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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00429377

Enrollment

Registered

2007-01-31

Start date

2003-06-30

Completion date

Unknown

Last updated

2007-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus Nephritis

Keywords

tacrolimus, FK506, lupus nephritis

Brief summary

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

Interventions

DRUGtacrolimus

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

16 Years to 64 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change of Lupus Nephritis - Disease Activity Index total score	—

Secondary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026