NCT01342016

Brief Summary

The purpose of this study is to compare the efficacy and safety of tacrolimus capsules with leflunomide tablets in the treatment of lupus nephritis.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
84

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

12 active sites

Status
terminated

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

April 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 26, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

October 17, 2014

Status Verified

October 1, 2014

Enrollment Period

2.1 years

First QC Date

April 25, 2011

Last Update Submit

October 15, 2014

Conditions

Lupus Nephritis

Keywords

prografnephritisleflunomideimmunosuppressant

Outcome Measures

Primary Outcomes (1)

  • remission rate (partial remission + complete remission)

    at 6 months after treatment

Secondary Outcomes (4)

  • urinary protein excretion for 24 hrs (24hr proteinuria)

    at 12 weeks and 24 weeks

  • serum albumin level

    at 12 weeks and 24 weeks

  • serum creatinine level

    at 12 weeks and 24 weeks

  • estimated glomerular filtration rate (eGFR)

    at 12 weeks and 24 weeks

Study Arms (2)

tacrolimus group

EXPERIMENTAL

tacrolimus capsule + leflunomide placebo

Drug: tacrolimus capsuleDrug: leflunomide placeboDrug: prednisone

leflunomide group

ACTIVE COMPARATOR

tacrolimus placebo + leflunomide tablet

Drug: tacrolimus placeboDrug: leflunomide tabletDrug: prednisone

Interventions

tacrolimus capsuleDRUG

oral

Also known as: prograf, FK506
tacrolimus group
tacrolimus placeboDRUG

oral

leflunomide group
leflunomide tabletDRUG

oral

Also known as: airuohua
leflunomide group
leflunomide placeboDRUG

oral

tacrolimus group
prednisoneDRUG

oral

leflunomide grouptacrolimus group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • body weight 40-100kg
  • diagnosed as systemic lupus erythematosus, (according to American College of Rheumatology Diagnostic Criteria,1997)
  • diagnosed as type III/ IV of lupus nephritis by renal biopsy within 6 months
  • hr proteinuria ≥2g and/or active urinary sediments

You may not qualify if:

  • receiving immunosuppressant
  • receiving routine treatment of tacrolimus and leflunomide within 1 month
  • receiving nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 months before the study
  • history of allergy to tacrolimus and leflunomide
  • anticipated maintenance dialysis persisted over 8 weeks; or already being dialyzed over 2 weeks before recruitment
  • planning to receive kidney transplantation or in the near future or having a history of undergoing kidney transplantation
  • serum creatinine (Scr) ≥3mg/dl or estimated glomerular filtration rate (eGFR) \< 30ml/min
  • diabetes mellitus patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Unknown Facility

Beijing, China

Location

Unknown Facility

Fujian, China

Location

Unknown Facility

Hubei, China

Location

Unknown Facility

Hunan, China

Location

Unknown Facility

Jiangsu, China

Location

Unknown Facility

Jilin, China

Location

Unknown Facility

Liaoning, China

Location

Unknown Facility

Shandong, China

Location

Unknown Facility

Shanghai, China

Location

Unknown Facility

Shanxi, China

Location

Unknown Facility

Sichuan, China

Location

Unknown Facility

Zhejiang, China

Location

MeSH Terms

Conditions

Lupus NephritisNephritis

Interventions

TacrolimusLeflunomidePrednisone

Condition Hierarchy (Ancestors)

GlomerulonephritisKidney 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 ChemicalsIsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Use Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2011

First Posted

April 26, 2011

Study Start

April 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

October 17, 2014

Record last verified: 2014-10

Locations

CN(12)