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

This study has been completed.
Information provided by:
Astellas Pharma Inc Identifier:
First received: January 29, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
This study consists of a 28-week placebo-controlled double-blind inter-group efficacy study in steroid refractory Lupus Nephritis patients.

Condition Intervention Phase
Lupus Nephritis
Drug: tacrolimus
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase 3 Study of Tacrolimus(FK506)for Lupus Nephritis: A Placebo Controlled, Double-Blind Multicenter, Comparative Study

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Change of Lupus Nephritis - Disease Activity Index total score

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

Estimated Enrollment: 64
Study Start Date: June 2003

Ages Eligible for Study:   16 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00429377

Chubu region, Japan
Hokkaido region, Japan
Hokuriku region, Japan
Kansai region, Japan
Kanto region, Japan
Shikoku region, Japan
Tohoku region, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Use Central Contact Astellas Pharma Inc
  More Information Identifier: NCT00429377     History of Changes
Other Study ID Numbers: 506-LN02 
Study First Received: January 29, 2007
Last Updated: January 29, 2007
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Astellas Pharma Inc:
lupus nephritis

Additional relevant MeSH terms:
Lupus Nephritis
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Kidney Diseases
Lupus Erythematosus, Systemic
Urologic Diseases
Calcineurin Inhibitors
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 25, 2016