Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00035308
Status:
COMPLETED
Last Update Posted:
2006-09-25
First Post:
2002-05-02
Brief Title:
Safety and Efficacy Study of LJP 394 Abetimus Sodium to Treat Lupus Kidney Disease
Sponsor:
La Jolla Pharmaceutical Company
Organization:
La Jolla Pharmaceutical Company
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Multicenter Safety and Efficacy Trial of LJP 394 in Systemic Lupus Erythematosus SLE Patients With a History of Renal Disease
Status:
COMPLETED
Status Verified Date:
2002-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether LJP 394 abetimus sodium is safe and effective in delaying and reducing renal flares in patients with lupus nephritis
Detailed Description:
LJP 394 abetimus sodium is a unique drug that is specifically designed to lower production of antibodies to double-stranded DNA These antibodies are believed to contribute to kidney damage in patients with Systemic Lupus Erythematosus SLE Rising levels of these antibodies seem to be associated with exacerbations of kidney disease that are known as renal flares Currently anti-inflammatory and cytotoxic drugs are used to treat renal flares Unfortunately these drugs are often associated with certain unpleasant side effects The purpose of this trial is to determine whether LJP 394 can delay or reduce the number of renal flares It is possible that if renal flares can be delayed or reduced patients may be able to take smaller amounts of anti-inflammatory or cytotoxic drugs and therefore suffer fewer of the side effects associated with these treatments
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