NCT00429377

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2007

Completed
Last Updated

January 31, 2007

Status Verified

January 1, 2007

First QC Date

January 29, 2007

Last Update Submit

January 29, 2007

Conditions

Lupus Nephritis

Keywords

tacrolimusFK506lupus nephritis

Outcome Measures

Primary Outcomes (1)

  • Change of Lupus Nephritis - Disease Activity Index total score

Secondary Outcomes (1)

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

Interventions

tacrolimusDRUG

Eligibility Criteria

Age16 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Chubu Region, Japan

Location

Unknown Facility

Hokkaido Region, Japan

Location

Unknown Facility

Hokuriku Region, Japan

Location

Unknown Facility

Kansai Region, Japan

Location

Unknown Facility

Kanto Region, Japan

Location

Unknown Facility

Shikoku Region, Japan

Location

Unknown Facility

Tohoku Region, Japan

Location

MeSH Terms

Conditions

Lupus Nephritis

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLupus Erythematosus, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Use Central Contact

    Astellas Pharma Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 29, 2007

First Posted

January 31, 2007

Study Start

June 1, 2003

Last Updated

January 31, 2007

Record last verified: 2007-01

Locations

JP(7)