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

Wyeth

Status and phase: Terminated; Phase 1

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: TRU-015

Study type: Interventional

Funder types: Industry

Identifiers

NCT00479622

3206K3-103

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: TRU-015

2

Experimental group

Treatment:

Drug: TRU-015