Study of TRU-015 in Subjects With Membranous Nephropathy Secondary to Systemic Lupus Erythematosus
A Randomized, Two-Arm, Parallel Group Study of the Safety, Pharmacokinetics, and Pharmacodynamics of TRU-015 Added to Standard Therapy in Subjects With Membranous Nephropathy Secondary to Systemic Lupus Erythematosus
1 other identifier
interventional
20
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2007
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2007
CompletedFirst Posted
Study publicly available on registry
May 28, 2007
CompletedStudy Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedMay 8, 2008
May 1, 2008
9 months
May 25, 2007
May 7, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the pharmacokinetics of TRU-015 after a single administration in subjects with membranous nephropathy secondary to systemic lupus erythematosus.
6 months
Secondary Outcomes (1)
To evaluate the safety, immunogenicity, and pharmacokinetic/pharmacodynamic relationship of TRU-015 in subjects with membranous nephropathy secondary to systemic lupus erythematosus.
1 year
Study Arms (2)
1
EXPERIMENTAL2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Unknown Facility
Los Angeles, California, 90048, United States
Unknown Facility
Palo Alto, California, 94304, United States
Unknown Facility
Lake Success, New York, 11042, United States
Unknown Facility
Rochester, New York, 14642, United States
Unknown Facility
Charlotte, North Carolina, 28208, United States
Unknown Facility
Columbus, Ohio, 43210, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 25, 2007
First Posted
May 28, 2007
Study Start
August 1, 2007
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
May 8, 2008
Record last verified: 2008-05