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

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NCT00479622

Last updated on December 6, 2018
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FOR MORE INFORMATION
Study Location
Los Angeles, California, 90048 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Systemic Lupus Erythematosus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 ( equivalent) for 2 months before study day 1.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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 ( equivalent) for 2 months before study day 1.

NCT00479622
Pfizer
Terminated
Study of TRU-015 in Subjects With Membranous Nephropathy Secondary to Systemic Lupus Erythematosus

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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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Systemic Lupus Erythematosus
Drug: TRU-015
Arm 1 = 800 mg Arm 2 = 2000 mg
  • Experimental: 1
    Intervention: Drug: TRU-015
  • Experimental: 2
    Intervention: Drug: TRU-015
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
May 2008
May 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00479622
3206K3-103
No
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Emergent Product Development Seattle LLC
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
May 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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