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

May 7, 2008 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
      • Palo Alto, California, United States, 94304
    • New York
      • Lake Success, New York, United States, 11042
      • Rochester, New York, United States, 14642
    • North Carolina
      • Charlotte, North Carolina, United States, 28208
    • Ohio
      • Columbus, Ohio, United States, 43210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Collaborators

Emergent Product Development Seattle LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

May 25, 2007

First Submitted That Met QC Criteria

May 25, 2007

First Posted (Estimate)

May 28, 2007

Study Record Updates

Last Update Posted (Estimate)

May 8, 2008

Last Update Submitted That Met QC Criteria

May 7, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3206K3-103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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