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

Information source: Astellas Pharma Inc
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lupus Nephritis

Intervention: tacrolimus (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Use Central Contact, Study Director, Affiliation: Astellas Pharma Inc


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

Clinical Details

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change of Lupus Nephritis - Disease Activity Index total score

Secondary outcome: proteinuria, RBC-urine, serum creatinine, anti ds-DNA antibody, complement (C3)


Minimum age: 16 Years. Maximum age: 64 Years. Gender(s): Both.


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


- CNS( Central Nerve System) Lupus patients

- hepatic failure patients

- Serum creatinine ≧1. 5mg/dL

Locations and Contacts

Hokkaido region, Japan

Tohoku region, Japan

Kanto region, Japan

Hokuriku region, Japan

Chubu region, Japan

Kansai region, Japan

Shikoku region, Japan

Additional Information

Starting date: June 2003
Last updated: January 29, 2007

Page last updated: March 21, 2008

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