Phase 3 Study of Tacrolimus (FK506) for Lupus Nephritis: A Placebo Controlled, Double-Blind Multicenter, Comparative Study

January 29, 2007 updated by: Astellas Pharma Inc

Phase 3 Study of Tacrolimus(FK506)for Lupus Nephritis: A Placebo Controlled, Double-Blind Multicenter, Comparative Study

This study consists of a 28-week placebo-controlled double-blind inter-group efficacy study in steroid refractory Lupus Nephritis patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

64

Phase

  • Phase 3

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

  • Japan
      • Chubu region, Japan
      • Hokkaido region, Japan
      • Hokuriku region, Japan
      • Kansai region, Japan
      • Kanto region, Japan
      • Shikoku region, Japan
      • Tohoku region, Japan

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

16 years to 64 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Steroid refractory lupus nephritis

    • more than 10mg of steroid failed to control disease activity
    • patients who failed to reduce the amount of steroid
    • patients who couldn't increase the amount of steroid due to side effects

Exclusion Criteria:

  • Patients who started the immunosuppressant therapy or increased the amount of immunosuppressant within 12 weeks prior to test drug administration
  • Patients who received cyclophosphamide puls within 24 weeks prior to test drug administration
  • CNS( Central Nerve System) Lupus patients
  • hepatic failure patients
  • Serum creatinine ≧1.5mg/dL

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
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change of Lupus Nephritis - Disease Activity Index total score

Secondary Outcome Measures

Outcome Measure
proteinuria, RBC-urine, serum creatinine, anti ds-DNA antibody, complement (C3)

Collaborators and Investigators

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

Sponsor

Astellas Pharma Inc

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

June 1, 2003

Study Registration Dates

First Submitted

January 29, 2007

First Submitted That Met QC Criteria

January 29, 2007

First Posted (ESTIMATE)

January 31, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

January 31, 2007

Last Update Submitted That Met QC Criteria

January 29, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 506-LN02

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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