Open Label Pilot Trial of Rituximab in Lupus Membranous Nephritis

Sponsor
Northwell Health
Study ID
NCT00908986
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    375mg/m2 q week x 4; repeated in 6 months

Study Details

The objective of this study is to assess the as efficacy of rituximab as induction therapy in membranous lupus nephritis. Safety and tolerability will additionally be assessed. Subjects will receive open-label 2 courses of rituximab at baseline and at 6 months. They will be followed monthly for 18 months to assess response and durability of response. The hypothesis: B cell depletion will be an effective safe and well tolerated treatment for membranous lupus nephritis (Class V).

Key Dates

Start date
Dec 31, 2008
Status verified
May 2015
Primary completion
Nov 30, 2009
Completion
Nov 30, 2009

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab
    Subjects receive rituximab in an open label manner

Primary Outcome Measure

Efficacy at 6 months post treatment and durability of response at 12 months post treatment will be determined by: reduction in 24 hour urinary protein excretion, reciprocal creatinine, urinary sediment [ Time Frame: 12 months ]

Related Studies