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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00429377
Recruitment Status : Completed
First Posted : January 31, 2007
Last Update Posted : January 31, 2007
Sponsor:
Information provided by:
Astellas Pharma Inc

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

Condition or disease Intervention/treatment Phase
Lupus Nephritis Drug: tacrolimus Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase 3 Study of Tacrolimus(FK506)for Lupus Nephritis: A Placebo Controlled, Double-Blind Multicenter, Comparative Study
Study Start Date : June 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Change of Lupus Nephritis - Disease Activity Index total score

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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00429377


Locations
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Japan
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
Investigators
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Study Director: Use Central Contact Astellas Pharma Inc
More Information
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ClinicalTrials.gov Identifier: NCT00429377    
Other Study ID Numbers: 506-LN02
First Posted: January 31, 2007    Key Record Dates
Last Update Posted: January 31, 2007
Last Verified: January 2007
Keywords provided by Astellas Pharma Inc:
tacrolimus
FK506
lupus nephritis
Additional relevant MeSH terms:
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Nephritis
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Glomerulonephritis
Lupus Erythematosus, Systemic
 Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action