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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00429377
First received: January 29, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  Purpose

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:

Drug Information available for: Tacrolimus
U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   16 Years to 64 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00429377

Locations
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
Study Director: Use Central Contact Astellas Pharma Inc
  More Information

No publications provided

ClinicalTrials.gov 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:
tacrolimus
FK506
lupus nephritis

Additional relevant MeSH terms:
Lupus Nephritis
Nephritis
Glomerulonephritis
Kidney Diseases
Urologic Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
 Autoimmune Diseases
Immune System Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013