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

This study has been terminated.

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

Sponsors and Collaborators:	Wyeth Trubion Pharmaceuticals
Information provided by:	Wyeth
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 I

MedlinePlus related topics: Lupus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics Study
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

Further study details as provided by Wyeth:

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
1: Experimental	Drug: TRU-015 Arm 1 = 800 mg Arm 2 = 2000 mg
2: Experimental	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

Rochester, New York, United States, 14642

Lake Success, New York, United States, 11042
United States, North Carolina

Charlotte, North Carolina, United States, 28208
United States, Ohio

Columbus, Ohio, United States, 43210

Sponsors and Collaborators

Wyeth

Trubion Pharmaceuticals

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3206K3-103
Study First Received:	May 25, 2007
Last Updated:	May 7, 2008
ClinicalTrials.gov Identifier:	NCT00479622 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Membranous Nephropathy
Systemic Lupus Erythematosus

Study placed in the following topic categories:

Glomerulonephritis
Autoimmune Diseases
Urologic Diseases
Lupus Erythematosus, Systemic
Lupus
Nephritis

Connective Tissue Diseases
Neoplasm Metastasis
Glomerulonephritis, Membranous
Kidney Diseases
Membranous Nephropathy, Idiopathic

Additional relevant MeSH terms:

Glomerulonephritis
Autoimmune Diseases
Immune System Diseases
Urologic Diseases
Lupus Erythematosus, Systemic

Nephritis
Connective Tissue Diseases
Glomerulonephritis, Membranous
Kidney Diseases

ClinicalTrials.gov processed this record on May 07, 2009