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

This study has been terminated.

First Received on May 25, 2007. Last Updated on May 7, 2008 History of Changes

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

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:

MedlinePlus related topics: Lupus

U.S. FDA Resources

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
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

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

No publications provided

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:

Glomerulonephritis, Membranous
Kidney Diseases
Lupus Erythematosus, Systemic
Glomerulonephritis
Nephritis

Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 22, 2012