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

NCT ID: NCT00429377

Last Updated: 2007-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Brief Summary

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

Detailed Description

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Conditions

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Lupus Nephritis

Keywords

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tacrolimus FK506 lupus nephritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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tacrolimus

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Principal Investigators

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Use Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

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Chubu Region, , Japan

Site Status

Hokkaido Region, , Japan

Site Status

Hokuriku Region, , Japan

Site Status

Kansai Region, , Japan

Site Status

Kanto Region, , Japan

Site Status

Shikoku Region, , Japan

Site Status

Tohoku Region, , Japan

Site Status

Countries

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Japan

Other Identifiers

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506-LN02

Identifier Type: -

Identifier Source: org_study_id