Study of TRU-015 in Subjects With Membranous Nephropathy Secondary to Systemic Lupus Erythematosus
This study has been terminated.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Collaborator:
Emergent Product Development Seattle LLC
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00479622
First received: May 25, 2007
Last updated: May 7, 2008
Last verified: May 2008
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Systemic Lupus Erythematosus |
Drug: TRU-015 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 20 |
| Study Start Date: | August 2007 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00479622
Please refer to this study by its ClinicalTrials.gov identifier: NCT00479622
Locations
| 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
| Study Director: | Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer |
More Information
| Responsible Party: | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth |
| ClinicalTrials.gov Identifier: | NCT00479622 History of Changes |
| Other Study ID Numbers: | 3206K3-103 |
| Study First Received: | May 25, 2007 |
| Last Updated: | May 7, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
|
Membranous Nephropathy Systemic Lupus Erythematosus |
Additional relevant MeSH terms:
|
Kidney Diseases Lupus Erythematosus, Systemic Glomerulonephritis, Membranous Urologic Diseases Connective Tissue Diseases |
Autoimmune Diseases Immune System Diseases Glomerulonephritis Nephritis |
ClinicalTrials.gov processed this record on September 27, 2016