- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001789
BG9588 (Anti-CD40L Antibody) to Treat Lupus Nephritis
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)
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 body's 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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 990133
- 99-AR-0133
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lupus Nephritis
-
Imperial College LondonKarolinska Institutet; Ohio State University; Dutch Working Party on Systemic... and other collaboratorsTerminatedSystemic Lupus Erythematosus, Lupus NephritisUnited Kingdom
-
Sun Yat-sen UniversityCompleted
-
Peking UniversityCompleted
-
University Hospital, GrenobleInstitut de Biologie Structurale GrenobleCompletedSystemic Lupus Erythematosus NephritisFrance
-
Peking Union Medical College HospitalUnknownNephritis, LupusChina
-
Artiva Biotherapeutics, Inc.RecruitingLupus Nephritis - WHO Class IV | Lupus Nephritis - WHO Class IIIUnited States
-
Kyverna TherapeuticsRecruitingLupus Nephritis | Lupus Nephritis - WHO Class IV | Lupus Nephritis - WHO Class IIIGermany
-
Minia UniversityNot yet recruitingmfERG in Lupus NephritisEgypt
-
Kyverna TherapeuticsRecruitingLupus Nephritis | Lupus Nephritis - World Health Organization (WHO) Class III | Lupus Nephritis - WHO Class IVUnited States
-
Centre Hospitalier Universitaire, AmiensCompletedLupus Nephritis | Systemic Lupus Erythematosus (SLE)France
Clinical Trials on BG9588
-
National Institute of Diabetes and Digestive and...CompletedKidney TransplantationUnited States