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Open Label Pilot Trial of Rituximab in Lupus Membranous Nephritis

NCT00908986 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-05-14

No results posted yet for this study

Summary

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).

Conditions

Interventions

DRUG

Rituximab

375mg/m2 q week x 4; repeated in 6 months

Sponsors & Collaborators

  • Northwell Health

    lead OTHER

Principal Investigators

  • Cynthia Aranow, MD · Feinstein Institute for Medical Research

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-11-30
Completion
2009-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00908986 on ClinicalTrials.gov