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

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 |
- 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 ]
- 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 ]

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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 |
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.

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
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 |
Study Director: | Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer |
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 |
Membranous Nephropathy Systemic Lupus Erythematosus |
Kidney Diseases Glomerulonephritis, Membranous Lupus Erythematosus, Systemic Urologic Diseases Connective Tissue Diseases |
Autoimmune Diseases Immune System Diseases Glomerulonephritis Nephritis |