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

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ClinicalTrials.gov Identifier: NCT00479622
Recruitment Status : Terminated
First Posted : May 28, 2007
Last Update Posted : May 8, 2008
Sponsor:
Collaborator:
Emergent Product Development Seattle LLC
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: TRU-015 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: TRU-015
Arm 1 = 800 mg Arm 2 = 2000 mg
Experimental: 2 Drug: TRU-015
Arm 1 = 800 mg Arm 2 = 2000 mg


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the pharmacokinetics of TRU-015 after a single administration in subjects with membranous nephropathy secondary to systemic lupus erythematosus. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. To evaluate the safety, immunogenicity, and pharmacokinetic/pharmacodynamic relationship of TRU-015 in subjects with membranous nephropathy secondary to systemic lupus erythematosus. [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00479622


Locations
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United States, California
Los Angeles, California, United States, 90048
Palo Alto, California, United States, 94304
United States, New York
Lake Success, New York, United States, 11042
Rochester, New York, United States, 14642
United States, North Carolina
Charlotte, North Carolina, United States, 28208
United States, Ohio
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Emergent Product Development Seattle LLC
Investigators
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Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
More Information
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Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00479622    
Other Study ID Numbers: 3206K3-103
First Posted: May 28, 2007    Key Record Dates
Last Update Posted: May 8, 2008
Last Verified: May 2008
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Membranous Nephropathy
Systemic Lupus Erythematosus
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, Membranous
Lupus Erythematosus, Systemic
Urologic Diseases
Connective Tissue Diseases
 Autoimmune Diseases
Immune System Diseases
Glomerulonephritis
Nephritis