Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00282347
Status:
COMPLETED
Last Update Posted:
2015-01-15
First Post:
2006-01-24
Brief Title:
A Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With International Society of NephrologyRenal Pathology Society ISNRPS 2003 Class III or IV Lupus Nephritis
Sponsor:
Genentech Inc
Organization:
Genentech Inc
Study Overview
Official Title:
A Phase III Randomized Double-Blind Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With ISNRPS Class III or IV Lupus Nephritis
Status:
COMPLETED
Status Verified Date:
2015-01
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:
LUNAR
Brief Summary:
This was a Phase III randomized double-blind placebo-controlled multicenter study to evaluate the efficacy and safety of rituximab in combination with mycophenolate mofetil MMF compared with placebo in combination with MMF in subjects diagnosed with International Society of NephrologyRenal Pathology Society ISNRPS 2003 Class III or IV lupus nephritis
Detailed Description:
In addition to receiving study drug rituximab or placebo participants in each treatment group received mycophenolate mofetil at a starting dose of 1500 mgday IV in 3 divided doses and were titrated up by 500 mgweek to 3000 mgday by Week 4 as tolerated Participants in each treatment group also received methylprednisolone 1000 mg IV prior to and 3 days following the first study drug infusion and methylprednisolone 100 mg IV prior to the other study drug infusions Participants in each treatment group also received diphenhydramine 50 mg orally and acetaminophen 1000 mg orally 30-60 minutes prior to each study drug infusion From Days 2 to 16 participants in each treatment group received prednisone 075 mgkgday orally maximum dose of 60 mg except on the day of the second methylprednisolone dose On Day 16 a taper was initiated to achieve a dose of 10 mgday by Week 16
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