Systemic Lupus Erythematosus
Conditions
Keywords
Membranous Nephropathy, Systemic Lupus Erythematosus
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.
Interventions
DRUGTRU-015
Arm 1 = 800 mg Arm 2 = 2000 mg
Sponsors
Emergent Product Development Seattle LLC
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the pharmacokinetics of TRU-015 after a single administration in subjects with membranous nephropathy secondary to systemic lupus erythematosus. | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety, immunogenicity, and pharmacokinetic/pharmacodynamic relationship of TRU-015 in subjects with membranous nephropathy secondary to systemic lupus erythematosus. | 1 year |
Countries
United States
Outcome results
None listed