Study of TRU-015 in Subjects With Membranous Nephropathy Secondary to Systemic Lupus Erythematosus

• Status: Terminated
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine how the body absorbs and chemically changes a single infusion of TRU-015 in subjects with kidney disease caused by lupus.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Collaborator: Emergent Product Development Seattle LLC

Criteria

Inclusion Criteria:

• Man or nonlactating and nonpregnant woman, aged 18 to 70 years, inclusive, at the screening visit.

• Diagnosis of systemic lupus erythematosus more than 6 months before study day 1.

• History of positive antinuclear antibody titer of >1:160 or equivalent.

• Biopsy-proven class V lupus nephritis within the last 2 years.

• Have been on a stable dose of oral corticosteroids (<20 mg/day prednisone or equivalent) for 2 months before study day 1.