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

Phase 1TerminatedNCT00479622

Wyeth is now a wholly owned subsidiary of Pfizer20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Systemic Lupus Erythematosus

Interventions

TRU-015DRUG

Arm 1 = 800 mg Arm 2 = 2000 mg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (6)

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Palo Alto, California, United States

Unnamed facility

Lake Success, New York, United States

Unnamed facility

Rochester, New York, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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