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

Phase 1

Terminated

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: TRU-015

• Registration Number: NCT00479622
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-05-25
• Study First Submitted QC: 2007-05-25
• Study First Posted: 2007-05-28
• Study Start: 2007-08
• Status Verified: 2008-05
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Last Update Submitted: 2008-05-07
• Last Update Posted: 2008-05-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	TRU-015	-
2	TRU-015	-

Primary Outcome Measures

Name	Time	Method
To evaluate the pharmacokinetics of TRU-015 after a single administration in subjects with membranous nephropathy secondary to systemic lupus erythematosus.	6 months

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety, immunogenicity, and pharmacokinetic/pharmacodynamic relationship of TRU-015 in subjects with membranous nephropathy secondary to systemic lupus erythematosus.	1 year