improved their disease and survival
Detailed Description:
Studies in animals and humans with lupus nephritis have demonstrated that essential role of CD40 ligandCD40 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 CD40LCD40 interaction between T and B cells that is required for the initiation for certain antibody responses Available preclinical data indicates that BG9588 does not cause a global blockage of the immune response to pathogens and that its effects are reversible upon clearance from the systemic circulation In this Phase III open-label multiple-dose multicenter study 30 subjects with active proliferative lupus nephritis will receive 20 mgkg BG9588 by IV infusion once every 14 days for three doses and then once every 28 days for four doses for a total of 7 doses The primary objective is to determine if BG9588 can decrease proteinuria by greater than or equal to 50 percent from baseline without worsening renal function The secondary objectives are to determine the safety and pharmacokinetics of BG9588 as well as the effects of BG9588 on renal flares cellular casts C3 levels and anti-dsDNA titers requirement for prednisone general lupus activity and quality of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-AR-0133 | None | None | None |